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1.  A systematic review of interventions aimed at increasing physical activity in adults with chronic musculoskeletal pain—protocol 
Systematic Reviews  2014;3:106.
Background
Chronic musculoskeletal pain is highly prevalent, affecting around one in five people across Europe. Osteoarthritis, low back pain, neck pain and other musculoskeletal disorders are leading causes of disability worldwide and the most common source of chronic pain. Exercise and/or physical activity interventions have the potential to address not only the pain and disability associated with chronic pain but also the increased risk of morbidity and mortality seen in this population. Although exercise and/or physical activity is widely recommended, there is currently a paucity of research that offers an evidence base upon which the development or optimisation of interventions can be based. This systematic review will investigate the components of interventions associated with changes in physical activity levels in adults with chronic musculoskeletal pain.
Methods/Design
This systematic review will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidance. Randomised and quasi-randomised controlled trials of interventions aimed at increasing physical activity in adults with chronic musculoskeletal pain will be included. Articles will be identified through a comprehensive search of the following databases: CENTRAL in the Cochrane Library, the Cochrane Database of Systematic Reviews (CDSR), MEDLINE, Embase, CINAHL, PsycINFO and AMED. Two review authors will independently screen articles retrieved from the search for eligibility, extract relevant data on methodological issues and code interventions according to the behaviour change technique taxonomy (v1) of 93 hierarchically clustered techniques. As complex healthcare interventions can be modified by a wide variety of factors, data will be summarised statistically when the data are available, are sufficiently similar and are of sufficient quality. A narrative synthesis will be completed if there is insufficient data to permit a formal meta-analysis.
Discussion
This review will be of value to clinicians working in chronic pain services and to researchers involved in designing and evaluating interventions.
Systematic review registration
PROSPERO reference: CRD42014010640.
doi:10.1186/2046-4053-3-106
PMCID: PMC4179220  PMID: 25239378
Chronic pain; Low back pain; Osteoarthritis; Physical activity; Exercise; Randomised controlled trials
2.  What is the prevalence of musculoskeletal problems in the elderly population in developed countries? A systematic critical literature review 
Background
The proportion of older people will be tripled by the year 2050. In addition, the incidence of chronic musculoskeletal (MSK) conditions will also increase among the elderly people. Thus, in order to prepare for future health care demands, the magnitude and impact of MSK conditions from this growing population is needed. The objective of this literature review is to determine the current prevalence of MSK disorders in the elderly population.
Methods
A systematic literature search was conducted in Pubmed on articles in English, published between January 2000 and July 2011. Studies from developed countries with prevalence estimates on elderly people (60+) on the following MSK conditions were included: Non-specific extremity pain, rheumatoid arthritis, osteoarthritis, osteoporosis, and back pain. The included articles were extracted for information and assessed for risk of bias.
Results
A total of 85 articles were included with 173 different prevalence estimates. Musculoskeletal disorders are common in the elderly population, but due to heterogeneity of the studies, no general estimate on the prevalence of MSK can be determined. Women report more often MSK pain than men. Overall, prevalence estimates either remain fairly constant or increase slightly with increasing age, but with a tendency to decrease in the oldest (80+) people.
Conclusions
Musculoskeletal disorders remain prevalent in the elderly population. Given the increasing proportion of elderly population in the world population and the burden of MSK diseases among the elderly people, efforts must be made to maintain their functional capacity for as long as possible through optimal primary and secondary health care.
doi:10.1186/2045-709X-20-31
PMCID: PMC3507809  PMID: 23006836
Systematic literature review; Musculoskeletal disease; Elderly population; Osteoarthritis; Rheumatoid arthritis; Osteoporosis; Back pain
3.  Risk Factors for Neck and Upper Extremity Disorders among Computers Users and the Effect of Interventions: An Overview of Systematic Reviews 
PLoS ONE  2011;6(5):e19691.
Background
To summarize systematic reviews that 1) assessed the evidence for causal relationships between computer work and the occurrence of carpal tunnel syndrome (CTS) or upper extremity musculoskeletal disorders (UEMSDs), or 2) reported on intervention studies among computer users/or office workers.
Methodology/Principal Findings
PubMed, Embase, CINAHL and Web of Science were searched for reviews published between 1999 and 2010. Additional publications were provided by content area experts. The primary author extracted all data using a purpose-built form, while two of the authors evaluated the quality of the reviews using recommended standard criteria from AMSTAR; disagreements were resolved by discussion. The quality of evidence syntheses in the included reviews was assessed qualitatively for each outcome and for the interventions.
Altogether, 1,349 review titles were identified, 47 reviews were retrieved for full text relevance assessment, and 17 reviews were finally included as being relevant and of sufficient quality. The degrees of focus and rigorousness of these 17 reviews were highly variable. Three reviews on risk factors for carpal tunnel syndrome were rated moderate to high quality, 8 reviews on risk factors for UEMSDs ranged from low to moderate/high quality, and 6 reviews on intervention studies were of moderate to high quality. The quality of the evidence for computer use as a risk factor for CTS was insufficient, while the evidence for computer use and UEMSDs was moderate regarding pain complaints and limited for specific musculoskeletal disorders. From the reviews on intervention studies no strong evidence based recommendations could be given.
Conclusions/Significance
Computer use is associated with pain complaints, but it is still not very clear if this association is causal. The evidence for specific disorders or diseases is limited. No effective interventions have yet been documented.
doi:10.1371/journal.pone.0019691
PMCID: PMC3093401  PMID: 21589875
4.  Musculoskeletal pain in older adults at the end-of-life: a systematic search and critical review of the literature with priorities for future research 
BMC Palliative Care  2013;12:27.
Background
Pain is an important issue in end of life care. Although musculoskeletal pain is common in older adults, it is rarely associated with the cause of death and may be overlooked as death approaches. Hence a major target for improving quality of life may be being missed.
Methods
The aim of this study was to systematically search and critically review the literature on musculoskeletal pain at the end of life. Amed, Cinahl, Internurse, Medline, Psych Info, Web of Knowledge and Cochrane review databases were searched for relevant research up to September 2012. The search strategy combined key words expanding the terms ‘palliative’ for population, ‘musculoskeletal’ for exposure, and ‘pain’ for outcome. Predefined inclusion and exclusion criteria were applied.
Results
Five relevant papers and one letter to the editor were found, including case studies and epidemiological research. Current evidence suggests musculoskeletal pain is common in older adults at the end of life and that it can have a substantial impact on individual experience. No information about community based treatment of musculoskeletal pain at the end of life was found.
Conclusion
Priorities for future research include high quality epidemiological studies to establish the prevalence, natural history, impact, assessment, patient priorities and outcomes associated with musculoskeletal pain in the end of life period, and intervention research that provides an evidence base for treatment.
doi:10.1186/1472-684X-12-27
PMCID: PMC3733865  PMID: 23885745
Palliative; Pain; Musculoskeletal; End of life; Systematic review
5.  Balloon Kyphoplasty 
Executive Summary
Objective
To review the evidence on the effectiveness and cost-effectiveness of balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs).
Clinical Need
Vertebral compression fractures are one of the most common types of osteoporotic fractures. They can lead to chronic pain and spinal deformity. They are caused when the vertebral body (the thick block of bone at the front of each vertebra) is too weak to support the loads of activities of daily living. Spinal deformity due to a collapsed vertebral body can substantially affect the quality of life of elderly people, who are especially at risk for osteoporotic fractures due to decreasing bone mass with age. A population-based study across 12 European centres recently found that VCFs have a negative impact on health-related quality of life. Complications associated with VCFs are pulmonary dysfunction, eating disorders, loss of independence, and mental status change due to pain and the use of medications. Osteoporotic VCFs also are associated with a higher rate of death.
VCFs affect an estimated 25% of women over age 50 years and 40% of women over age 80 years. Only about 30% of these fractures are diagnosed in clinical practice. A Canadian multicentre osteoporosis study reported on the prevalence of vertebral deformity in Canada in people over 50 years of age. To define the limit of normality, they plotted a normal distribution, including mean and standard deviations (SDs) derived from a reference population without any deformity. They reported a prevalence rate of 23.5% in women and a rate of 21.5% in men, using 3 SDs from the mean as the limit of normality. When they used 4 SDs, the prevalence was 9.3% and 7.3%, respectively. They also found the prevalence of vertebral deformity increased with age. For people older than 80 years of age, the prevalence for women and men was 45% and 36%, respectively, using 3 SDs as the limit of normality.
About 85% of VCFs are due to primary osteoporosis. Secondary osteoporosis and neoplasms account for the remaining 15%. A VCF is operationally defined as a reduction in vertebral body height of at least 20% from the initial measurement. It is considered mild if the reduction in height is between 20% and 25%; moderate, if it is between 25% and 40%; and severs, if it is more than 40%. The most frequently fractured locations are the third-lower part of the thorax and the superior lumbar levels. The cervical vertebrae and the upper third of the thorax are rarely involved.
Traditionally, bed rest, medication, and bracing are used to treat painful VCFs. However, anti-inflammatory and narcotic medications are often poorly tolerated by the elderly and may harm the gastrointestinal tract. Bed rest and inactivity may accelerate bone loss, and bracing may restrict diaphragmatic movement. Furthermore, medical treatment does not treat the fracture in a way that ameliorates the pain and spinal deformity.
Over the past decade, the injection of bone cement through the skin into a fractured vertebral body has been used to treat VCFs. The goal of cement injection is to reduce pain by stabilizing the fracture. The secondary indication of these procedures is management of painful vertebral fractures caused by benign or malignant neoplasms (e.g., hemangioma, multiple myeloma, and metastatic cancer).
The Technology
Balloon kyphoplasty is a modified vertebroplasty technique. It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and correct kyphosis. During this procedure, an inflatable bone tamp is inserted into the collapsed vertebral body. Once inflated, the balloon elevates the end plates and thereby restores the height of the vertebral body. The balloon is deflated and removed, and the space is filled with bone cement. Creating a space in the vertebral body enables the application of more viscous cement and at a much lower pressure than is needed for vertebroplasty. This may result in less cement leakage and fewer complications. Balloons typically are inserted bilaterally, into each fractured vertebral body. Kyphoplasty usually is done under general anesthesia in about 1.5 hours. Patients typically are observed for only a few hours after the surgery, but some may require an overnight hospital stay.
Health Canada has licensed KyphX Xpander Inflatable Bone Tamp (Kyphon Inc., Sunnyvale, CA), for kyphoplasty in patients with VCFs. KyphX is the only commercially available device for percutaneous kyphoplasty. The KyphX kit uses a series of bone filler device tubes. Each bone filler device must be loaded manually with cement. The cement is injected into the cavity by pressing an inner stylet.
In the United States, the Food and Drug Administration cleared the KyphX Inflatable Bone Tamp for marketing in July 1998. CE (Conformité European) marketing was obtained in February 2000 for the reduction of fracture and/or creation of a void in cancellous bone.
Review Strategy
The aim of this literature review was to evaluate the safety and effectiveness of balloon kyphoplasty in the treatment of painful VCFs.
INAHTA, Cochrane CCTR (formerly Cochrane Controlled Trials Register), and DSR were searched for health technology assessment reports. In addition, MEDLINE, EMBASE, and MEDLINE In-Process & Other Non-Indexed Citations were searched from January 1, 2000 to September 21, 2004. The search was limited to English-language articles and human studies.
The positive end points selected for this assessment were as follows:
Reduction in pain scores
Reduction in vertebral height loss
Reduction in kyphotic (Cobb) angle
Improvement in quality of life scores
The search did not yield any health technology assessments on balloon kyphoplasty. The search yielded 152 citations, including those for review articles. No randomized controlled trials (RCTs) on balloon kyphoplasty were identified. All of the published studies were either prospective cohort studies or retrospective studies with no controls. Eleven studies (all case series) met the inclusion criteria. There was also a comparative study published in German that had been translated into English.
Summary of Findings
The results of the 1 comparative study (level 3a evidence) that was included in this review showed that, compared with conservative medical care, balloon kyphoplasty significantly improved patient outcomes.
Patients who had balloon kyphoplasty reported a significant reduction in pain that was maintained throughout follow-up (6 months), whereas pain scores did not change in the control group. Patients in the balloon kyphoplasty group did not need pain medication after 3 days. In the control group, about one-half of the patients needed more pain medication in the first 4 weeks after the procedure. After 6 weeks, 82% of the patients in the control group were still taking pain medication regularly.
Adjacent fractures were more frequent in the control group than in the balloon kyphoplasty group.
The case series reported on several important clinical outcomes.
Pain: Four studies on osteoporosis patients and 1 study on patients with multiple myeloma/primary cancers used the Visual Analogue Scale (VAS) to measure pain before and after balloon kyphoplasty. All of these studies reported that patients had significantly less pain after the procedure. This was maintained during follow-up. Two other studies on patients with osteoporosis also used the VAS to measure pain and found a significant improvement in pain scores; however, they did not provide follow-up data.
Vertebral body height: All 5 studies that assessed vertebral body height in patients with osteoporosis reported a significant improvement in vertebral body height after balloon kyphoplasty. One study had 1-year follow-up data for 26 patients. Vertebral body height was significantly better at 6 months and 1 year for both the anterior and midline measurements.
Two studies reported that vertebral body height was restored significantly after balloon kyphoplasty for patients with multiple myeloma or metastatic disease. In another study, the researchers reported complete height restoration in 9% of patients, a mean 56% height restoration in 60% of patients, and no appreciable height restoration in 31% of the patients who received balloon kyphoplasty.
Kyphosis correction: Four studies that assessed Cobb angle before and after balloon kyphoplasty in patients with osteoporosis found a significant reduction in degree of kyphosis after the procedure. In these studies, the differences between preoperative and postoperative Cobb angles were 3.4°, 7°, 8.8°, and 9.9°.
Only 1 study investigated kyphosis correction in patients with multiple myeloma or metastatic disease. The authors reported a significant improvement (5.2°) in local kyphosis.
Quality of life: Four studies used the Short Form 36 (SF-36) Health Survey Questionnaire to measure the quality of life in patients with osteoporosis after they had balloon kyphoplasty. A significant improvement in most of the domains of the SF-36 (bodily pain, social functioning, vitality, physical functioning, mental health, and role functioning) was observed in 2 studies. One study found that general health declined, although not significantly, and another found that role emotional declined.
Both studies that used the Oswestry Disability Index found that patients had a better quality of life after balloon kyphoplasty. In one study, this improvement was statistically significant. In another study, researchers found that quality of life after kyphoplasty improved significantly, as measured with the Roland-Morris Disability Questionnaire. Yet another study used a quality of life questionnaire and found that 62% of the patients that had balloon kyphoplasty had returned to normal activities, whereas 2 patients had reduced mobility.
To measure quality of life in patients with multiple myeloma or metastatic disease, one group of researchers used the SF-36 and found significantly better scores on bodily pain, physical functioning, vitality, and social functioning after kyphoplasty. However, the scores for general health, mental health, role physical, and role emotional had not improved. A study that used the Oswestry Disability Index reported that patients’ scores were better postoperatively and at 3 months follow-up.
These were the main findings on complications in patients with osteoporosis:
The bone cement leaked in 37 (6%) of 620 treated fractures.
There were no reports of neurological deficits.
There were no reports of pulmonary embolism due to cement leakage.
There were 6 cases of cardiovascular events in 362 patients:
3 (0.8%) patients had myocardial infarction.
3 (0.8%) patients had cardiac arrhythmias.
There was 1 (0.27%) case of pulmonary embolism due to deep venous thrombosis.
There were 20 (8.4%) cases of new fractures in 238 patients.
For patients with multiple myeloma or metastatic disease, these were the main findings:
The bone cement leaked in 12 (9.6%) of 125 procedures.
There were no reports of neurological deficits.
Economic Analysis
Balloon kyphoplasty requires anesthesia. Standard vertebroplasty requires sedation and an analgesic. Based on these considerations, the professional fees (Cdn) for each procedure is shown in Table 1.
Professional Fees for Standard Vertebroplasty and Balloon Kyphoplasty
Balloon kyphoplasty has a sizable device cost add-on of $3,578 (the device cost per case) that standard vertebroplasty does not have. Therefore, the up-front cost (i.e., physician’s fees and device costs) is $187 for standard vertebroplasty and $3,812 for balloon kyphoplasty. (All costs are in Canadian currency.)
There are also “downstream costs” of the procedures, based on the different adverse outcomes associated with each. This includes the risk of developing new fractures (21% for vertebroplasty vs. 8.4% for balloon kyphoplasty), neurological complications (3.9% for vertebroplasty vs. 0% for balloon kyphoplasty), pulmonary embolism (0.1% for vertebroplasty vs. 0% for balloon kyphoplasty), and cement leakage (26.5% for vertebroplasty vs. 6.0% for balloon kyphoplasty). Accounting for these risks, and the base costs to treat each of these complications, the expected downstream costs are estimated at less than $500 per case. Therefore, the expected total direct medical cost per patient is about $700 for standard vertebroplasty and $4,300 for balloon kyphoplasty.
Kyphon, the manufacturer of the inflatable bone tamps has stated that the predicted Canadian incidence of osteoporosis in 2005 is about 29,000. The predicted incidence of cancer-related vertebral fractures in 2005 is 6,731. Based on Ontario having about 38% of the Canadian population, the incidence in the province is likely to be about 11,000 for osteoporosis and 2,500 for cancer-related vertebral fractures. This means there could be as many as 13,500 procedures per year in Ontario; however, this is highly unlikely because most of the cancer-related fractures likely would be treated with medication. Given a $3,600 incremental direct medical cost associated with balloon kyphoplasty, the budget impact of adopting this technology could be as high as $48.6 million per year; however, based on data from the Provider Services Branch, about 120 standard vertebroplasties are done in Ontario annually. Given these current utilization patterns, the budget impact is likely to be in the range of $430,000 per year. This is because of the sizable device cost add-on of $3,578 (per case) for balloon kyphoplasty that standard vertebroplasty does not have.
Policy Considerations
Other treatments for osteoporotic VCFs are medical management and open surgery. In cases without neurological involvement, the medical treatment of osteoporotic VCFs comprises bed rest, orthotic management, and pain medication. However, these treatments are not free of side effects. Bed rest over time can result in more bone and muscle loss, and can speed the deterioration of the underlying condition. Medication can lead to altered mood or mental status. Surgery in these patients has been limited because of its inherent risks and invasiveness, and the poor quality of osteoporotic bones. However, it may be indicated in patients with neurological deficits.
Neither of these vertebral augmentation procedures eliminates the need for aggressive treatment of osteoporosis. Osteoporotic VCFs are often under-diagnosed and under-treated. A survey of physicians in Ontario (1) who treated elderly patients living in long-term care homes found that although these physicians were aware of the rates of osteoporosis in these patients, 45% did not routinely assess them for osteoporosis, and 26% did not routinely treat them for osteoporosis.
Management of the underlying condition that weakens the vertebral bodies should be part of the treatment plan. All patients with osteoporosis should be in a medical therapy program to treat the underlying condition, and the referring health care provider should monitor the clinical progress of the patient.
The main complication associated with vertebroplasty and balloon kyphoplasty is cement leakage (extravertebral or vascular). This may result in more patient morbidity, longer hospitalizations, the need for open surgery, and the use of pain medications, all of which have related costs. Extravertebral cement leakage can cause neurological complications, like spinal cord compression, nerve root compression, and radiculopathy. In some cases, surgery is required to remove the cement and release the nerve. The rate of cement leakage is much lower after balloon kyphoplasty than after vertebroplasty. Furthermore, the neurological complications seen with vertebroplasty have not seen in the studies of balloon kyphoplasty. Rarely, cement leakage into the venous system will cause a pulmonary embolism. Finally, compared with vertebroplasty, the rate of new fractures is lower after balloon kyphoplasty.
Diffusion – International, National, Provincial
In Canada, balloon kyphoplasty has not yet been funded in any of the provinces. The first balloon kyphoplasty performed in Canada was in July 2004 in Ontario.
In the United States, the technology is considered by some states as medically reasonable and necessary for the treatment of painful vertebral body compression fractures.
Conclusion
There is level 4 evidence that balloon kyphoplasty to treat pain associated with VCFs due to osteoporosis is as effective as vertebroplasty at relieving pain. Furthermore, the evidence suggests that it restores the height of the affected vertebra. It also results in lower fracture rates in other vertebrae compared with vertebroplasty, and in fewer neurological complications due to cement leakage compared with vertebroplasty. Balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies.
Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Therefore, consideration should be given to limiting the number of facilities in the province that can do balloon kyphoplasty.
PMCID: PMC3387743  PMID: 23074451
6.  Playing-related musculoskeletal disorders in musicians: a systematic review of incidence and prevalence 
BACKGROUND: Work-related musculoskeletal disorders cause pain, disability and loss of employment for many workers, including musicians. Although performing arts medicine is a growing field, the health problems of musicians remain under-recognized and under-researched. Therefore, the author undertook a systematic review of published information on the incidence and prevalence of playing-related musculoskeletal disorders (PRMDs) in classical musicians. METHODS: Seven databases were searched for the period 1980 to 1996. The main textbook and performing arts medicine journals were searched manually, as were reference lists of all relevant papers. The author also contacted individuals familiar with the literature of performing arts medicine. Studies were included for review if they reported PRMD incidence or prevalence in classical musicians. Of the 24 studies identified, 18 cross-sectional surveys and cohort studies were reviewed. The author subjectively assessed the studies using criteria modified from an existing evaluation scale and used 4 criteria for data combination. On the basis of prevalence values from the eligible studies, chi 2 tests for heterogeneity were performed. RESULTS: Only one study estimated PRMD incidence. Ten of the 17 prevalence studies were ineligible for data combination, because of low response rates and other methodological problems. In the 7 eligible studies, PRMD point prevalence ranged from 39% to 87% in adult musicians and from 34% to 62% in secondary school music students. The best estimates of PRMD prevalence were derived from the 3 studies that excluded mild complaints; these studies indicated that PRMD prevalence was 39% and 47% in adults and 17% in secondary school music students respectively. Statistical combination of data across studies within each demographic category was not possible. INTERPRETATION: Available data indicate that the prevalence of PRMD in adult classical musicians is comparable to the prevalence of work-related musculoskeletal disorders reported for other occupational groups. Several recommendations for future research are outlined.
PMCID: PMC1229223  PMID: 9580730
7.  Bracing and Taping Techniques and Patellofemoral Pain Syndrome 
Journal of Athletic Training  2012;47(3):358-359.
Reference/Citation:
D'hondt NE, Struijs PA, Kerkhoffs GM, et al. Orthotic devices for treating patellofemoral pain syndrome. Cochrane Database Syst Rev. 2002;(2):CD002267.
Clinical Question:
Is there an effective bracing or taping technique for treating patellofemoral pain?
Data Sources:
The authors searched the Cochrane Musculoskeletal Injuries Group specialized register (December 2001), the Cochrane Controlled Trials Register (2000, issue 2), MEDLINE (January 1966 to March 2000), EMBASE (January 1988 to March 2000), CINAHL (January 1982 to March 2000), and PEDro (up to March 2000) without language limitations. They also contacted relevant orthotic companies and searched the included reference lists of the retrieved articles. The search terms for MEDLINE were anterior knee pain, arthralgia, knee joint, patella, and patellofemoral pain. The search terms for EMBASE were brace, chondropathy, dynamic splint, knee, orthosis, orthotics, patella, patella chondromalacia, patellofemoral joint, randomized control trial, and strap. The search terms for CINAHL were anterior knee pain, brace, orthot, orthos, randomi, strap, tape, patell, and patellofemoral. In PEDro, the subsequent composite of search terms was therapy: manipulation, massage, mobilization, orthoses, splinting, stretching, strength training, taping; subdiscipline: musculoskeletal, orthopaedics, sports; method: clinical trial; problem: muscle weakness, pain, reduced joint compliance; body part: foot or ankle, lower leg or knee.
Study Selection:
All randomized and quasi-randomized trials comparing the effectiveness of knee or foot orthotics for treatment of patellofemoral pain syndrome were included. Any trials that described the use of orthotic devices in conjunction with operative treatment were excluded from this review. Using these inclusion criteria, 2 reviewers independently assessed the potentially eligible studies and resolved any disagreements through conversation and negotiation by a third reviewer. Although the authors mentioned that the review's purpose was to assess knee and foot orthoses, none of the included studies assessed foot orthoses. Therefore, all trials that examined foot orthotics were excluded.
Data Extraction:
Using a preset extraction form, 2 reviewers independently entered data into a review manager software program (RevMan 2000; The Cochrane Collaboration, Oxford, United Kingdom). This program was produced by the Cochrane Collaboration to support systematic reviews. Any further information needed regarding methods and data was requested from the authors. Because of heterogeneity of the study population, interventions, and follow-up periods, statistical pooling was not conducted. In place of statistical pooling, the strength of scientific evidence was graded based on a scale of A through D, with A being the strongest evidence-based research and D being the weakest evidence-based research.
Main Results:
The search strategy identified 15 trials, of which only 5 trials met all the inclusion criteria and had enough data to be considered for pooling. The 5 trials involved 362 participants who were assessed for pain, functional improvement, isokinetic muscular strength, motivation, subjective success, worst pain, usual pain, subjective clinical pain, and patellofemoral congruence angle. Of the 5 studies included in the review, only the following statistically significant differences were found. The Protonics orthosis significantly decreased pain and improved function based on the Kujala score versus no treatment. A home exercise program with McConnell taping and biofeedback decreased pain and improved function based on the Functional Index Questionnaire versus home exercise and monitored therapy. In addition, the Protonics orthosis versus no treatment resulted in a patellofemoral congruence angle change; McConnell taping versus Couman bandage improved satisfaction with applied therapy and isokinetic muscle strength at 300°/s of knee flexion. No other findings included in the review studies were statistically significant. The included studies were inadequate in their methodologic quality and incomplete in their research-based evidence, which was obtained by their investigators.
Conclusions:
According to the systematic review by D'hondt et al, the strength of retrieved research-based evidence of effectiveness of orthotic devices in the treatment of patellofemoral pain syndrome was graded C. This grade was appropriate because all trials had low-quality methodologic evidence to support or reject the effectiveness of orthotics and taping techniques in reducing pain. Although very little scientific evidence is available regarding the use of orthotics and taping techniques, D'hondt et al identified trends in orthotics and taping techniques that should be considered in clinical practice. A comprehensive exercise and stretching program with tape application was more effective in decreasing worst pain and usual pain and increasing functional improvement. This finding indicates that patellofemoral pain syndrome is best treated by using more than 1 intervention. In addition, no difference was apparent in pain outcomes between McConnell taping technique and Couman bandage: neither technique resolved pain. The Protonics orthosis actively affected patellar tracking by reducing internal rotation of the femur and compression on the lateral aspect of the patella. As a result, the Protonics orthosis reduced pain compared with no treatment. In contrast, the Couman bandage is used only to guide the patellar tracking pattern and massage the structures around the patella during motion. Yet a home exercise program with the addition of a stretching program and McConnell taping decreased pain and increased function, which may suggest that a combination of treatment approaches is needed to effectively treat the condition, as found in previous studies.
PMCID: PMC3392166  PMID: 22892417
knee orthotics; knee pain; rehabilitation
8.  Work disability benefits due to musculoskeletal disorders among Brazilian private sector workers 
BMJ Open  2011;1(1):e000003.
Objective
To evaluate the prevalence and characteristics of disability benefits due to musculoskeletal disorders (MSD) granted to Brazilian private sector workers.
Methods
This was a population-based epidemiological study of MSD-related benefits among registered private sector workers (n=32 959 329). The prevalence (benefits/10 000 workers/year) of work disability benefits was calculated by gender, age, state, Human Development Index (HDI), economic activity, MSD type and work-relatedness.
Results
The prevalence of MSD-related benefits in Brazil among registered private sector workers in 2008 was 93.6/10 000 workers. The prevalence increased with age, and was higher for women (112.2) than for men (88.1), although the former had shorter benefit duration. The gender-adjusted prevalence by state varied from 16.6 to 90.3 for non-work-related, and from 7.8 to 59.6 for work-related benefits. The Brazilian states with a high–very high HDI had the highest prevalence. The top four most common types of MSD-related benefits were due to back pain, intervertebral disc disorders, sinovitis/tenosynovitis and shoulder disorders.
Conclusion
MSD is a frequent cause of work disability in Brazil. There were differences in prevalence among economic activities and between states grouped by HDI. This study demonstrates that further evaluation of the contributing factors associated with MSD-related disability benefits is required. Factors that should be considered include production processes, political organisation, socioeconomic and educational characteristics, the compensation and recording systems, and employee–employer power relationships. These factors may play an important role in the prevalence of MSD-related disability benefits, especially in countries with large socioeconomic iniquities such as Brazil.
Article summary
Article focus
Musculoskeletal disorders (MSD) are a major cause of disability worldwide.
The prevalence and distribution of MSD among Brazilian workers are not well known.
This article evaluates the prevalence and characteristics of disability benefits due to MSD granted to Brazilian private sector workers.
Key messages
The prevalence of MSD-related benefits among registered Brazilian private sector workers in 2008 was 93.6/10 000 workers, with the top four most common benefits being due to back pain, intervertebral disc disorders, sinovitis/tenosynovitis and shoulder disorders.
This study demonstrates that further evaluation of the contributing factors associated with MSD-related disability benefits is required and should assess the production processes, political organisation, socioeconomic and educational characteristics, the compensation and recording systems, and employee–employer power relationships.
These factors may play an important role in the prevalence of MSD-related disability benefits, especially in countries with large socioeconomic iniquities such as Brazil.
Strengths and limitations of this study
All employed workers with a registered job in the private sector were analysed (32 959 329 workers). Prevalence was adjusted by gender, age and category of benefit (work-related or non-work-related). This initial descriptive study provides some baseline data on the magnitude of the problem. The data may be used for future comparisons and to evaluate the effectiveness of prevention programs. The strength of this paper is that it supplies information which could be useful in the implementation of an occupational health policy to reduce MSD. One of the limitations is that it only includes data from registered workers although there are many non-registered workers in Brazil. Another limitation is that this study depends on the quality of the data recorded by the National Insurer (NI) of the Brazilian Ministry of Social Insurance.
doi:10.1136/bmjopen-2011-000003
PMCID: PMC3191405  PMID: 22021719
9.  Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation 
Annals of the Rheumatic Diseases  1998;57(11):649-655.
BACKGROUND—Epidemiologically-based rheumatology healthcare needs assessment requires an understanding of the incidence and prevalence of musculoskeletal disorders in the community, of the reasons why people consult in primary care, and of the proportion of people who would benefit from referral to secondary care and paramedical services. This paper reports the first phase of such a needs assessment exercise.
SPECIFIC OBJECTIVE—To estimate the relative frequency of musculoskeletal pain in different, and multiple, anatomical sites in the adult population.
SETTING—Three general practices in the former Tameside and Glossop Health Authority, Greater Manchester, UK, a predominantly urban area.
DESIGN—Population survey.
METHODS—An age and sex stratified sample of 6000 adults from the three practices was mailed a questionnaire that sought data on demographic factors, musculoskeletal symptoms (pain in the past month lasting for more than a week), and physical disability (using the modified Health Assessment Questionnaire- mHAQ). The areas of pain covered were neck, back, shoulder, elbow, hand, hip, knee, and multiple joints. The Carstairs index was used as a measure of social deprivation of the postcode sector in which the person lived.
RESULTS—The response rate after two reminders was 78.5%. Non-responders were more likely to live in areas of high social deprivation. People who lived in more deprived areas were also more likely to report musculoskeletal pain, especially backpain. After adjusting for social deprivation the rates of musculoskeletal pain did not differ between the practices and so their results were combined. After adjustment for social deprivation, the most common site of pain was back (23%; 95% CI 21, 25) followed by knee (19%; 95% CI 18, 21), and shoulder (16%; 95% CI 14, 17). The majority of subjects who reported pain had pain in more than one site. The prevalence of physical disability in the community rose with age. It was highest in those with multiple joint problems but was also high in those with isolated back or knee pain.
CONCLUSION—Musculoskeletal pain is common in the community. People who live in socially deprived areas have more musculoskeletal symptoms. Estimates of the overall burden of musculoskeletal pain that combine the results of site specific surveys will be too high, those that do not adjust for socioeconomic factors will be too low.

 Keywords: prevalence; pain; social deprivation
PMCID: PMC1752494  PMID: 9924205
10.  Benchmarking the burden of 100 diseases: results of a nationwide representative survey within general practices 
BMJ Open  2011;1(2):e000215.
Objective
To assess the burden of diseases and quality of life (QOL) of patients for a large variety of diseases within general practice.
Design
In a representative nationwide cross-sectional study, a total of 825 general practitioners (GPs) were randomly selected from across France. Independent investigators recruited 8559 patients attending the GPs' practices. Data on QOL (12-Item Short Form questionnaire) and other individual characteristics were documented by the independent investigators for all participants in the waiting room. Medical information was recorded by GPs. Sampling was calibrated to national standards using the CALMAR (CALage sur MARges) weighting procedure. Associations of lower scores (ie, below vs above the first quartile) of physical and mental component scores (physical component summary score (PCS) and mental component summary score (MCS), respectively) with main diseases and patients characteristics were estimated using multivariate logistic regression. Weighted morbidity rates, PCS and MCS were computed for 100 diagnoses using the International Classification of Diseases (9th version).
Results
Overall mental impairment was observed among patients in primary care with an average MCS of 41.5 (SD 8.6), ranging from 33.0 for depressive disorders to 45.3 for patients exhibiting fractures or sprains. Musculoskeletal diseases were found to have the most pronounced effect on impaired physical health (OR=2.31; 95% CI 2.08 to 2.57) with the lowest PCS (45.6 (SD 8.8)) and ranked first (29.0%) among main diagnoses experienced by patients followed by cardiovascular diseases (26.7%) and psychological disorders (22.0%). When combining both prevalence and QOL, musculoskeletal diseases represented the heaviest burden in general practice.
Conclusions
Etude épidémiologique de l'Impact de santé public sur 3 groupes de pathologies (EPI3) is the first study to provide reference figures for burden of disease in general practice across a wide range of morbidities, particularly valuable for health-economics and healthcare-system evaluation.
Article summary
Article focus
The impact of diseases on quality of life (QOL) in general practice has been assessed among selected samples of patients, usually from studies including a limited number of medical practices and/or focusing mainly on chronic conditions.
There is a clear need for more data on QOL of patients in primary care; the aim of the Etude épidémiologique de l'Impact de santé public sur 3 groupes de pathologies (EPI3) survey was to provide reference figures for disease burden in this setting.
Key messages
The EPI3 study was a cross-sectional survey combining unique data from patients and general practitioners (GPs), and allowed provision of reference figures for the vast majority of diseases encountered in primary care for a large number of patients.
The study highlighted the burden of musculoskeletal and psychological disorders, experienced by more than half the patients.
Although social and medical determinants of patients' QOL were somewhat similar than those found in previous studies in primary care, the EPI3 survey showed more pronounced mental impairment in French patients.
Strengths and limitations of this study
No nationwide study on burden of disease combining both prevalence measures and QOL assessment has been conducted to date, addressing such a large variety of diseases in general practice.
On-site selection and recruitment by an independent investigator limited the possibility of selection bias among patients, and the participation of physicians added high specificity to medical data collection.
A study design providing a high specificity in data collection led to a relatively low response rate from GPs. However, stratified recruitment phases and sample sizes from both GPs and patients highly representative of national standards ensured the strong external validity of the results.
Home consultations, which are common among GPs in France, were not surveyed which could have led to an underestimation of the burden of disease.
doi:10.1136/bmjopen-2011-000215
PMCID: PMC3221295  PMID: 22102638
11.  Topical NSAIDs for chronic musculoskeletal pain in adults 
Background
Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly taken orally, but they are also available in topical preparations to be applied to or rubbed onto the skin of a painful joint, typically one affected by arthritis, with the aim of relieving pain locally. Topical NSAIDs are widely used in some parts of the world for acute and chronic painful conditions, but have not been universally accepted until recently. One of the problems has been that older clinical studies were generally short, lasting four weeks or less, and short duration studies are not regarded as adequate in ongoing painful conditions.
Objectives
To examine the use of topical NSAIDs in chronic musculoskeletal pain, focusing on studies of high methodological quality, and examining the measured effect of the preparations according to study duration. The principal aim was to estimate treatment efficacy in longer duration studies of at least 8 weeks.
Search methods
A series of electronic searches, together with bibliographic searches, and searches of in-house databases were combined with electronic searches of clinical trial registers and manufacturers of topical NSAIDs, or companies known to be actively researching topical NSAIDs. There had to be at least 10 participants in each treatment arm, with application of treatment at least once daily.
Selection criteria
Randomised, double blind studies with placebo or active comparators, where at least one treatment was a topical NSAID product, in any topical formulation (cream, gel, patch, solution), in studies lasting at least two weeks.
Data collection and analysis
Two review authors independently assessed study quality and validity, and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk (RR) and numbers needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment.
Main results
Information was available from 7688 participants in 34 studies from 32 publications; 23 studies compared a topical NSAID with placebo. Topical NSAIDs were significantly more effective than placebo for reducing pain due to chronic musculoskeletal conditions. The best data were for topical diclofenac in osteoarthritis, where the NNT for at least 50% pain relief over 8 to 12 weeks compared with placebo was 6.4 for the solution, and 11 for the gel formulation. There were too few data of good quality to calculate NNTs for other individual topical NSAIDs compared with placebo. Direct comparison of topical NSAID with an oral NSAID did not show any difference in efficacy. There was an increase in local adverse events (mostly mild skin reactions) with topical NSAIDs compared with placebo or oral NSAIDs, but no increase in serious adverse events. Gastrointestinal adverse events with topical NSAID did not differ from placebo, but were less frequent than with oral NSAIDs.
A substantial amount of data from unpublished studies was unavailable. Much of this probably relates to formulations that have never been marketed.
Authors’ conclusions
Topical NSAIDs can provide good levels of pain relief; topical diclofenac solution is equivalent to that of oral NSAIDs in knee and hand osteoarthritis, but there is no evidence for other chronic painful conditions. Formulation can influence efficacy. The incidence of local adverse events is increased with topical NSAIDs, but gastrointestinal adverse events are reduced compared with oral NSAIDs.
doi:10.1002/14651858.CD007400.pub2
PMCID: PMC4160008  PMID: 22972108
Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal [* administration & dosage; adverse effects]; Chronic Pain [* drug therapy]; Diclofenac [administration & dosage; adverse effects]; Musculoskeletal Pain [* drug therapy]; Randomized Controlled Trials as Topic; Adult; Humans
12.  Arthroscopic Lavage and Debridement for Osteoarthritis of the Knee 
Executive Summary
Objective
The purpose of this review was to determine the effectiveness and adverse effects of arthroscopic lavage and debridement, with or without lavage, in the treatment of symptoms of osteoarthritis (OA) of the knee, and to conduct an economic analysis if evidence for effectiveness can be established.
Questions Asked
Does arthroscopic lavage improve motor function and pain associated with OA of the knee?
Does arthroscopic debridement improve motor function and pain associated with OA of the knee?
If evidence for effectiveness can be established, what is the duration of effect?
What are the adverse effects of these procedures?
What are the economic considerations if evidence for effectiveness can be established?
Clinical Need
Osteoarthritis, the most common rheumatologic musculoskeletal disorder, affects about 10% of the Canadian adult population. Although the natural history of OA is not known, it is a degenerative condition that affects the bone cartilage in the joint. It can be diagnosed at earlier ages, particularly within the sports injuries population, though the prevalence of non-injury-related OA increases with increasing age and varies with gender, with women being twice as likely as men to be diagnosed with this condition. Thus, with an aging population, the impact of OA on the health care system is expected to be considerable.
Treatments for OA of the knee include conservative or nonpharmacological therapy, like physiotherapy, weight management and exercise; and more generally, intra-articular injections, arthroscopic surgery and knee replacement surgery. Whereas knee replacement surgery is considered an end-of-line intervention, the less invasive surgical procedures of lavage or debridement may be recommended for earlier and more severe disease. Both arthroscopic lavage and debridement are generally indicated in patients with knee joint pain, with or without mechanical problems, that are refractory to medical therapy. The clinical utility of these procedures is unclear, hence, the assessment of their effectiveness in this review.
Lavage and Debridement
Arthroscopic lavage involves the visually guided introduction of saline solution into the knee joint and removal of fluid, with the intent of extracting any excess fluids and loose bodies that may be in the knee joint. Debridement, in comparison, may include the introduction of saline into the joint, in addition to the smoothening of bone surface without any further intervention (less invasive forms of debridement), or the addition of more invasive procedures such as abrasion, partial or full meniscectomy, synovectomy, or osteotomy (referred to as debridement in combination with meniscectomy or other procedures). The focus of this health technology assessment is on the effectiveness of lavage, and debridement (with or without meniscal tear resection).
Review Strategy
The Medical Advisory Secretariat followed its standard procedures and searched these electronic databases: Ovid MEDLINE, EMBASE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and The International Network of Agencies for Health Technology Assessment.
The keywords searched were: arthroscopy, debridement, lavage, wound irrigation, or curettage; arthritis, rheumatoid, osteoarthritis; osteoarthritis, knee; knee or knee joint.
Time frame: Only 2 previous health technology assessments were identified, one of which was an update of the other, and included 3 of 4 randomized controlled trials (RCTs) from the first report. Therefore, the search period for inclusion of studies in this assessment was January 1, 1995 to April 24, 2005.
Excluded were: case reports, comments, editorials, and letters. Identified were 335 references, including previously published health technology assessments, and 5 articles located through a manual search of references from published articles and health technology assessments. These were examined against the criteria, as described below, which resulted in the inclusion of 1 health technology assessment and its corresponding update, and 4 articles (2 RCTs and 2 level 4 studies) for arthroscopic lavage and 8 papers (2 RCTs and 6 level 4 studies) for arthroscopic debridement.
Inclusion Criteria
English-language articles from PubMed, EMBASE, Cochrane Systematic Reviews, and health technology assessments from January 1, 1995 onward
Studies on OA of the knee with a focus on the outcomes of motor function and pain
Studies of arthroscopic procedures only
Studies in which meniscal tear resection/meniscectomy (partial or full) has been conducted in conjunction with lavage or debridement.
Exclusion Criteria
Studies that focus on inflammatory OA, joint tuberculosis, septic joints, psoriatic joints (e.g., psoriatic knee joint synovitis), synovitis, chondropathy of the knee and gonarthrosis (which includes varotic gonarthrosis)
Studies that focus on rheumatoid arthritis
Studies that focus on meniscal tears from an acute injury (e.g., sports injury)
Studies that are based on lavage or debridement for microfracture of the knee
Studies in which other surgical procedures (e.g., high tibial osteotomy, synovectomy, have been conducted in addition to lavage/debridement)
Studies based on malalignment of the knee (e.g., varus/valgus arthritic conditions).
Studies that compare lavage to lavage plus drug therapy
Studies on procedures that are not arthroscopic (i.e., visually guided) (e.g., nonarthroscopic lavage)
Studies of OA in children.
Intervention
Arthroscopic lavage or debridement, with or without meniscectomy, for the treatment of motor function symptoms and pain associated with OA of the knee.
Comparators
Studies in which there was a comparison group of either diseased or healthy subjects or one in which subjects were their own control were included. Comparisons to other treatments included placebo (or sham) arthroscopy. Sham arthroscopy involved making small incisions and manipulating the knee, without the insertion of instruments.
Summary of Findings
In early OA of the knee with pain refractory to medical treatment, there is level 1b evidence that:
Arthroscopic lavage gives rise to a statistically significant, but not clinically meaningful effect in improving pain (WOMAC pain and VAS pain) up to 12 months following surgery. The effect on joint function (WOMAC function) and the primary outcome (WOMAC aggregate) was neither statistically nor clinically significant.
In moderate or severe OA of the knee with pain refractory to medical treatment, there is:
Level 1b evidence that the effect on pain and function of arthroscopic lavage (10 L saline) and debridement (with 10 L saline lavage) is not statistically significant up to 24 months following surgery.
Level 2 evidence that arthroscopic debridement (with 3 L saline lavage) is effective in the control of pain in severe OA of the medial femoral condyle for up to 5 years.
For debridement in combination with meniscectomy, there is level 4 evidence that the procedure, as appropriate, might be effective in earlier stages, unicompartmental disease, shorter symptom duration, sudden onset of mechanical symptoms, and preoperative full range of motion. However, as these findings are derived from very poor quality evidence, the identification of subsets of patients that may benefit from this procedure requires further testing.
In patients with pain due to a meniscal tear, of the medial compartment in particular, repair of the meniscus results in better pain control at 2 years following surgery than if the pain is attributable to other causes. There is insufficient evidence to comment on the effectiveness of lateral meniscus repair on pain control.
Conclusions
Arthroscopic debridement of the knee has thus far only been found to be effective for medial compartmental OA. All other indications should be reviewed with a view to reducing arthroscopic debridement as an effective therapy.
Arthroscopic lavage of the knee is not indicated for any stage of OA.
There is very poor quality evidence on the effectiveness of debridement with partial meniscectomy in the case of meniscal tears in OA of the knee.
PMCID: PMC3382413  PMID: 23074463
13.  The prevalence and incidence of musculoskeletal symptoms among hospital physicians: a systematic review 
Objective
Physicians are exposed to a range of work-related risk factors that may result in occupational diseases. This systematic review aims at shedding light on the prevalence and incidence of musculoskeletal complaints among hospital physicians.
Methods
A systematic literature search was performed in Pubmed and EMBASE (1990–2010), and methodological quality criteria were applied. A search was done for musculoskeletal complaints.
Results
Five medium-quality studies and three high-quality studies were included in this review. The definitions and assessment used in the studies for musculoskeletal complaints were different. In short, the frequently reported prevalence for hand and wrist pain was 8–33 and 0%, 17% for shoulder pain, and 9–28% for neck pain. Moreover, the annual prevalence of low back pain was between 33 and 68%.
Interpretation
The limited number of studies makes it difficult to draw conclusions, and the results should be intepreted with care. In conclusion, musculoskeletal complaints may be work-related complaints in hospital physicians, which need future attention.
doi:10.1007/s00420-010-0565-8
PMCID: PMC3020318  PMID: 20686782
Hospital; Physicians; Musculoskeletal complaints
14.  Endovascular Laser Therapy for Varicose Veins 
Executive Summary
Objective
The objective of the MAS evidence review was to conduct a systematic review of the available evidence on the safety, effectiveness, durability and cost–effectiveness of endovascular laser therapy (ELT) for the treatment of primary symptomatic varicose veins (VV).
Background
The Ontario Health Technology Advisory Committee (OHTAC) met on November 27, 2009 to review the safety, effectiveness, durability and cost-effectiveness of ELT for the treatment of primary VV based on an evidence-based review by the Medical Advisory Secretariat (MAS).
Clinical Condition
VV are tortuous, twisted, or elongated veins. This can be due to existing (inherited) valve dysfunction or decreased vein elasticity (primary venous reflux) or valve damage from prior thrombotic events (secondary venous reflux). The end result is pooling of blood in the veins, increased venous pressure and subsequent vein enlargement. As a result of high venous pressure, branch vessels balloon out leading to varicosities (varicose veins).
Symptoms typically affect the lower extremities and include (but are not limited to): aching, swelling, throbbing, night cramps, restless legs, leg fatigue, itching and burning. Left untreated, venous reflux tends to be progressive, often leading to chronic venous insufficiency (CVI).
A number of complications are associated with untreated venous reflux: including superficial thrombophlebitis as well as variceal rupture and haemorrhage. CVI often results in chronic skin changes referred to as stasis dermatitis. Stasis dermatitis is comprised of a spectrum of cutaneous abnormalities including edema, hyperpigmentation, eczema, lipodermatosclerosis and stasis ulceration. Ulceration represents the disease end point for severe CVI.
CVI is associated with a reduced quality of life particularly in relation to pain, physical function and mobility. In severe cases, VV with ulcers, QOL has been rated to be as bad or worse as other chronic diseases such as back pain and arthritis.
Lower limb VV is a common disease affecting adults and estimated to be the seventh most common reason for physician referral in the US. There is a strong familial predisposition to VV with the risk in offspring being 90% if both parents affected, 20% when neither is affected, and 45% (25% boys, 62% girls) if one parent is affected. Globally, the prevalence of VV ranges from 5% to 15% among men and 3% to 29% among women varying by the age, gender and ethnicity of the study population, survey methods and disease definition and measurement. The annual incidence of VV estimated from the Framingham Study was reported to be 2.6% among women and 1.9% among men and did not vary within the age range (40-89 years) studied.
Approximately 1% of the adult population has a stasis ulcer of venous origin at any one time with 4% at risk. The majority of leg ulcer patients are elderly with simple superficial vein reflux. Stasis ulcers are often lengthy medical problems and can last for several years and, despite effective compression therapy and multilayer bandaging are associated with high recurrence rates. Recent trials involving surgical treatment of superficial vein reflux have resulted in healing and significantly reduced recurrence rates.
Endovascular Laser Therapy for VV
ELT is an image-guided, minimally invasive treatment alternative to surgical stripping of superficial venous reflux. It does not require an operating room or general anesthesia and has been performed in outpatient settings by a variety of medical specialties including surgeons (vascular or general), interventional radiologists and phlebologists. Rather than surgically removing the vein, ELT works by destroying, cauterizing or ablating the refluxing vein segment using heat energy delivered via laser fibre.
Prior to ELT, colour-flow Doppler ultrasonography is used to confirm and map all areas of venous reflux to devise a safe and effective treatment plan. The ELT procedure involves the introduction of a guide wire into the target vein under ultrasound guidance followed by the insertion of an introducer sheath through which an optical fibre carrying the laser energy is advanced. A tumescent anesthetic solution is injected into the soft tissue surrounding the target vein along its entire length. This serves to anaesthetize the vein so that the patient feels no discomfort during the procedure. It also serves to insulate the heat from damaging adjacent structures, including nerves and skin. Once satisfactory positioning has been confirmed with ultrasound, the laser is activated. Both the laser fibre and the sheath are simultaneously, slowly and continuously pulled back along the length of the target vessel. At the end of the procedure, homeostasis is then achieved by applying pressure to the entry point.
Adequate and proper compression stockings and bandages are applied after the procedure to reduce the risk of venous thromboembolism, and to reduce postoperative bruising and tenderness. Patients are encouraged to walk immediately after the procedure and most patients return to work or usual activity within a few days. Follow-up protocols vary, with most patients returning 1-3 weeks later for an initial follow-up visit. At this point, the initial clinical result is assessed and occlusion of the treated vessels is confirmed with ultrasound. Patients often have a second follow-up visit 1-3 months following ELT at which time clinical evaluation and ultrasound are repeated. If required, sclerotherapy may be performed during the ELT procedure or at any follow-up visits.
Regulatory Status
Endovascular laser for the treatment of VV was approved by Health Canada as a class 3 device in 2002. The treatment has been an insured service in Saskatchewan since 2007 and is the only province to insure ELT. Although the treatment is not an insured service in Ontario, it has been provided by various medical specialties since 2002 in over 20 private clinics.
Methods
Literature Search
The MAS evidence-based review was performed as an update to the 2007 health technology review performed by the Australian Medical Services Committee (MSAC) to support public financing decisions. The literature search was performed on August 18, 2009 using standard bibliographic databases for studies published from January 1, 2007 to August 15, 2009. Search alerts were generated and reviewed for additional relevant literature up until October 1, 2009.
Inclusion Criteria
English language full-reports and human studies
Original reports with defined study methodology
Reports including standardized measurements on outcome events such as technical success, safety, effectiveness, durability, quality of life or patient satisfaction
Reports involving ELT for VV (great or small saphenous veins)
Randomized controlled trials (RCTs), systematic reviews and meta-analyses
Cohort and controlled clinical studies involving > 1 month ultrasound imaging follow-up
Exclusion Criteria
Non systematic reviews, letters, comments and editorials
Reports not involving outcome events such as safety, effectiveness, durability, or patient satisfaction following an intervention with ELT
Reports not involving interventions with ELT for VV
Pilot studies or studies with small samples ( < 50 subjects)
Summary of Findings
The MAS evidence search identified 14 systematic reviews, 29 cohort studies on safety and effectiveness, four cost studies and 12 randomized controlled trials involving ELT, six of these comparing endovascular laser with surgical ligation and saphenous vein stripping.
Since 2007, 22 cohort studies involving 10,883 patients undergoing ELT of the great saphenous vein (GSV) have been published. Imaging defined treatment effectiveness of mean vein closure rates were reported to be greater than 90% (range 93%- 99%) at short term follow-up. Longer than one year follow-up was reported in five studies with life table analysis performed in four but the follow up was still limited at three and four years. The overall pooled major adverse event rate, including DVT, PE, skin burns or nerve damage events extracted from these studies, was 0.63% (69/10,883).
The overall level of evidence of randomized trials comparing ELT with surgical ligation and vein stripping (n= 6) was graded as moderate to high. Recovery after treatment was significantly quicker after ELT (return to work median number of days, 4 vs. 17; p= .005). Major adverse events occurring after surgery were higher [(1.8% (n=4) vs. 0.4% (n = 1) 1 but not significantly. Treatment effectiveness as measured by imaging vein absence or closure, symptom relief or quality of life similar in the two treatment groups and both treatments resulted in statistically significantly improvements in these outcomes. Recurrence was low after both treatments at follow up but neovascularization (growth of new vessels, a key predictor of long term recurrence was significantly more common (18% vs. 1%; p = .001) after surgery. Although patient satisfaction was reported to be high (>80%) with both treatments, patient preferences evaluated through recruitment process, physician reports and consumer groups were strongly in favour of ELT. For patients minimal complications, quick recovery and dependability of outpatient scheduling were key considerations.
As clinical effectiveness of the two treatments was similar, a cost-analysis was performed to compare differences in resources and costs between the two procedures. A budget impact analysis for introducing ELT as an insured service was also performed. The average case cost (based on Ontario hospital costs and medical resources) for surgical vein stripping was estimated to be $1,799. Because of the uncertainties with resources associated with ELT, in addition to the device related costs, hospital costs were varied and assumed to be the same as or less than (40%) those for surgery resulting in an average ELT case cost of $2,025 or $1,602.
Based on the historical pattern of surgical vein stripping for varices a 5-year projection was made for annual volumes and costs. In Ontario in 2007/2008, 3481 surgical vein stripping procedures were performed, 28% for repeat procedures. Annual volumes of ELT currently being performed in the province in over 20 private clinics were estimated to be approximately 840. If ELT were publicly reimbursed, it was assumed that it would capture 35% of the vein stripping market in the first year and increase to 55% in subsequent years. Based on these assumptions if ELT were not publicly reimbursed, the province would be paying approximately $5.9 million and if ELT were reimbursed the province would pay $8.2 million if the hospital costs for ELT were the same as surgery and $7.1 million if the hospital costs were less (40%) than surgery.
The conclusions on the comparative outcomes between laser ablation and surgical ligation and saphenous vein stripping are summarized in the table below (ES Table 1).
Outcome comparisons of ELT vs. surgery for VV
The outcomes of the evidence-based review on these treatments based on three different perspectives are summarized below:
Patient Outcomes – ELT vs. Surgery
ELT has a quicker recovery attributable to the decreased pain, lower minor complications, use of local anesthesia with immediate ambulation.
ELT is as effective as surgery in the short term as assessed by imaging anatomic outcomes, symptomatic relief and HRQOL outcomes.
Recurrence is similar but neovascularization, a key predictor of long term recurrence, is significantly higher with surgery.
Patient satisfaction is equally high after both treatments but patient preference is much more strongly for ELT. Surgeons performing ELT are satisfied with treatment outcomes and regularly offer ELT as a treatment alternative to surgery.
Clinical or Technical Advantages – ELT Over Surgery
An endovascular approach can more easily and more precisely treat multilevel disease and difficult to treat areas
ELT is an effective and a less invasive treatment for the elderly with VV and those with venous leg ulcers.
System Outcomes – ELT Replacing Surgery
ELT may offer system advantages in that the treatment can be offered by several medical specialties in outpatient settings and because it does not require an operating theatre or general anesthesia.
The treatment may result in ↓ pre-surgical investigations, decanting of patients from OR, ↓ demand on anesthetists time, ↓ hospital stay, ↓decrease wait time for VV treatment and provide more reliable outpatient scheduling.
Depending on the reimbursement mechanism for the treatment, however, it may also result in closure of outpatient clinics with an increasingly centralization of procedures in selected hospitals with large capital budgets resulting in larger and longer waiting lists.
Procedure costs may be similar for the two treatments but the budget impact may be greater with insurance of ELT because of the transfer of the cases from the private market to the public payer system.
PMCID: PMC3377531  PMID: 23074409
15.  Musculoskeletal pain and effort-reward imbalance- a systematic review 
BMC Public Health  2014;14:37.
Background
Musculoskeletal pain may be triggered by physical strains and psychosocial risk factors. The effort-reward imbalance model (ERI model) is a stress model which measures psychosocial factors in the working world. The question is whether workers with an effort-reward imbalance report musculoskeletal pain more frequently than those with no effort-reward imbalance. A systematic review using a best evidence synthesis approach was conducted to answer this question.
Methods
A literature search was conducted for the period from 1996 to 2012, using three databases (Pubmed, Embase and PsycINFO). The research criteria related to psychosocial, work-related stress as per the ERI model and to musculoskeletal pain. A quality score was developed using various quality criteria to assess the standard of the studies. The level of evidence was graded as in (Am J Ind Med 39:180–193, 2001).
Results
After applying the inclusion criteria, a total of 19 studies were included in the review: 15 cross-sectional studies, three prospective studies and one case–control study. 74% of all studies exhibited good methodological quality, 53% collected data using the original ERI questionnaire, and in 42% of the studies, there was adequate control for physical working conditions. Furthermore, different cut-off points were used to classify exposed and non-exposed individuals. On the basis of 13 studies with a positive, statistically significant association, a moderate level of evidence was inferred for the association between effort-reward imbalance and musculoskeletal pain. The evidence for a role of over-commitment and for its interaction with effort-reward imbalance was rated as inconclusive - on the basis of eight and five studies, respectively.
Conclusions
On the basis of the available evidence, no reliable conclusion may be drawn about any association between the psychosocial factors ascertained using the ERI model and musculoskeletal pain. Before a reliable statement can be made on the association between ERI and musculoskeletal pain, additional longitudinal studies must be performed - with a standardised method for recording and classifying exposure, as well as control of physical confounders. Appropriate preventive measures can then be specified.
doi:10.1186/1471-2458-14-37
PMCID: PMC3898401  PMID: 24428955
Effort-reward imbalance; Musculoskeletal pain; Psychosocial work stress; Review
16.  Endovascular Radiofrequency Ablation for Varicose Veins 
Executive Summary
Objective
The objective of the MAS evidence review was to conduct a systematic review of the available evidence on the safety, effectiveness, durability and cost–effectiveness of endovascular radiofrequency ablation (RFA) for the treatment of primary symptomatic varicose veins.
Background
The Ontario Health Technology Advisory Committee (OHTAC) met on August 26th, 2010 to review the safety, effectiveness, durability, and cost-effectiveness of RFA for the treatment of primary symptomatic varicose veins based on an evidence-based review by the Medical Advisory Secretariat (MAS).
Clinical Condition
Varicose veins (VV) are tortuous, twisted, or elongated veins. This can be due to existing (inherited) valve dysfunction or decreased vein elasticity (primary venous reflux) or valve damage from prior thrombotic events (secondary venous reflux). The end result is pooling of blood in the veins, increased venous pressure and subsequent vein enlargement. As a result of high venous pressure, branch vessels balloon out leading to varicosities (varicose veins).
Symptoms typically affect the lower extremities and include (but are not limited to): aching, swelling, throbbing, night cramps, restless legs, leg fatigue, itching and burning. Left untreated, venous reflux tends to be progressive, often leading to chronic venous insufficiency (CVI). A number of complications are associated with untreated venous reflux: including superficial thrombophlebitis as well as variceal rupture and haemorrhage. CVI often results in chronic skin changes referred to as stasis dermatitis. Stasis dermatitis is comprised of a spectrum of cutaneous abnormalities including edema, hyperpigmentation, eczema, lipodermatosclerosis and stasis ulceration. Ulceration represents the disease end point for severe CVI. CVI is associated with a reduced quality of life particularly in relation to pain, physical function and mobility. In severe cases, VV with ulcers, QOL has been rated to be as bad or worse as other chronic diseases such as back pain and arthritis.
Lower limb VV is a very common disease affecting adults – estimated to be the 7th most common reason for physician referral in the US. There is a very strong familial predisposition to VV. The risk in offspring is 90% if both parents affected, 20% when neither affected and 45% (25% boys, 62% girls) if one parent affected. The prevalence of VV worldwide ranges from 5% to 15% among men and 3% to 29% among women varying by the age, gender and ethnicity of the study population, survey methods and disease definition and measurement. The annual incidence of VV estimated from the Framingham Study was reported to be 2.6% among women and 1.9% among men and did not vary within the age range (40-89 years) studied.
Approximately 1% of the adult population has a stasis ulcer of venous origin at any one time with 4% at risk. The majority of leg ulcer patients are elderly with simple superficial vein reflux. Stasis ulcers are often lengthy medical problems and can last for several years and, despite effective compression therapy and multilayer bandaging are associated with high recurrence rates. Recent trials involving surgical treatment of superficial vein reflux have resulted in healing and significantly reduced recurrence rates.
Endovascular Radiofrequency Ablation for Varicose Veins
RFA is an image-guided minimally invasive treatment alternative to surgical stripping of superficial venous reflux. RFA does not require an operating room or general anaesthesia and has been performed in an outpatient setting by a variety of medical specialties including surgeons and interventional radiologists. Rather than surgically removing the vein, RFA works by destroying or ablating the refluxing vein segment using thermal energy delivered through a radiofrequency catheter.
Prior to performing RFA, color-flow Doppler ultrasonography is used to confirm and map all areas of venous reflux to devise a safe and effective treatment plan. The RFA procedure involves the introduction of a guide wire into the target vein under ultrasound guidance followed by the insertion of an introducer sheath through which the RFA catheter is advanced. Once satisfactory positioning has been confirmed with ultrasound, a tumescent anaesthetic solution is injected into the soft tissue surrounding the target vein along its entire length. This serves to anaesthetize the vein, insulate the heat from damaging adjacent structures, including nerves and skin and compresses the vein increasing optimal contact of the vessel wall with the electrodes or expanded prongs of the RF device. The RF generator is then activated and the catheter is slowly pulled along the length of the vein. At the end of the procedure, hemostasis is then achieved by applying pressure to the vein entry point.
Adequate and proper compression stockings and bandages are applied after the procedure to reduce the risk of venous thromboembolism and to reduce postoperative bruising and tenderness. Patients are encouraged to walk immediately after the procedure. Follow-up protocols vary, with most patients returning 1 to 3 weeks later for an initial follow-up visit. At this point, the initial clinical result is assessed and occlusion of the treated vessels is confirmed with ultrasound. Patients often have a second follow-up visit 1 to 3 months following RFA at which time clinical evaluation and ultrasound are repeated. If required, additional procedures such as phlebectomy or sclerotherapy may be performed during the RFA procedure or at any follow-up visits.
Regulatory Status
The Closure System® radiofrequency generator for endovascular thermal ablation of varicose veins was approved by Health Canada as a class 3 device in March 2005, registered under medical device license 67865. The RFA intravascular catheter was approved by Health Canada in November 2007 for the ClosureFast catheter, registered under medical device license 16574. The Closure System® also has regulatory approvals in Australia, Europe (CE Mark) and the United States (FDA clearance). In Ontario, RFA is not an insured service and is currently being introduced in private clinics.
Methods
Literature Search
The MAS evidence–based review was performed to support public financing decisions. The literature search was performed on March 9th, 2010 using standard bibliographic databases for studies published up until March, 2010.
Inclusion Criteria
English language full-reports and human studies Original reports with defined study methodologyReports including standardized measurements on outcome events such as technical success, safety, effectiveness, durability, quality of life or patient satisfaction Reports involving RFA for varicose veins (great or small saphenous veins)Randomized controlled trials (RCTs), systematic reviews and meta-analysesCohort and controlled clinical studies involving ≥ 1 month ultrasound imaging follow-up
Exclusion Criteria
Non systematic reviews, letters, comments and editorials Reports not involving outcome events such as safety, effectiveness, durability, or patient satisfaction following an intervention with RFAReports not involving interventions with RFA for varicose veinsPilot studies or studies with small samples (< 50 subjects)
Summary of Findings
The MAS evidence search on the safety and effectiveness of endovascular RFA ablation of VV identified the following evidence: three HTAs, nine systematic reviews, eight randomized controlled trials (five comparing RFA to surgery and three comparing RFA to ELT), five controlled clinical trials and fourteen cohort case series (four were multicenter registry studies).
The majority (12⁄14) of the cohort studies (3,664) evaluating RFA for VV involved treatment with first generation RFA catheters and the great saphenous vein (GSV) was the target vessel in all studies. Major adverse events were uncommonly reported and the overall pooled major adverse event rate extracted from the cohort studies was 2.9% (105⁄3,664). Imaging defined treatment effectiveness of vein closure rates were variable ranging from 68% to 96% at post-operative follow-up. Vein ablation rate at 6-month follow-up was reported in four studies with rates close to 90%. Only one study reported vein closure rates at 2 years but only for a minority of the eligible cases. The two studies reporting on RFA ablation with the more efficient second generation catheters involved better follow-up and reported higher ablation rates close to 100% at 6-month follow-up with no major adverse events. A large prospective registry trial that recruited over 1,000 patients at thirty-four largely European centers reported on treatment success in six overlapping reports on selected patient subgroups at various follow-up points up to 5 year. However, the follow-up for eligible recruited patients at all time points was low resulting in inadequate estimates of longer term treatment efficacy.
The overall level of evidence of randomized trials comparing RFA with surgical ligation and vein stripping (n = 5) was graded as low to moderate. In all trials RFA ablation was performed with first generation catheters in the setting of the operating theatre under general anaesthesia, usually without tumescent anaesthesia. Procedure times were significantly longer after RFA than surgery. Recovery after treatment was significantly quicker after RFA both with return to usual activity and return to work with on average a one week less of work loss. Major adverse events occurring after surgery were higher [(1.8% (n=4) vs. 0.4% (n = 1) than after RFA but not significantly. Treatment effectiveness measured by imaging defined vein absence or vein closure was comparable in the two treatment groups. Significant improvements in vein symptoms and quality of life over baseline were reported for both treatment groups. Improvements in these outcomes were significantly greater in the RFA group than the surgery group in the peri-operative period but not in later follow-up. Follow-up in these trials was inadequate to evaluate longer term recurrence for either treatment. Patient satisfaction was reported to be high for both treatments but was higher for RFA.
The studies comparing endovascular treatment approaches for VV (RFA and ELT) were more limited. Three RCT studies compared RFA (two with the second generation catheter) with ELT but mainly focused on peri-procedural outcomes such as pain, complications and recovery. Vein ablation rates were not evaluated in the trials, except for one small trial involving bilateral VV. Pain responses in patients undergoing ablation were extremely variable and up to 2 weeks, mean pain levels were significantly less with RFA than ELT ablation but differences were not significant at one month. Recovery, evaluated as return to usual activity or return to work, however, was similar in the treatment groups. Vein symptom and QOL improvements were improved in both groups but were significantly better in the RFA group than the ELT group at 2 weeks, but not at one month. Vein ablation rates were evaluated in several controlled clinical studies comparing the treatments between centers or within centers between individuals or over time. Comparisons in these studies were inconsistent with vein ablation rates for RFA reported to be similar to, higher than and lower than those with ELT.
Economic Analysis
RFA and surgical vein stripping, the main comparator reimbursed by the public system, are comparable in clinical benefits. Hence a cost-analysis was conducted to identify the differences in resources and costs between both procedures and a budgetary impact analysis (BIA) was conducted to project costs over a 5- year period in the province of Ontario. The target population of this economic analysis was patients with symptomatic varicose veins and the primary analytic perspective was that of the Ministry of Health and Long-Term Care.
The average case cost (based on Ontario hospital costs and medical resources) for surgical vein stripping was estimated to be $1,799. In order to calculate a procedural cost for RFA it was assumed that the hospital cost and physician labour fees, excluding anaesthesia and surgical assistance, were the same as vein stripping surgery. The manufacturer also provided details on the generator with a capital cost of $27,500 and a lifespan of 5 years and the disposables (catheter, sheath, guidewire) with a cost of $673 per case. The average case cost for RFA was therefore estimated to be $1,356. One-way sensitivity analysis was also conducted with hospital cost of RFA varied to 60% that of vein stripping surgery (average cost per case = $627.08) to calculate an impact to the province.
Historical volumes of vein stripping surgeries in Ontario were used to project surgeries in a linear fashion up to five years into the future. Volumes for RFA and ELT were calculated based on share capture from the surgery market based on discussion with clinical expert opinion and existing private data based on discussion with the manufacturer. RFA is expected to compete with ELT and capture some of the market. If ELT is reimbursed by the public sector then numbers will continue to increase from previous private data and share capture from the conventional surgical treatment market. Therefore, RFA cases will also increase since it will be capturing a share of the ELT market. A budget impact to the province was then calculated by multiplying volumes by the cost of the procedure.
RFA is comparable in clinical benefits to vein stripping surgery. It has the extra upfront cost of the generator and cost per case for disposables but does not require an operating theater, anaesthetist or surgical assistant fees. The impact to the province is expected to be 5 M by Year 5 with the introduction of new ELT and RFA image guided endovascular technologies and existing surgery for varicose veins.
Conclusion
The conclusions on the comparative outcomes between endovascular RFA and surgical ligation and saphenous vein stripping and between endovascular RFA and laser ablation for VV treatment are summarized in the table below (ES Table 1).
Outcome comparisons of RFA vs. surgery and RFA vs ELT for varicose veins
ELT refers to endovascular laser ablation; RFA, radiofrequency ablation
The outcomes of the evidence-based review on these treatments for VV based on different perspectives are summarized below:
RFA First versus Second Generation Catheters and Segmental Ablation
Ablation with second generation catheters and segmental ablation offered technical advantages with improved ease and significant decreases in procedure time. RFA ablation with second generation catheters is also no longer restricted to smaller (< 12 mm diameter) saphenous veins. The safety profile with the new device and method of energy delivery is as good as or improved over the first generation device. No major adverse events were reported in two multicenter prospective cohort studies in 6 month follow-up with over 500 patients. Post-operative complications such as bruising and pain were significantly less with RFA ablation with second generation catheters than ELT in two RCT trials.RFA treatment with second generation catheters has ablation rates that are higher than with first generation catheters and are more comparable with the consistently high rates of ELT.
Endovascular RFA versus Surgery
RFA has a quicker recovery attributable to decreased pain and lower minor complications.RFA, in the short term was comparable to surgery in treatment effectiveness as assessed by imaging defined anatomic outcomes such as vein closure, flow or reflux. Other treatment outcomes such as symptomatic relief and HRQOL were significantly improved in both groups and between group differences in the early peri-operative period were likely influenced by pain experiences. Longer term follow-up was inadequate to evaluate recurrence after either treatment.Patient satisfaction was high after both treatments but was higher for RFA than surgery.
Endovascular RFA versus ELT
RFA has significantly less post-operative pain than ELT but differences were not significant when pain was adjusted for analgesic use and pain differences between groups did not persist at 1 month follow-up.Treatment effectiveness, measured as symptom relief and QOL improvement were similar between the endovascular treatments in the short term (within 1 month) Treatment effectiveness measured as imaging defined vein ablation was not measured in any RCT trials (only for bilateral VV disease) and results were inconsistently reported in observational trials.Longer term follow-up was not available to assess recurrence after either treatment.
System Outcomes – RFA Replacing Surgery or Competing with ELT
RFA may offer system advantages in that the treatment can be offered by several medical specialties in outpatient settings and because it does not require an operating theatre or general anaesthesia. The treatment may result in decanting of patients from OR with decreased pre-surgical investigations, demand on anaesthetists’ time, hospital stay and wait time for VV treatment. It may also provide more reliable outpatient scheduling. Procedure costs may be less for endovascular approaches than surgery but the budget impact may be greater with insurance of RFA because of the transfer of cases from the private market to the public payer system.Competition between RFA and ELT endovascular approaches is likely to continue to stimulate innovation and technical changes to advance patient care and result in competitive pricing.
PMCID: PMC3377553  PMID: 23074413
17.  Musculoskeletal pain in overweight and obese children 
This review seeks to provide a current overview of musculoskeletal pain in overweight and obese children. Databases searched were Academic Search Complete, CINAHL, Medline, Proquest Health and Medical Complete, Scopus, Google Scholar, SPORTDiscuss and Trove for studies published between 1 January 2000 and 30 December 2012. We used a broad definition of children within a 3- to 18-year age range. The search strategy included the following terms: obesity, morbid obesity, overweight, pain, musculoskeletal pain, child, adolescent, chronic pain, back pain, lower back pain, knee pain, hip pain, foot pain and pelvic pain. Two authors independently assessed each record, and any disagreement was resolved by the third author. Data were analysed using a narrative thematic approach owing to the heterogeneity of reported outcome measures. Ninety-seven records were initially identified using a variety of terms associated with children, obesity and musculoskeletal pain. Ten studies were included for thematic analysis when predetermined inclusion criteria were applied. Bone deformity and dysfunction, pain reporting and the impact of children being overweight or obese on physical activity, exercise and quality of life were the three themes identified from the literature. Chronic pain, obesity and a reduction in physical functioning and activity may contribute to a cycle of weight gain that affects a child's quality of life. Future studies are required to examine the sequela of overweight and obese children experiencing chronic musculoskeletal pain.
doi:10.1038/ijo.2013.187
PMCID: PMC3884137  PMID: 24077005
adolescent; overweight; pain; musculoskeletal; disability; child health
18.  The Prevalence of low back pain in Africa: a systematic review 
Background
Low back pain (LBP) is the most prevalent musculoskeletal condition and one the most common causes of disability in the developed nations. Anecdotally, there is a general assumption that LBP prevalence in Africa is comparatively lower than in developed countries. The aim of this review was to systematically appraise the published prevalence studies conducted on the African continent to establish the prevalence of LBP in Africa.
Methods
A comprehensive search was conducted in April 2006. The following databases PEDro, Psychinfo, Science Direct, SportsDiscus, PubMed, CINAHL, Biblioline Pro-African Wide NiPAD and SA ePublications were individually searched using specifically developed search strategies for epidemiological research conducted on LBP amongst the African population. Two reviewers independently evaluated the methodological quality of the studies reviewed.
Results
A total of 27 eligible epidemiological studies were included in this review. The majority of the studies (63%) were conducted in South Africa (37%) and Nigeria (26%). The most common population group involved workers (48%), while scholars comprised 15% of the population. 67% of the studies were found to be methodologically sound, and the LBP prevalence of these were analyzed. The mean LBP point prevalence among the adolescents was 12% and among adults was 32%. The average one year prevalence of LBP among adolescents was 33% and among adults was 50%. The average lifetime prevalence of LBP among the adolescents was 36% and among adults was 62%.
Conclusion
The findings support the global burden of disease of LBP, in addition to suggesting that LBP prevalence among Africans is rising and is of concern. Further research into the most effective strategies to prevent and manage LBP in Africa is warranted.
doi:10.1186/1471-2474-8-105
PMCID: PMC2198912  PMID: 17976240
19.  Whole-Body Vibration and Rehabilitation of Chronic Diseases: A Review of the Literature 
The objectives of the study were to review the current literature and findings on the effects of whole-body vibration (WBV) as a training method on performance and its ability to aid in the rehabilitation of chronic diseases (neurological, musculoskeletal or metabolic conditions). Six electronic databases were searched. The combination of the search terminology used included WBV and several neurological, musculoskeletal and metabolic conditions. Twenty six papers were found to be relevant for this review and were included for critical evaluation with regards to sample characteristics, research intervention and methodology. Most studies were conducted on patients diagnosed with neurological conditions (n = 15) while less were performed on patients suffering from musculoskeletal (n = 7) or metabolic (n = 4) disorders. Comparisons were difficult to draw on because of the different pathologies and the differences in the methodology of each study. Some of the observed methodological flaws included limitations in relation to insufficient randomisation, lack of sample homogeneity (size, age variability) and poor blinding in most studies. No consensus could be reached as to whether WBV is more effective than other interventions or no intervention at all, while the additional effects that WBV may have in relation to other interventions could not be assumed. Nevertheless, chronic WBV training seems to only improve strength in neurological patients while balance and mobility improves only in patients suffering from musculoskeletal or metabolic but not from neurological conditions. Although WBV did not prove to be more effective compared to other training methods, it can be used, in some cases, as a less fatiguing and less time-consuming method to enhance physical capabilities. Future research should focus on the effectiveness of WBV in relation to no treatment at all, and to age.
Key pointsChronic WBV training seems to only improve strength in neurological patients while balance and mobility improves only in patients suffering from musculoskeletal or metabolic conditions.WBV did not prove to be more effective than other interventions, while the positive effects of WBV in relation to no intervention at all could not be established.No consensus could be reached as to which vibration type is more effective.WBV training could be used as a safe, less fatiguing and less time-consuming type of exercise for patients with neurologic conditions instead of other more demanding interventions.
PMCID: PMC3737877  PMID: 24149191
Exercise; neurological; musculoskeletal; metabolic conditions
20.  Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective
The objective of this evidence-based analysis was to determine the effectiveness and cost-effectiveness of multidisciplinary care (MDC) compared with usual care (UC, single health care provider) for the treatment of stable chronic obstructive pulmonary disease (COPD).
Clinical Need: Condition and Target Population
Chronic obstructive pulmonary disease is a progressive disorder with episodes of acute exacerbations associated with significant morbidity and mortality. Cigarette smoking is linked causally to COPD in more than 80% of cases. Chronic obstructive pulmonary disease is among the most common chronic diseases worldwide and has an enormous impact on individuals, families, and societies through reduced quality of life and increased health resource utilization and mortality.
The estimated prevalence of COPD in Ontario in 2007 was 708,743 persons.
Technology
Multidisciplinary care involves professionals from a range of disciplines, working together to deliver comprehensive care that addresses as many of the patient’s health care and psychosocial needs as possible.
Two variables are inherent in the concept of a multidisciplinary team: i) the multidisciplinary components such as an enriched knowledge base and a range of clinical skills and experiences, and ii) the team components, which include but are not limited to, communication and support measures. However, the most effective number of team members and which disciplines should comprise the team for optimal effect is not yet known.
Research Question
What is the effectiveness and cost-effectiveness of MDC compared with UC (single health care provider) for the treatment of stable COPD?
Research Methods
Literature Search
Search Strategy
A literature search was performed on July 19, 2010 using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published from January 1, 1995 until July 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
health technology assessments, systematic reviews, or randomized controlled trials
studies published between January 1995 and July 2010;
COPD study population
studies comparing MDC (2 or more health care disciplines participating in care) compared with UC (single health care provider)
Exclusion Criteria
grey literature
duplicate publications
non-English language publications
study population less than 18 years of age
Outcomes of Interest
hospital admissions
emergency department (ED) visits
mortality
health-related quality of life
lung function
Quality of Evidence
The quality of each included study was assessed, taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses.
The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Findings
Six randomized controlled trials were obtained from the literature search. Four of the 6 studies were completed in the United States. The sample size of the 6 studies ranged from 40 to 743 participants, with a mean study sample between 66 and 71 years of age. Only 2 studies characterized the study sample in terms of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD stage criteria, and in general the description of the study population in the other 4 studies was limited. The mean percent predicted forced expiratory volume in 1 second (% predicted FEV1) among study populations was between 32% and 59%. Using this criterion, 3 studies included persons with severe COPD and 2 with moderate COPD. Information was not available to classify the population in the sixth study.
Four studies had MDC treatment groups which included a physician. All studies except 1 reported a respiratory specialist (i.e., respiratory therapist, specialist nurse, or physician) as part of the multidisciplinary team. The UC group was comprised of a single health care practitioner who may or may not have been a respiratory specialist.
A meta-analysis was completed for 5 of the 7 outcome measures of interest including:
health-related quality of life,
lung function,
all-cause hospitalization,
COPD-specific hospitalization, and
mortality.
There was only 1 study contributing to the outcome of all-cause and COPD-specific ED visits which precluded pooling data for these outcomes. Subgroup analyses were not completed either because heterogeneity was not significant or there were a small number of studies that were meta-analysed for the outcome.
Quality of Life
Three studies reported results of quality of life assessment based on the St. George’s Respiratory Questionnaire (SGRQ). A mean decrease in the SGRQ indicates an improvement in quality of life while a mean increase indicates deterioration in quality of life. In all studies the mean change score from baseline to the end time point in the MDC treatment group showed either an improvement compared with the control group or less deterioration compared with the control group. The mean difference in change scores between MDC and UC groups was statistically significant in all 3 studies. The pooled weighted mean difference in total SGRQ score was −4.05 (95% confidence interval [CI], −6.47 to 1.63; P = 0.001). The GRADE quality of evidence was assessed as low for this outcome.
Lung Function
Two studies reported results of the FEV1 % predicted as a measure of lung function. A negative change from baseline infers deterioration in lung function and a positive change from baseline infers an improvement in lung function. The MDC group showed a statistically significant improvement in lung function up to 12 months compared with the UC group (P = 0.01). However this effect is not maintained at 2-year follow-up (P = 0.24). The pooled weighted mean difference in FEV1 percent predicted was 2.78 (95% CI, −1.82 to −7.37). The GRADE quality of evidence was assessed as very low for this outcome indicating that an estimate of effect is uncertain.
Hospital Admissions
All-Cause
Four studies reported results of all-cause hospital admissions in terms of number of persons with at least 1 admission during the follow-up period. Estimates from these 4 studies were pooled to determine a summary estimate. There is a statistically significant 25% relative risk (RR) reduction in all-cause hospitalizations in the MDC group compared with the UC group (P < 0.001). The index of heterogeneity (I2) value is 0%, indicating no statistical heterogeneity between studies. The GRADE quality of evidence was assessed as moderate for this outcome, indicating that further research may change the estimate of effect.
COPD-Specific Hospitalization
Three studies reported results of COPD-specific hospital admissions in terms of number of persons with at least 1 admission during the follow-up period. Estimates from these 3 studies were pooled to determine a summary estimate. There is a statistically significant 33% RR reduction in all-cause hospitalizations in the MDC group compared with the UC group (P = 0.002). The I2 value is 0%, indicating no statistical heterogeneity between studies. The GRADE quality of evidence was assessed as moderate for this outcome, indicating that further research may change the estimate of effect.
Emergency Department Visits
All-Cause
Two studies reported results of all-cause ED visits in terms of number of persons with at least 1 visit during the follow-up period. There is a statistically nonsignificant reduction in all-cause ED visits when data from these 2 studies are pooled (RR, 0.64; 95% CI, 0.31 to −1.33; P = 0.24). The GRADE quality of evidence was assessed as very low for this outcome indicating that an estimate of effect is uncertain.
COPD-Specific
One study reported results of COPD-specific ED visits in terms of number of persons with at least 1 visit during the follow-up period. There is a statistically significant 41% reduction in COPD-specific ED visits when the data from these 2 studies are pooled (RR, 0.59; 95% CI, 0.43−0.81; P < 0.001). The GRADE quality of evidence was assessed as moderate for this outcome.
Mortality
Three studies reported the mortality during the study follow-up period. Estimates from these 3 studies were pooled to determine a summary estimate. There is a statistically nonsignificant reduction in mortality between treatment groups (RR, 0.81; 95% CI, 0.52−1.27; P = 0.36). The I2 value is 19%, indicating low statistical heterogeneity between studies. All studies had a 12-month follow-up period. The GRADE quality of evidence was assessed as low for this outcome.
Conclusions
Significant effect estimates with moderate quality of evidence were found for all-cause hospitalization, COPD-specific hospitalization, and COPD-specific ED visits (Table ES1). A significant estimate with low quality evidence was found for the outcome of quality of life (Table ES2). All other outcome measures were nonsignificant and supported by low or very low quality of evidence.
Summary of Dichotomous Data
Abbreviations: CI, confidence intervals; COPD, chronic obstructive pulmonary disease; n, number.
Summary of Continuous Data
Abbreviations: CI, confidence intervals; FEV1, forced expiratory volume in 1 second; n, number; SGRQ, St. George’s Respiratory Questionnaire.
PMCID: PMC3384374  PMID: 23074433
21.  Duloxetine versus other anti-depressive agents for depression 
Background
Although pharmacological and psychological interventions are both effective for major depression, in primary and secondary care settings antidepressant drugs remain the mainstay of treatment. Amongst antidepressants many different agents are available. Duloxetine hydrochloride is a dual reuptake inhibitor of serotonin and norepinephrine and has been licensed by the Food and Drug Administration in the US for major depressive disorder (MDD), generalised anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.
Objectives
To assess the evidence for the efficacy, acceptability and tolerability of duloxetine in comparison with all other antidepressant agents in the acute-phase treatment of major depression.
Search methods
MEDLINE (1966 to 2012), EMBASE (1974 to 2012), the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Central Register of Controlled Trials up to March 2012. No language restriction was applied. Reference lists of relevant papers and previous systematic reviews were hand-searched. Pharmaceutical company marketing duloxetine and experts in this field were contacted for supplemental data.
Selection criteria
Randomised controlled trials allocating patients with major depression to duloxetine versus any other antidepressive agent.
Data collection and analysis
Two review authors independently extracted data and a double-entry procedure was employed. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy, acceptability and tolerability.
Main results
A total of 16 randomised controlled trials (overall 5735 participants) were included in this systematic review. Of these, three trials were unpublished. We found 11 studies (overall 3304 participants) comparing duloxetine with one selective serotonin reuptake inhibitor (SSRI) (six studies versus paroxetine, three studies versus escitalopram and two versus fluoxetine), four studies (overall 1978 participants) comparing duloxetine with a newer antidepressants (three with venlafaxine and one with desvenlafaxine, respectively) and one study (overall 453 participants) comparing duloxetine with an antipsychotic drug which is also used as an antidepressive agent, quetiapine. No studies were found comparing duloxetine with tricyclic antidepressants. The pooled confidence intervals were rather wide and there were no statistically significant differences in efficacy when comparing duloxetine with other antidepressants. However, when compared with escitalopram or venlafaxine, there was a higher rate of drop out due to any cause in the patients randomised to duloxetine (odds ratio (OR) 1.62; 95% confidence interval (CI) 1.01 to 2.62 and OR 1.56; 95% CI 1.14 to 2.15, respectively). There was also some weak evidence suggesting that patients taking duloxetine experienced more adverse events than paroxetine (OR 1.24; 95% CI 0.99 to 1.55).
Authors’ conclusions
Duloxetine did not seem to provide a significant advantage in efficacy over other antidepressive agents for the acute-phase treatment of major depression. No differences in terms of efficacy were found, even though duloxetine was worse than some SSRIs (most of all, escitalopram) and newer antidepressants (like venlafaxine) in terms of acceptability and tolerability. Unfortunately, we only found evidence comparing duloxetine with a handful of other active antidepressive agents and only a few trials per comparison were found (in some cases we retrieved just one trial). This limited the power of the review to detect moderate, but clinically meaningful differences between the drugs. As many statistical tests have been used in the review, the findings from this review are better thought of as hypothesis forming rather than hypothesis testing and it would be very comforting to see the conclusions replicated in future trials. Most of included studies were sponsored by the drug industry manufacturing duloxetine. As for all other new investigational compounds, the potential for overestimation of treatment effect due to sponsorship bias should be borne in mind. In the present review no trials reported economic outcomes. Given that several SSRIs and the great majority of antidepressants are now available as generic formulation (only escitalopram, desvenlafaxine and duloxetine are still on patent), more comprehensive economic estimates of antidepressant treatment effect should be considered to better inform healthcare policy.
doi:10.1002/14651858.CD006533.pub2
PMCID: PMC4169791  PMID: 23076926
Antidepressive Agents [*therapeutic use]; Citalopram [therapeutic use]; Cyclohexanols [therapeutic use]; Depression [drug therapy]; Dibenzothiazepines [therapeutic use]; Fluoxetine [therapeutic use]; Paroxetine [therapeutic use]; Randomized Controlled Trials as Topic; Thiophenes [*therapeutic use]; Humans
22.  Work correlates of back problems and activity restriction due to musculoskeletal disorders in the Canadian national population health survey (NPHS) 1994-5 data 
OBJECTIVES—To describe the prevalence of musculoskeletal problems in the Canadian working population and to determine cross sectional associations between such problems and work factors, particularly job strain and physical demand variables.
METHODS—The Canadian 1994 national population health survey (NPHS) sampled 4230 working men and 4043 working women (ages 18-64) who answered an abbreviated version of the job content questionnaire. Workers were classified into four strain categories: high, passive, active, and low. Outcomes were restricted activity due to musculoskeletal disorders and the diagnosis of a back problem (both yes or no). Survey weights were incorporated to allow for different probabilities of selection. Logistic regression analyses were carried out separately for women and men, controlling for sociodemographic factors.
RESULTS—Prevalence of chronic back problems diagnosed by a health practitioner was 14.5% among men and 12.5% among women. Men had a 6.6% prevalence of restricted activity due to musculoskeletal disorders, whereas the corresponding figure for women was 5.3%. Women, but not men, in high strain jobs were more likely to report both back problems (odds ratio (OR) 1.60, 95% confidence interval (95% CI) 1.14 to 2.28) and restricted activity (OR 1.98, 95% CI 1.16 to 3.48) compared with those in low strain jobs. High physical exertion was an independent predictor of back problems in both sexes. For both men and women, low social support at work and high job insecurity were independent predictors of restricted activity due to musculoskeletal disorders. Conversely, chronic back problems contributed to explanation of high job strain among women (OR 1.76, 95% CI 1.30 to 2.39) and high physical exertion among men (OR 1.39, 95% CI 1.09 to 1.77), whereas restricted activity due to musculoskeletal disorders contributed to explanation of high job insecurity in both sexes.
CONCLUSIONS—Associations of interest between work stressors and musculoskeletal problems in this cross sectional study provide evidence for physical and psychosocial factors both affecting disability and being affected by disability in a working population.


Keywords: back pain; cross sectional survey; job strain; Canada
doi:10.1136/oem.58.11.728
PMCID: PMC1740062  PMID: 11600729
23.  Spinal Cord Stimulation for Neuropathic Pain 
Executive Summary
Objective
The objective of this health technology policy assessment was to determine the effectiveness of spinal cord stimulation (SCS) to manage chronic intractable neuropathic pain and to evaluate the adverse events and Ontario-specific economic profile of this technology.
Clinical Need
SCS is a reversible pain therapy that uses low-voltage electrical pulses to manage chronic, intractable neuropathic pain of the trunk or limbs. Neuropathic pain begins or is caused by damage or dysfunction to the nervous system and can be difficult to manage.
The prevalence of neuropathic pain has been estimated at about 1.5% of the population in the United States and 1% of the population in the United Kingdom. These prevalence rates are generalizable to Canada.
Neuropathic pain is extremely difficult to manage. People with symptoms that persist for at least 6 months or who have symptoms that last longer than expected for tissue healing or resolution of an underlying disease are considered to have chronic pain. Chronic pain is an emotional, social, and economic burden for those living with it. Depression, reduced quality of life (QOL), absenteeism from work, and a lower household income are positively correlated with chronic pain.
Although the actual number is unknown, a proportion of people with chronic neuropathic pain fail to obtain pain relief from pharmacological therapies despite adequate and reasonable efforts to use them. These people are said to have intractable neuropathic pain, and they are the target population for SCS.
The most common indication for SCS in North America is chronic intractable neuropathic pain due to failed back surgery syndrome (FBSS), a term that describes persistent leg or back and leg pain in patients who have had back or spine surgery. Neuropathic pain due to complex regional pain syndrome (CRPS), which can develop in the distal aspect of a limb a minor injury, is another common indication. To a lesser extent, chronic intractable pain of postherpetic neuralgia, which is a persistent burning pain and hyperesthesia along the distribution of a cutaneous nerve after an attack of herpes zoster, is also managed with SCS.
For each condition, SCS is considered as a pain management therapy only after conventional pain therapies, including pharmacological, nonpharmacological, and surgical treatments, if applicable, have been attempted and have failed.
The Technology
The SCS technology consists of 3 implantable components: a pulse generator, an extension cable, and a lead (a small wire). The pulse generator is the power source for the spinal cord stimulator. It generates low-voltage electrical pulses. The extension cable connects the pulse generator to the lead. The lead is a small, insulated wire that has a set of electrodes at one end. The lead is placed into the epidural space on the posterior aspect of the spinal cord, and the electrodes are positioned at the level of the nerve roots innervating the painful area. An electrical current from the electrodes induces a paresthesia, or a tingling sensation that masks the pain.
Before SCS is initiated, candidates must have psychological testing to rule out major psychological illness, drug habituation, and issues of secondary gain that can negatively influence the success of the therapy. Successful candidates will have a SCS test stimulation period (trial period) to assess their responsiveness to SCS. The test stimulation takes about 1 week to complete, and candidates who obtain at least 50% pain relief during this period are deemed suitable to receive a permanent implantation of a spinal cord stimulator
Review Strategy
The Medical Advisory Secretariat (MAS) reviewed all published health technology assessments of spinal cord stimulation. Following this, a literature search was conducted from 2000 to January, 2005 and a systematic review of the literature was completed. The primary outcome for the systematic review was pain relief. Secondary outcomes included functional status and quality of life. After applying the predetermined inclusion and exclusion criteria, 2 randomized controlled trials (MAS level 2 evidence), and 2 prospective non-randomized controlled trials with a before-and-after-treatment study design (MAS level 3a evidence) were retrieved and reviewed.
Summary of Findings
The authors of 6 health technology assessments concluded that evidence exists to support the effectiveness of SCS to decrease pain in various neuropathic pain syndromes. However, the quality of this evidence varied among reports from weak to moderate.
The systematic review completed by MAS found high quality level 2 evidence that SCS decreases pain and level 3a evidence that it improves functional status and quality of life in some people with neuropathic pain conditions. The rate of technical failures was approximately 11%, which included electrode lead migration and/or malposition. Procedural complications included infection and dural puncture; each occurred at a rate of 1.2%.
Conclusions
SCS may be considered for patients with chronic, neuropathic pain for whom standard pain treatments have failed and when there is no indication for surgical intervention to treat the underlying condition.
PMCID: PMC3382299  PMID: 23074473
24.  Subgroups of musculoskeletal pain patients and their psychobiological patterns – The LOGIN study protocol 
Background
Pain conditions of the musculoskeletal system are very common and have tremendous socioeconomic impact. Despite its high prevalence, musculoskeletal pain remains poorly understood and predominantly non-specifically and insufficiently treated.
The group of chronic musculoskeletal pain patients is supposed to be heterogeneous, due to a multitude of mechanisms involved in chronic pain. Psychological variables, psychophysiological processes, and neuroendocrine alterations are expected to be involved. Thus far, studies on musculoskeletal pain have predominantly focused on the general aspects of pain processing, thus neglecting the heterogeneity of patients with musculoskeletal pain. Consequently, there is a need for studies that comprise a multitude of mechanisms that are potentially involved in the chronicity and spread of pain. This need might foster research and facilitate a better pathophysiological understanding of the condition, thereby promoting the development of specific mechanism-based treatments for chronic pain. Therefore, the objectives of this study are as follows: 1) identify and describe subgroups of patients with musculoskeletal pain with regard to clinical manifestations (including mental co-morbidity) and 2) investigate whether distinct sensory profiles or 3) distinct plasma levels of pain-related parameters due to different underlying mechanisms can be distinguished in various subgroups of pain patients.
Methods/Design
We will examine a population-based chronic pain sample (n = 100), a clinical tertiary care sample (n = 100) and pain-free patients with depression or post-traumatic stress disorder and pain-free healthy controls (each n = 30, respectively). The samples will be pain localisation matched by sex and age to the population-based sample. Patients will undergo physical examination and thorough assessments of mental co-morbidity (including psychological trauma), perceptual and central sensitisation (quantitative sensory testing), descending inhibition (conditioned pain modulation, the diffuse noxious inhibitory control-like effect), as well as measurement of the plasma levels of nerve growth factor and endocannabinoids.
Discussion
The identification of the underlying pathophysiologic mechanisms in different subgroups of chronic musculoskeletal pain patients will contribute to a mechanism-based subgroup classification. This will foster the development of mechanism-based treatments and holds promise to treat patients more sufficient.
doi:10.1186/1471-2474-13-136
PMCID: PMC3476389  PMID: 22862787
Chronic non-specific musculoskeletal pain; Endocannabinoids; Mental comorbidity; Pain drawing; Pain extent; Quantitative sensory testing; Mechanism-based; Subgroup classification; Nerve growth factor; Trauma
25.  Shoulder pain 
Clinical Evidence  2010;2010:1107.
Introduction
Shoulder pain is a common problem with an estimated prevalence of 4% to 26%. About 1% of adults aged over 45 years consult their GP with a new presentation of shoulder pain every year in the UK. The aetiology of shoulder pain is diverse and includes pathology originating from the neck, glenohumeral joint, acromioclavicular joint, rotator cuff, and other soft tissues around the shoulder girdle. The most common source of shoulder pain is the rotator cuff, accounting for over two-thirds of cases.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of oral drug treatment, topical drug treatment, local injections, non-drug treatment, and surgical treatment? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 71 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, arthroscopic subacromial decompression, autologous whole blood injection, corticosteroids (oral, subacromial injection, or intra-articular injection), electrical stimulation, excision of distal clavicle, extracorporeal shock wave therapy, ice, laser treatment, manipulation under anaesthesia, suprascapular nerve block, non-steroidal anti-inflammatory drugs (oral, topical or intra-articular injection), opioid analgesics, paracetamol, physiotherapy (manual treatment, exercises), platelet-rich plasma injection, rotator cuff repair, shoulder arthroplasty, and ultrasound.
Key Points
Shoulder pain encompasses a diverse array of pathologies and can affect as many as one quarter of the population depending on age and risk factors. Shoulder pain may be due to problems with the neck, glenohumeral joint, acromioclavicular joint, rotator cuff, or other soft tissues around the shoulder.
Rotator cuff problems are the most common source of shoulder pain, accounting for more than two-thirds of cases. Rotator cuff disorders are associated with musculoskeletal problems that affect the joints and muscles of the shoulder, cuff degeneration due to ageing and ischaemia, and overloading of the shoulder.
Frozen shoulder (adhesive capsulitis) accounts for 2% of cases of shoulder pain. Risk factors for frozen shoulder include female sex, older age, shoulder trauma and surgery, diabetes, and cardiovascular, cerebrovascular, and thyroid disease.
In many people, the cornerstone of treatment is achieving pain control to permit a return to normal functional use of the shoulder and encourage this with manual exercises. In people with acute post-traumatic tear, an early surgical option is warranted.
We don't know whether topical NSAIDs, oral corticosteroids, oral paracetamol, or opioid analgesics improve shoulder pain, although oral NSAIDs may be effective in the short term in people with acute tendonitis/subacromial bursitis. If pain control fails, the diagnosis should be reviewed and other interventions considered.
Physiotherapy may improve pain and function in people with mixed shoulder disorders compared with placebo.
Intra-articular corticosteroid injections may reduce pain in the short term compared with physiotherapy and placebo for people with frozen shoulder, but their benefit in the long term and when compared with local anaesthetic is unclear.
Platelet-rich plasma injections may improve the speed of recovery in terms of pain and function in people having open subacromial decompression for rotator cuff impingement, but further evidence is needed.
Acupuncture may not improve pain or function in people with rotator cuff impingement compared with placebo or ultrasound.
Extracorporeal shock wave therapy may improve pain in calcific tendonitis.
We found some evidence that suprascapular nerve block, laser treatment, and arthroscopic subacromial decompression may be effective in some people with shoulder pain.
We don't know whether autologous blood injections, intra-articular NSAID injections, subacromial corticosteroid injections, electrical stimulation, ice, ultrasound, rotator cuff repair, manipulation under anaesthesia, or shoulder arthroplasty are effective as we found insufficient evidence on their effects.
PMCID: PMC3217726  PMID: 21418673

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