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1.  Patients' views on responsibility for the management of musculoskeletal disorders – A qualitative study 
Background
Musculoskeletal disorders are very common and almost inevitable in an individual's lifetime. Enabling self-management and allowing the individual to take responsibility for care is stated as desired in the management of these disorders, but this may be asking more than people can generally manage. A willingness among people to take responsibility for musculoskeletal disorders and not place responsibility out of their hands or on employers but to be shared with medical professionals has been shown. The aim of the present study was to describe how people with musculoskeletal disorders think and reason regarding responsibility for prevention, treatment and management of the disorder.
Methods
Individual interviews with a strategic sample of 20 individuals with musculoskeletal disorders were performed. The interviews were tape-recorded, transcribed verbatim and analysed according to qualitative content analysis.
Results
From the interviews an overarching theme was identified: own responsibility needs to be met. The analysis revealed six interrelated categories: Taking on responsibility, Ambiguity about responsibility, Collaborating responsibility, Complying with recommendations, Disclaiming responsibility, and Responsibility irrelevant. These categories described different thoughts and reasoning regarding the responsibility for managing musculoskeletal disorders. Generally the responsibility for prevention of musculoskeletal disorders was described to lie primarily on society/authorities as they have knowledge of what to prevent and how to prevent it. When musculoskeletal disorders have occurred, health care should provide fast accessibility, diagnosis, prognosis and support for recovery. For long-term management, the individuals themselves are responsible for making the most out of life despite disorders.
Conclusion
No matter what the expressions of responsibility for musculoskeletal disorders are, own responsibility needs to be met by society, health care, employers and family in an appropriate way, with as much or as little of the "right type" of support needed, based on the individual's expectations.
doi:10.1186/1471-2474-10-103
PMCID: PMC2753559  PMID: 19686602
2.  Studying the association between musculoskeletal disorders, quality of life and mental health. A primary care pilot study in rural Crete, Greece 
Background
The burden of musculoskeletal disorders (MSD) on the general health and well-being of the population has been documented in various studies. The objective of this study was to explore the association between MSD and the quality of life and mental health of patients and to discuss issues concerning care seeking patterns in rural Greece.
Methods
Patients registered at one rural Primary Care Centre (PCC) in Crete were invited to complete the Nordic Musculoskeletal Questionnaire (NMQ) for the analysis of musculoskeletal symptoms, together with validated instruments for measuring health related quality of life (SF-36) and mental distress (GHQ-28).
Results
The prevalence rate of MSD was found to be 71.2%, with low back and knee pain being the most common symptoms. Most conditions significantly impaired the quality of life, especially the physical dimensions of SF-36. Depression was strongly correlated to most MSD (p < 0.001). Multiple logistic analyses revealed that patients who consulted the PCC due to MSD were likely to have more mental distress or impaired physical functioning compared to those who did not.
Conclusion
Musculoskeletal disorders were common in patients attending the rural PCC of this study and were associated with a poor quality of life and mental distress that affected their consultation behaviour.
doi:10.1186/1471-2474-10-143
PMCID: PMC2785760  PMID: 19930570
3.  Musculoskeletal disorders in physically active conscripts: a one-year follow-up study in the Finnish Defence Forces 
Background
Musculoskeletal disorders (MSDs) are an important cause for morbidity in military service. They result in disabilities needing long-term rehabilitation and functional impairment leading to premature discharge from military service. The purpose of the study was to investigate the incidence and nature of MSDs in Finnish conscripts.
Methods
Two successive arrivals of 18–28-yr-old male conscripts (N = 955, median age 19) were followed for six months. MSDs, including overuse and acute injuries, treated at the garrison clinic were identified and analysed.
Results
During the 12-month study period there were 437 outpatient clinic visits in 955 persons. The occurrence rate was 33% during 6-month service while the event-based incidence was 3.3 per 1000 person-days. Occurrence peaked in summer months. The most common types of MSDs were low back pain (LBP, 20%), lower limb overuse injuries (16%) and sprains or strains (13%). Disorders mostly occurred in combat training in combat gear (40%) and during marching on foot or bicycle (28%). Overuse-related MSDs were more prevalent (66%) than traumatic ones (34%). One-third (34%) of the MSDs were recurrent and 66% were new ones. Disorders of the back and the knee were most frequently recurrent conditions (44% for both). Fractures, knee ligament ruptures, dislocations and muscle strains accounted for the highest number of service days lost. Twenty-four (2.5%) out of 955 conscripts were prematurely discharged due to MSDs.
Conclusion
Preventive measures during military service should be targeted at decreasing low back pain and lower limb overuse injuries, because these inflict the largest burden of MSDs and tend to have a chronic nature.
doi:10.1186/1471-2474-10-89
PMCID: PMC2724399  PMID: 19624829
4.  Analyzing musculoskeletal neck pain, measured as present pain and periods of pain, with three different regression models: a cohort study 
Background
In the literature there are discussions on the choice of outcome and the need for more longitudinal studies of musculoskeletal disorders. The general aim of this longitudinal study was to analyze musculoskeletal neck pain, in a group of young adults. Specific aims were to determine whether psychosocial factors, computer use, high work/study demands, and lifestyle are long-term or short-term factors for musculoskeletal neck pain, and whether these factors are important for developing or ongoing musculoskeletal neck pain.
Methods
Three regression models were used to analyze the different outcomes. Pain at present was analyzed with a marginal logistic model, for number of years with pain a Poisson regression model was used and for developing and ongoing pain a logistic model was used. Presented results are odds ratios and proportion ratios (logistic models) and rate ratios (Poisson model). The material consisted of web-based questionnaires answered by 1204 Swedish university students from a prospective cohort recruited in 2002.
Results
Perceived stress was a risk factor for pain at present (PR = 1.6), for developing pain (PR = 1.7) and for number of years with pain (RR = 1.3). High work/study demands was associated with pain at present (PR = 1.6); and with number of years with pain when the demands negatively affect home life (RR = 1.3). Computer use pattern (number of times/week with a computer session ≥ 4 h, without break) was a risk factor for developing pain (PR = 1.7), but also associated with pain at present (PR = 1.4) and number of years with pain (RR = 1.2). Among life style factors smoking (PR = 1.8) was found to be associated to pain at present. The difference between men and women in prevalence of musculoskeletal pain was confirmed in this study. It was smallest for the outcome ongoing pain (PR = 1.4) compared to pain at present (PR = 2.4) and developing pain (PR = 2.5).
Conclusion
By using different regression models different aspects of neck pain pattern could be addressed and the risk factors impact on pain pattern was identified. Short-term risk factors were perceived stress, high work/study demands and computer use pattern (break pattern). Those were also long-term risk factors. For developing pain perceived stress and computer use pattern were risk factors.
doi:10.1186/1471-2474-10-73
PMCID: PMC2714495  PMID: 19545386
5.  The panorama of future sick-leave diagnoses among young adults initially long-term sickness absent due to neck, shoulder, or back diagnoses. An 11-year prospective cohort study 
Background
Little is known about future sick-leave diagnoses among individuals on long-term sickness absence. The aim of this study was to describe the panorama of sick-leave diagnoses over time among young adults initially sick-listed for ≥ 28 days due to back, neck, or shoulder diagnoses
Methods
An 11-year prospective population-based cohort study including all 213 individuals in a Swedish municipality who, in 1985, were aged 25–34 years and had a new sick-leave spell ≥ 28 days due to neck, shoulder, or back diagnoses.
Results
Over the 11-year period, the young adults in this cohort had 176,825 sick-leave days in 7,878 sick-leave periods (in 4,610 sick-leave spells) due to disorders in 17 of the 18 ICD-8 diagnostic categories (International Classification of Diseases, Revision 8). Musculoskeletal or mental diagnoses accounted for most of the sick-leave days, whereas most of the sick-leave periods were due to musculoskeletal, respiratory, or infectious disorders, or to unclassified symptoms. Most cohort members had had four to eight different sick-leave diagnoses over the 11 years, although some had had up to 11 diagnoses. Only two individuals (1%) had been sickness absent solely due to musculoskeletal diagnoses.
Conclusion
Although the young adults initially were sick listed with back, neck, or shoulder diagnoses, their sickness absence during the follow up were due to a wide variety of other medical diagnoses. It might be that the ill-health content of sickness absence due to back pain is greater than usually assumed. More research on prognoses of sick-leave diagnoses among long-term sick listed is warranted.
doi:10.1186/1471-2474-10-84
PMCID: PMC2719585
6.  How well do questionnaires on symptoms in neck-shoulder disorders capture the experiences of those who suffer from neck-shoulder disorders? A content analysis of questionnaires and interviews 
Background
Previous research has indicated neck-shoulder disorders to have a fluctuating course incorporating a variety of symptoms. These findings awoke our interest to make a comparison between symptoms experienced by people affected with the disorder and the content of questionnaires that assess pain and other symptoms in neck-shoulder disorders. Thus the aims of this study were: -to explore the symptoms experienced by people with non-specific neck-shoulder problems, as well as experiences of nuances and temporal variations (fluctuations) of symptoms; -to investigate which sources were used in the development of ten questionnaires for assessing pain and other symptoms in the neck-shoulder; -to analyse the item content of the questionnaires; -to analyse the correspondence between the item content of the questionnaires and the symptoms described by the informants.
Methods
Content analysis of interviews with 40 people with non-specific neck-shoulder pain, and 10 questionnaires used to assess pain and other symptoms in neck-shoulder disorders.
Results
The interviews revealed a variety of symptoms indicating a bodily, mental/cognitive, and emotional engagement, and more general and severe symptoms than are usually considered in neck-shoulder questionnaires. Taking all questionnaires together many of the symptoms were considered, but most questionnaires only included a few of them. The informants were able to distinguish fluctuation of symptoms, and a variety of different qualities which were not usually considered in the questionnaires. Only two questionnaires had made use of the opinions of affected people in the development.
Conclusion
Few of the questionnaires had made use of the experiences of affected people in the development. The correspondence between the symptoms expressed by those affected and the content of the questionnaires was low. A variety of symptoms were expressed by the interviewees, and the participants were also able to distinguish nuances and fluctuations of symptoms. The present study points to the importance of other aspects than just pain and physical functioning as clinical trial outcome measures related to neck-shoulder disorders. To develop a condition-specific questionnaire, it is important to decide on the specific symptoms for the condition. Using the experiences of those affected, in combination with relevant research and professional knowledge, can enhance the validity of the questionnaires.
doi:10.1186/1471-2474-10-30
PMCID: PMC2670265  PMID: 19272142
7.  Does a dose-response relation exist between spinal pain and temporomandibular disorders? 
Background
The aim of this study was to test whether a reciprocal dose-response relation exists between frequency/severity of spinal pain and temporomandibular disorders (TMD).
Methods
A total of 616 subjects with varying severity of spinal pain or no spinal pain completed a questionnaire focusing on symptoms in the jaw, head and spinal region. A subset of the population (n = 266) were sampled regardless of presence or absence of spinal pain. We used two different designs, one with frequency/severity of spinal pain, and the other, with frequency/severity of TMD symptoms as independent variable. All 616 participants were allocated to four groups, one control group without spinal pain and three spinal pain groups. The subjects in the subset were allocated to one control group without TMD symptoms and three TMD groups. Odds ratios (ORs) were calculated for presence of frequent TMD symptoms in the separate spinal pain groups as well as for frequent spinal pain in the separate TMD groups.
Results
The analysis showed increasing ORs for TMD with increasing frequency/severity of spinal pain. We also found increasing ORs for spinal pain with increasing frequency/severity of TMD symptoms.
Conclusion
This study shows a reciprocal dose-response-like relationship between spinal pain and TMD. The results indicate that these two conditions may share common risk factors or that they may influence each other. Studies on the temporal sequence between spinal pain and TMD are warranted.
doi:10.1186/1471-2474-10-28
PMCID: PMC2653030  PMID: 19254384
8.  Short-term effects of implemented high intensity shoulder elevation during computer work 
Background
Work-site strength training sessions are shown effective to prevent and reduce neck-shoulder pain in computer workers, but difficult to integrate in normal working routines. A solution for avoiding neck-shoulder pain during computer work may be to implement high intensity voluntary contractions during the computer work. However, it is unknown how this may influence productivity, rate of perceived exertion (RPE) as well as activity and rest of neck-shoulder muscles during computer work. The aim of this study was to investigate short-term effects of a high intensity contraction on productivity, RPE and upper trapezius activity and rest during computer work and a subsequent pause from computer work.
Methods
18 female computer workers performed 2 sessions of 15 min standardized computer mouse work preceded by 1 min pause with and without prior high intensity contraction of shoulder elevation. RPE was reported, productivity (drawings per min) measured, and bipolar surface electromyography (EMG) recorded from the dominant upper trapezius during pauses and sessions of computer work. Repeated measure ANOVA with Bonferroni corrected post-hoc tests was applied for the statistical analyses.
Results
The main findings were that a high intensity shoulder elevation did not modify RPE, productivity or EMG activity of the upper trapezius during the subsequent pause and computer work. However, the high intensity contraction reduced the relative rest time of the uppermost (clavicular) trapezius part during the subsequent pause from computer work (p < 0.04).
Conclusion
Since a preceding high intensity shoulder elevation did not impose a negative impact on perceived effort, productivity or upper trapezius activity during computer work, implementation of high intensity contraction during computer work to prevent neck-shoulder pain may be possible without affecting the working routines. However, the unexpected reduction in clavicular trapezius rest during a pause with preceding high intensity contraction requires further investigation before high intensity shoulder elevations can be recommended as an integrated part of computer work.
doi:10.1186/1471-2474-10-101
PMCID: PMC2731070  PMID: 19664264
9.  The prevalence of neovascularity in patients clinically diagnosed with rotator cuff tendinopathy 
Background
Shoulder dysfunction is common and pathology of the rotator cuff tendons and subacromial bursa are considered to be a major cause of pain and morbidity. Although many hypotheses exist there is no definitive understanding as to the origin of the pain arising from these structures. Research investigations from other tendons have placed intra-tendinous neovascularity as a potential mechanism of pain production. The prevalence of neovascularity in patients with a clinical diagnosis of rotator cuff tendinopathy is unknown. As such the primary aim of this pilot study was to investigate if neovascularity could be identified and to determine the prevalence of neovascularity in the rotator cuff tendons and subacromial bursa in subjects with unilateral shoulder pain clinically assessed to be rotator cuff tendinopathy. The secondary aims were to investigate the association between the presence of neovascularity and pain, duration of symptoms, and, neovascularity and shoulder function.
Methods
Patients with a clinical diagnosis of unilateral rotator cuff tendinopathy referred for a routine diagnostic ultrasound (US) scan in a major London teaching hospital formed the study population. At referral patients were provided with an information document. On the day of the scan (on average, at least one week later) the patients agreeing to participate were taken through the consent process and underwent an additional clinical examination prior to undergoing a bilateral grey scale and colour Doppler US examination (symptomatic and asymptomatic shoulder) using a Philips HDI 5000 Sono CT US machine. The ultrasound scans were performed by one of two radiologists who recorded their findings and the final assessment was made by a third radiologist blinded both to the clinical examination and the ultrasound examination. The findings of the radiologists who performed the scans and the blinded radiologist were compared and any disagreements were resolved by consensus.
Results
Twenty-six patients agreed to participate and formed the study population. Of these, 6 subjects were not included in the final assessment following the pre-scan clinical investigation. This is because one subject had complete cessation of symptoms between the time of the referral and entry into the trial. Another five had developed bilateral shoulder pain during the same period. The mean age of the 20 subjects forming the study population was 50.2 (range 32-69) years (SD = 10.9) and the mean duration of symptoms was 22.6 (range .75 to 132) months (SD = 40.1). Of the 20 subjects included in the formal analysis, 13 subjects (65%) demonstrated neovascularity in the symptomatic shoulder and 5 subjects (25%) demonstrated neovascularity in the asymptomatic shoulder. The subject withdrawn due to complete cessation of symptoms was not found to have neovascularity in either shoulder and of the 5 withdrawn due to bilateral symptoms; two subjects were found to have signs of bilateral neovascularity, one subject demonstrated neovascularity in one shoulder and two subjects in neither shoulder.
Conclusions
This study demonstrated that neovascularity does occur in subjects with a clinical diagnosis of rotator cuff tendinopathy and to a lesser extent in asymptomatic shoulders. In addition, the findings of this investigation did not identify an association between the presence of neovascularity; and pain, duration of symptoms or shoulder function. Future research is required to determine the relevance of these findings.
doi:10.1186/1471-2474-10-163
PMCID: PMC2813234  PMID: 20025761
10.  Cognitive impairment in patients with Fibromyalgia syndrome as assessed by the Mini-Mental State Examination 
Background
This study evaluated the frequency of cognitive impairment in patients with Fibromyalgia syndrome (FMS) using the Mini Mental State Examination (MMSE).
Methods
We analyzed baseline data from all 46 patients with FMS and 92 age- and sex-matched controls per diagnosis of neuropathic (NeP) or mixed pain (MP) selected from a larger prospective study.
Results
FMS had a slight but statistically significant lower score in the adjusted MMSE score (26.9; 95% CI 26.7-27.1) than either NeP (27.3; 95% CI 27.2-27.4) or MP (27.3; 27.2-27.5). The percentage of patients with congnitive impairment (adjusted MMSE ≤ 26) was numerically higher in FMS (15%; 95% CI 6.3-29) compared with NeP (5%; 95% CI 1.8-12.2) or MP (5%; 95% CI 1.8-12.2) and higher than in the same age stratum of the general population (0.05%).
Conclusions
Compared with the population reference value, patients with FMS showed high frequency of cognitive impairment.
doi:10.1186/1471-2474-10-162
PMCID: PMC2811106  PMID: 20025750
11.  Association between knee alignment and knee pain in patients surgically treated for medial knee osteoarthritis by high tibial osteotomy. A one year follow-up study 
Background
The association between knee alignment and knee pain in knee osteoarthritis (OA) is unclear. High tibial osteotomy, a treatment option in knee OA, alters load from the affected to the unaffected compartment of the knee by correcting malalignment. This surgical procedure thus offers the possibility to study the cross-sectional and longitudinal association of alignment to pain. The aims were to study 1) the preoperative association of knee alignment to preoperative knee pain and 2) the association of change in knee alignment with surgery to change in knee pain over time in patients operated on for knee OA by high tibial osteotomy.
Methods
182 patients (68% men) mean age 53 years (34 - 69) with varus alignment having tibial osteotomy by the hemicallotasis technique for medial knee OA were consecutively included. Knee alignment was assessed by the Hip-Knee-Ankle (HKA) angle from radiographs including the hip and ankle joints. Knee pain was measured by the subscale pain (0 - 100, worst to best scale) of the Knee injury and Osteoarthritis Outcome Score (KOOS) preoperatively and at one year follow-up. To estimate the association between knee alignment and knee pain multivariate regression analyses were used.
Results
Mean preoperative varus alignment was 170 degrees (153 - 178) and mean preoperative KOOS pain was 42 points (3 - 86). There was no association between preoperative varus alignment and preoperative KOOS pain, crude analysis 0.02 points (95% CI -0.6 - 0.7) change in pain with every degree of HKA angle, adjusted analysis 0.3 points (95% CI -1.3 - 0.6).
The mean postoperative knee alignment was 184 degrees (171 - 185). The mean change in knee alignment was 13 degrees (0 - 30). The mean change in KOOS pain was 32 (-16 - 83). There was neither any association between change in knee alignment and change in KOOS pain over time, crude analysis 0.3 point (95% CI -0.6 - 1.2), adjusted analysis 0.4 points (95% CI 0.6 - 1.4).
Conclusion
We found no association between knee alignment and knee pain in patients with knee OA indicating that alignment and pain are separate entities, and that the degree of preoperative malalignment is not a predictor of knee pain after high tibial osteotomy.
doi:10.1186/1471-2474-10-154
PMCID: PMC2796991  PMID: 19995425
12.  The predictive effect of fear-avoidance beliefs on low back pain among newly qualified health care workers with and without previous low back pain: a prospective cohort study 
Background
Health care workers have a high prevalence of low back pain (LBP). Although physical exposures in the working environment are linked to an increased risk of LBP, it has been suggested that individual coping strategies, for example fear-avoidance beliefs, could also be important in the development and maintenance of LBP. Accordingly, the main objective of this study was to examine (1) the association between physical work load and LBP, (2) the predictive effect of fear-avoidance beliefs on the development of LBP, and (3) the moderating effect of fear-avoidance beliefs on the association between physical work load and LBP among cases with and without previous LBP.
Methods
A questionnaire survey among 5696 newly qualified health care workers who completed a baseline questionnaire shortly before completing their education and a follow-up questionnaire 12 months later. Participants were selected on the following criteria: (a) being female, (b) working in the health care sector (n = 2677). Multinomial logistic regression analysis was used to evaluate the effect of physical work load and fear-avoidance beliefs on the severity of LBP.
Results
For those with previous LBP, physical work load has an importance, but not among those without previous LBP. In relation to fear-avoidance beliefs, there is a positive relation between it and LBP of than 30 days in both groups, i.e. those without and with previous LBP. No moderating effect of fear-avoidance beliefs on the association between physical work load and LBP was found among cases with and without LBP.
Conclusion
Both physical work load and fear-avoidance beliefs matters in those with previous LBP. Only fear-avoidance beliefs matters in those without previous LBP. The study did not find a moderating effect of fear-avoidance beliefs on the association between physical work load and LBP.
doi:10.1186/1471-2474-10-117
PMCID: PMC2759905  PMID: 19778413
13.  Thoracic spine pain in the general population: Prevalence, incidence and associated factors in children, adolescents and adults. A systematic review 
Background
Thoracic spine pain (TSP) is experienced across the lifespan by healthy individuals and is a common presentation in primary healthcare clinical practice. However, the epidemiological characteristics of TSP are not well documented compared to neck and low back pain. A rigorous evaluation of the prevalence, incidence, correlates and risk factors needs to be undertaken in order for epidemiologic data to be meaningfully used to develop evidence-based prevention and treatment recommendations for TSP.
Methods
A systematic review method was followed to report the evidence describing prevalence, incidence, associated factors and risk factors for TSP among the general population. Nine electronic databases were systematically searched to identify studies that reported either prevalence, incidence, associated factors (cross-sectional study) or risk factors (prospective study) for TSP in healthy children, adolescents or adults. Studies were evaluated for level of evidence and method quality.
Results
Of the 1389 studies identified in the literature, 33 met the inclusion criteria for this systematic review. The mean (SD) quality score (out of 15) for the included studies was 10.5 (2.0). TSP prevalence data ranged from 4.0–72.0% (point), 0.5–51.4% (7-day), 1.4–34.8% (1-month), 4.8–7.0% (3-month), 3.5–34.8% (1-year) and 15.6–19.5% (lifetime). TSP prevalence varied according to the operational definition of TSP. Prevalence for any TSP ranged from 0.5–23.0%, 15.8–34.8%, 15.0–27.5% and 12.0–31.2% for 7-day, 1-month, 1-year and lifetime periods, respectively. TSP associated with backpack use varied from 6.0–72.0% and 22.9–51.4% for point and 7-day periods, respectively. TSP interfering with school or leisure ranged from 3.5–9.7% for 1-year prevalence. Generally, studies reported a higher prevalence for TSP in child and adolescent populations, and particularly for females. The 1 month, 6 month, 1 year and 25 year incidences were 0–0.9%, 10.3%, 3.8–35.3% and 9.8% respectively. TSP was significantly associated with: concurrent musculoskeletal pain; growth and physical; lifestyle and social; backpack; postural; psychological; and environmental factors. Risk factors identified for TSP in adolescents included age (being older) and poorer mental health.
Conclusion
TSP is a common condition in the general population. While there is some evidence for biopsychosocial associations it is limited and further prospectively designed research is required to inform prevention and management strategies.
doi:10.1186/1471-2474-10-77
PMCID: PMC2720379  PMID: 19563667
14.  Optimising corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A protocol for a randomised control trial with placebo comparison 
Background
Corticosteroid injection and physiotherapy are two commonly prescribed interventions for management of lateral epicondylalgia. Corticosteroid injections are the most clinically efficacious in the short term but are associated with high recurrence rates and delayed recovery, while physiotherapy is similar to injections at 6 weeks but with significantly lower recurrence rates. Whilst practitioners frequently recommend combining physiotherapy and injection to overcome harmful effects and improve outcomes, study of the benefits of this combination of treatments is lacking. Clinicians are also faced with the paradox that the powerful anti-inflammatory corticosteroid injections work well, albeit in the short term, for a non-inflammatory condition like lateral epicondylalgia. Surprisingly, these injections have not been rigorously tested against placebo injections. This study primarily addresses both of these issues.
Methods
A randomised placebo-controlled clinical trial with a 2 × 2 factorial design will evaluate the clinical efficacy, cost-effectiveness and recurrence rates of adding physiotherapy to an injection. In addition, the clinical efficacy and adverse effects of corticosteroid injection beyond that of a placebo saline injection will be studied. 132 participants with a diagnosis of lateral epicondylalgia will be randomly assigned by concealed allocation to one of four treatment groups – corticosteroid injection, saline injection, corticosteroid injection with physiotherapy or saline injection with physiotherapy. Physiotherapy will comprise 8 sessions of elbow manipulation and exercise over an 8 week period. Blinded follow-up assessments will be conducted at baseline, 4, 8, 12, 26 and 52 weeks after randomisation. The primary outcome will be a participant rating of global improvement, from which measures of success and recurrence will be derived. Analyses will be conducted on an intention-to-treat basis using linear mixed and logistic regression models. Healthcare costs will be collected from a societal perspective, and along with willingness-to-pay and quality of life data will facilitate cost-effectiveness and cost-benefit analyses.
Conclusion
This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. Findings from this study will assist in the development of evidence based practice recommendations and potentially the optimisation of resource allocation for rehabilitating lateral epicondylalgia.
Trial registration
Australian New Zealand Clinical Trials Register ACTRN12609000051246
doi:10.1186/1471-2474-10-76
PMCID: PMC2707364  PMID: 19552805
15.  Development and validation of an index of musculoskeletal functional limitations 
Background
While musculoskeletal problems are leading sources of disability, there has been little research on measuring the number of functionally limiting musculoskeletal problems for use as predictor of outcome in studies of chronic disease. This paper reports on the development and preliminary validation of a self administered musculoskeletal functional limitations index.
Methods
We developed a summary musculoskeletal functional limitations index based upon a six-item self administered questionnaire in which subjects indicate whether they are limited a lot, a little or not at all because of problems in six anatomic regions (knees, hips, ankles and feet, back, neck, upper extremities). Responses are summed into an index score. The index was completed by a sample of total knee replacement recipients from four US states. Our analyses examined convergent validity at the item and at the index level as well as discriminant validity and the independence of the index from other correlates of quality of life.
Results
782 subjects completed all items of the musculoskeletal functional limitations index and were included in the analyses. The mean age of the sample was 75 years and 64% were female. The index demonstrated anticipated associations with self-reported quality of life, activities of daily living, WOMAC functional status score, use of walking support, frequency of usual exercise, frequency of falls and dependence upon another person for assistance with chores. The index was strongly and independently associated with self-reported overall health.
Conclusion
The self-reported musculoskeletal functional limitations index appears to be a valid measure of musculoskeletal functional limitations, in the aspects of validity assessed in this study. It is useful for outcome studies following TKR and shows promise as a covariate in studies of chronic disease outcomes.
doi:10.1186/1471-2474-10-62
PMCID: PMC2700076  PMID: 19500390
16.  Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial 
Background
The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation.
Methods/design
The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18–70 years) visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs.
Discussion
Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as much efficacy as the standard surgical procedure, and is more cost-effective, will be determined by this trial.
Trial registration
Current Controlled Trials ISRCTN25884790.
doi:10.1186/1471-2474-10-49
PMCID: PMC2697136  PMID: 19439098
17.  Cross-sectional analysis of baseline differences of candidates for rotator cuff surgery: a sex and gender perspective 
Background
The word "sex" refers to biological differences between men and women. Gender refers to roles, behaviors, activities, and attributes that a given society considers appropriate for men and women. Traditionally, treatment decisions have been based on patient's sex without including the gender. Assessment of disability secondary to musculoskeletal problems would not be complete or accurate unless potentially relevant biological and non-biological aspects of being a man or woman are taken into consideration. The purposes of this study were to: 1) investigate the difference in pre-operative characteristics between men and women who were candidates for rotator cuff surgery; and, 2) assess the relationship between level of disability and factors that represent sex and factors that signify gender.
Method
This was a cross-sectional study. The primary outcome measure of disability was a disease-specific outcome measure, the Western Ontario Rotator Cuff (WORC) index, and independent variables were sex, age, hand dominance, shoulder side involvement, BMI, co-morbidity, medication use, work status, smoking habits, strength, range of motion, level of pathology, concurrent osteoarthritis, expectations for recovery, and participation restriction. Parametric, non-parametric, univariable, subgroup, and multivariable analyses were conducted.
Results
One hundred and seventy patients were included in the study. The mean age was 57 ± 11, 85 were females. Women reported higher levels of disability despite similar or lower levels of pathology. Scores of the WORC were strongly influenced by factors that represented "gender" such as participation restriction (F = 28.91, p < 0.0001) and expectations for improved activities of daily living (F = 5.80, p = 0.004). Painfree combined range of motion, which represented an interaction between "sex" and "gender" was also associated with disability after being adjusted for all other relevant baseline factors (F = 25.82, p < 0.0001).
Conclusion
Gender-related factors such as expectations and participation limitations have an independent impact on disability in men and women undergoing rotator cuff related surgery.
doi:10.1186/1471-2474-10-26
PMCID: PMC2656456  PMID: 19239706
18.  Dry needling and exercise for chronic whiplash - a randomised controlled trial 
Background
Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash.
Method/Design
A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1) dry-needling, advice and exercise or 2) sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI) and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted.
Discussion
This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash.
Trial registration
ACTRN12609000470291
doi:10.1186/1471-2474-10-160
PMCID: PMC2805606  PMID: 20021675
19.  Physiotherapy alone or in combination with corticosteroid injection for acute lateral epicondylitis in general practice: A protocol for a randomised, placebo-controlled study 
Background
Lateral epicondylitis is a painful condition responsible for loss of function and sick leave for long periods of time. In many countries, the treatment guidelines recommend a wait-and-see policy, reflecting that no conclusions on the best treatment can be drawn from the available research, published studies and meta-analyses.
Methods/Design
Randomized double blind controlled clinical trial in a primary care setting. While earlier trials have either compared corticosteroid injections to physical therapy or to naproxen orally, we will compare the clinical effect of physiotherapy alone or physiotherapy combined with corticosteroid injection in the initial treatment of acute tennis elbow. Patients seeing their general practitioner with lateral elbow pain of recent onset will be randomised to one of three interventions: 1: physiotherapy, corticosteroid injection and naproxen or 2: physiotherapy, placebo injection and naproxen or 3: wait and see treatment with naproxen alone. Treatment and assessments are done by two different doctors, and the contents of the injection is unknown to both the treating doctor and patient. The primary outcome measure is the patient's evaluation of improvement after 6, 12, 26 and 52 weeks. Secondary outcome measures are pain, function and severity of main complaint, pain-free grip strength, maximal grip strength, pressure-pain threshold, the patient's satisfaction with the treatment and duration of sick leave.
Conclusion
This article describes a randomized, double blind, controlled clinical trial with a one year follow up to investigate the effects of adding steroid injections to physiotherapy in acute lateral epicondylitis.
Trial Registration
ClinicalTrials.gov Identifier: NCT00826462
doi:10.1186/1471-2474-10-152
PMCID: PMC2791749  PMID: 19961603
20.  Does physical activity change predict functional recovery in low back pain? Protocol for a prospective cohort study 
Background
Activity advice and prescription are commonly used in the management of low back pain (LBP). Although there is evidence for advising patients with LBP to remain active, facilitating both recovery and return to work, to date no research has assessed whether objective measurements of free living physical activity (PA) can predict outcome, recovery and course of LBP.
Methods
An observational longitudinal study will investigate PA levels in a cohort of community-dwelling working age adults with acute and sub-acute LBP. Each participant's PA level, functional status, mood, fear avoidance behaviours, and levels of pain, psychological distress and occupational activity will be measured on three occasions during for 1 week periods at baseline, 3 months, and 1 year. Physical activity levels will be measured by self report, RT3 triaxial accelerometer, and activity recall questionnaires. The primary outcome measure of functional recovery will be the Roland Morris Disability Questionnaire (RMDQ). Free living PA levels and changes in functional status will be quantified in order to look at predictive relationships between levels and changes in free living PA and functional recovery in a LBP population.
Discussion
This research will investigate levels and changes in activity levels of an acute LBP cohort and the predictive relationship to LBP recovery. The results will assess whether occupational, psychological and behavioural factors affect the relationship between free living PA and LBP recovery. Results from this research will help to determine the strength of evidence supporting international guidelines that recommend restoration of normal activity in managing LBP.
Trial registration
[Clinical Trial Registration Number, ACTRN12609000282280]
doi:10.1186/1471-2474-10-136
PMCID: PMC2777147  PMID: 19895697
21.  Randomised controlled trial of local corticosteroid injections for de Quervain's tenosynovitis in general practice 
Background
De Quervain's tenosynovitis is a stenosing tenosynovitis of the first dorsal compartment of the wrist and leads to wrist pain and to impaired function of the wrist and hand. It can be treated by splinting, local corticosteroid injection and operation. In this study effectiveness of local corticosteroid injections for de Quervain's tenosynovitis provided by general practitioners was assessed.
Methods
Participants with de Quervain's tenosynovitis were recruited by general practitioners. Short-term outcomes (one week after injections) were assessed in a randomised, placebo-controlled trial. Long-term effectiveness was evaluated in an open prospective cohort-study of steroid responders during a follow-up period of 12 months. Participants were randomised to one or two local injections of 1 ml of triamcinolonacetonide (TCA) or 1 ml of NaCl 0.9% (placebo). Non-responders to NaCl were treated with additional TCA injections. Main outcomes were immediate treatment response, severity of pain, improvement as perceived by participant and functional disability using sub items hand and finger function of the Dutch Arthritis Impact Measurement Scale (Dutch AIMS-2-HFF).
Results
11 general practitioners included 21 wrists in 21 patients. The TCA-group had better results for short-term outcomes treatment response (78% vs. 25%; p = 0.015), perceived improvement (78% vs. 33%; p = 0.047) and severity of pain (4.27 vs. 1.33; p = 0.031) but not for the Dutch-AIMS-HFF (2.71 vs. 1.92; p = 0.112). Absolute risk reduction for the main outcome short-term treatment response was 0.55 (95% CI: 0.34, 0.76) with a number needed to treat of 2 (95% CI: 1, 3). In the cohort of steroid responders (n = 12) the beneficial effects of steroid injections were sustained during the follow-up of 12 months regarding severity of pain (p = 0.67) and scores of Dutch AIMS-2-HFF (p = 0.36), but not for patient perceived improvement (p = 0.02). No adverse events were observed during the 12 months of follow-up.
Conclusion
One or two local injections of 1 ml triamcinolonacetonide 10 mg/ml provided by general practitioners leads to improvement in the short term in participants with de Quervain's tenosynovitis when compared to placebo. The short-term beneficial effects of steroid injections for symptoms were maintained during the follow-up after 12 months.
Trial registration
Current Controlled Trials ISRCTN53171398
doi:10.1186/1471-2474-10-131
PMCID: PMC2774677  PMID: 19860883
22.  Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain 
Background
Headache is a highly prevalent disorder. Irrespective of the headache diagnosis it is often accompanied with neck pain and -stiffness. Due to this common combination of headache and neck pain, physical treatments of the cervical spine are often considered. The additional value of these treatments to standard medical care or usual care (UC) is insufficiently documented.
We therefore wanted to compare the treatment effects of UC alone and in combination with manual therapy (MT) in patients with a combination of headache and neck pain. UC consisted of a stepped treatment approach according to the Dutch General Practitioners Guideline for headache, the additional MT consisted of articular mobilisations and low load exercises.
Due to insufficient enrolment the study was terminated prematurely. We aim to report not only our preliminary clinical findings but also to discuss the encountered difficulties and to formulate recommendations for future research.
Methods
A randomised clinical trial was conducted. Thirty-seven patients were included and randomly allocated to one of both treatment groups. The treatment period was 6 weeks, with follow-up measurements at weeks 7, 12 and 26. Primary outcome measures were global perceived effect (GPE) and the impact of the headache using the Headache Impact Test (HIT-6). Reduction in headache frequency, pain intensity, medication intake, absenteeism and the use of additional professional help were secondary outcome measures
Results
Significant improvements on primary and secondary outcome measures were recorded in both treatment groups. No significant differences between both treatment groups were found. The number of recruited patients remained low despite various strategies.
Conclusion
It appears that both treatment strategies can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed.
Trial registration number
NCT00298142
doi:10.1186/1471-2474-10-115
PMCID: PMC2758835  PMID: 19775434
23.  Green tea polyphenols and Tai Chi for bone health: Designing a placebo-controlled randomized trial 
Background
Osteoporosis is a major health problem in postmenopausal women. Evidence suggests the importance of oxidative stress in bone metabolism and bone loss. Tea consumption may be beneficial to osteoporosis due to its antioxidant capability. However, lack of objective data characterizing tea consumption has hindered the precise evaluation of the association between tea ingestion and bone mineral density in previous questionnaire-based epidemiological studies. On the other hand, although published studies suggest that Tai Chi (TC) exercise can benefit bone health and may reduce oxidative stress, all studies were conducted using a relatively healthy older population, instead of a high-risk one such as osteopenic postmenopausal women. Therefore, this study was designed to test an intervention including green tea polyphenol (GTP) and TC exercise for feasibility, and to quantitatively assess their individual and interactive effects on postmenopausal women with osteopenia.
Methods/Design
One hundred and forty postmenopausal women with osteopenia (defined as bone mineral density T-score at the spine and/or hip between 1 to 2.5 SD below the reference database) were randomly assigned to 4 treatment arms: (1) placebo group receiving 500 mg medicinal starch daily, (2) GTP group receiving 500 mg of GTP per day, (3) placebo+TC group receiving both placebo treatment and TC training (60-minute group exercise, 3 times per week), and (4) GTP+TC group receiving both GTP and TC training for 24 weeks. The outcome measures were bone formation biomarker (serum bone alkaline phosphatase), bone resorption biomarker (serum tartrate resistant acid phosphatase), and oxidative DNA damage biomarker (urinary 8-hydroxy-2'-deoxyguanosine). All outcome measures were determined at baseline, 4, 12, and 24 weeks. Urinary and serum GTP concentrations were also determined at baseline, 4, 12, and 24 weeks for bioavailability. Liver function was monitored monthly for safety. A model of repeated measurements with random effect error terms was applied. Traditional procedures such as ANCOVA, chi-squared analysis, and regression were used for comparisons.
Discussion
We present the rationale, design, and methodology of a placebo-controlled randomized trial to investigate a new complementary and alternative medicine strategy featuring a dietary supplement and a mind-body exercise for alleviating bone loss in osteopenic postmenopausal women.
Trial registration
ClinicalTrials.gov identifier: NCT00625391
doi:10.1186/1471-2474-10-110
PMCID: PMC2744652  PMID: 19732445
24.  Impact of leg lengthening on viscoelastic properties of the deep fascia 
Background
Despite the morphological alterations of the deep fascia subjected to leg lengthening have been investigated in cellular and extracellular aspects, the impact of leg lengthening on viscoelastic properties of the deep fascia remains largely unknown. This study aimed to address the changes of viscoelastic properties of the deep fascia during leg lengthening using uniaxial tensile test.
Methods
Animal model of leg lengthening was established in New Zealand white rabbits. Distraction was initiated at a rate of 1 mm/day and 2 mm/day in two steps, and preceded until increases of 10% and 20% in the initial length of tibia had been achieved. The deep fascia specimens of 30 mm × 10 mm were clamped with the Instron 1122 tensile tester at room temperature with a constant tensile rate of 5 mm/min. After 5 load-download tensile tests had been performed, the specimens were elongated until rupture. The load-displacement curves were automatically generated.
Results
The normal deep fascia showed typical viscoelastic rule of collagenous tissues. Each experimental group of the deep fascia after leg lengthening kept the properties. The curves of the deep fascia at a rate of 1 mm/day with 20% increase in tibia length were the closest to those of normal deep fascia. The ultimate tension strength and the strain at rupture on average of normal deep fascia were 2.69 N (8.97 mN/mm2) and 14.11%, respectively. The increases in ultimate tension strength and strain at rupture of the deep fascia after leg lengthening were statistically significant.
Conclusion
The deep fascia subjected to leg lengthening exhibits viscoelastic properties as collagenous tissues without lengthening other than increased strain and strength. Notwithstanding different lengthening schemes result in varied viscoelastic properties changes, the most comparable viscoelastic properties to be demonstrated are under the scheme of a distraction rate of 1 mm/day and 20% increase in tibia length.
doi:10.1186/1471-2474-10-105
PMCID: PMC2734753  PMID: 19698092
25.  Validity and reliability of the Dutch translation of the VISA-P questionnaire for patellar tendinopathy 
Background
The VISA-P questionnaire evaluates severity of symptoms, knee function and ability to play sports in athletes with patellar tendinopathy. This English-language self-administered brief patient outcome score was developed in Australia to monitor rehabilitation and to evaluate outcome of clinical studies. Aim of this study was to translate the questionnaire into Dutch and to study the reliability and validity of the Dutch version of the VISA-P.
Methods
The questionnaire was translated into Dutch according to internationally recommended guidelines. Test-retest reliability was determined in 99 students with a time interval of 2.5 weeks. To determine discriminative validity of the Dutch VISA-P, 18 healthy students, 15 competitive volleyball players (at-risk population), 14 patients with patellar tendinopathy, 6 patients who had surgery for patellar tendinopathy, 17 patients with knee injuries other than patellar tendinopathy, and 9 patients with symptoms unrelated to their knees completed the Dutch VISA-P.
Results
The Dutch VISA-P questionnaire showed satisfactory test-retest reliability (ICC = 0.74). The mean (± SD) VISA-P scores were 95 (± 9) for the healthy students, 89 (± 11) for the volleyball players, 58 (± 19) for patients with patellar tendinopathy, and 56 (± 21) for athletes who had surgery for patellar tendinopathy. Patients with other knee injuries or symptoms unrelated to the knee scored 62 (± 24) and 77 (± 24).
Conclusion
The translated Dutch version of the VISA-P questionnaire is equivalent to its original version, has satisfactory test-retest reliability and is a valid score to evaluate symptoms, knee function and ability to play sports of Dutch athletes with patellar tendinopathy.
doi:10.1186/1471-2474-10-102
PMCID: PMC2734752  PMID: 19671174

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