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1.  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.
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.
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.
PMCID: PMC3093401  PMID: 21589875
2.  Should office workers spend fewer hours at their computer? A systematic review of the literature 
Worldwide, millions of office workers use a computer. Reports of adverse health effects due to computer use have received considerable media attention. This systematic review summarises the evidence for a relationship between the duration of work time spent using the computer and the incidence of hand–arm and neck–shoulder symptoms and disorders. Several databases were systematically searched up to 6 November 2005. Two reviewers independently selected articles that presented a risk estimate for the duration of computer use, included an outcome measure related to hand–arm or neck–shoulder symptoms or disorders, and had a longitudinal study design. The strength of the evidence was based on methodological quality and consistency of the results. Nine relevant articles were identified, of which six were rated as high quality. Moderate evidence was concluded for a positive association between the duration of mouse use and hand–arm symptoms. For this association, indications for a dose–response relationship were found. Risk estimates were in general stronger for the hand–arm region than for the neck–shoulder region, and stronger for mouse use than for total computer use and keyboard use. A pathophysiological model focusing on the overuse of muscles during computer use supports these differences. Future studies are needed to improve our understanding of safe levels of computer use by measuring the duration of computer use in a more objective way, differentiating between total computer use, mouse use and keyboard use, attaining sufficient exposure contrast, and collecting data on disability caused by symptoms.
PMCID: PMC2078461  PMID: 17095550
3.  Perceived exertion, comfort and working technique in professional computer users and associations with the incidence of neck and upper extremity symptoms 
The aim of this study was to investigate whether perceived exertion, perceived comfort and working technique is associated with the incidence of neck and upper extremity symptoms among professional computer users.
At baseline a self-administered questionnaire was distributed to 853 participants from 46 different work sites (382 men and 471 women) who, at baseline, had been free from neck and upper extremity symptoms during the preceding month. Work-related exposures, individual factors, and symptoms from the neck and upper extremities were assessed. Observations of working technique were performed by ergonomists using an ergonomic checklist. Incidence data were collected by means of 10 monthly questionnaires, asking for information on the occurrence of neck, shoulder and arm/hand symptoms. Perceived exertion was rated on a modified Borg RPE scale ranging from 0 (very, very light) to 14 (very, very strenuous). Perceived comfort was rated on a 9-point scale ranging from -4 (very, very poor) to +4 (very, very good) in relation to the chair, computer screen, keyboard, and computer mouse.
The median follow up time was 10.3 months. The incidence of symptoms from the neck, shoulders and arm/hands were 50, 24 and 34 cases per 100 person years, respectively.
Higher perceived exertion in the neck, shoulder or arm/hands was associated with an increased risk of developing symptoms in the corresponding body region. Moreover, a dose-response relationship between the level of exertion and the risk of developing symptoms was recorded for all three regions. There was an association between low comfort and an increased risk for neck symptoms, but not for shoulder and arm/hand symptoms, although a trend towards such an association (not statistically significant) could be seen. Working technique was, in this study, not associated with the risk of developing symptoms in any of the investigated body regions.
There was a strong association between high perceived exertion and the development of neck, shoulder, and arm/hand symptoms. Moreover, there was an association between poor perceived comfort and neck pain. Surveillance of computer users may include perceived exertion and comfort to target individuals at risk for neck and upper extremity symptoms.
PMCID: PMC3362766  PMID: 22436251
Computer work; Perceived exertion; Perceived comfort; Working technique; neck and upper extremity disorders
4.  The Burden and Determinants of Neck Pain in Workers 
European Spine Journal  2008;17(Suppl 1):60-74.
Study Design
Systematic review and best evidence synthesis.
To describe the prevalence and incidence of neck pain and disability in workers; to identify risk factors for neck pain in workers; to propose an etiological diagram; and to make recommendations for future research.
Summary of Background Data
Previous reviews of the etiology of neck pain in workers relied on cross-sectional evidence. Recently published cohorts and randomized trials warrant a re-analysis of this body of research.
We systematically searched Medline for literature published from 1980–2006. Retrieved articles were reviewed for relevance. Relevant articles were critically appraised. Articles judged to have adequate internal validity were included in our best evidence synthesis.
One hundred and nine papers on the burden and determinants of neck pain in workers were scientifically admissible. The annual prevalence of neck pain varied from 27.1% in Norway to 47.8% in Québec, Canada. Each year, between 11% and 14.1% of workers were limited in their activities because of neck pain. Risk factors associated with neck pain in workers include age, previous musculoskeletal pain, high quantitative job demands, low social support at work, job insecurity, low physical capacity, poor computer workstation design and work posture, sedentary work position, repetitive work and precision work. We found preliminary evidence that gender, occupation, headaches, emotional problems, smoking, poor job satisfaction, awkward work postures, poor physical work environment, and workers’ ethnicity may be associated with neck pain. There is evidence that interventions aimed at modifying workstations and worker posture are not effective in reducing the incidence of neck pain in workers.
Neck disorders are a significant source of pain and activity limitations in workers. Most neck pain results from complex relationships between individual and workplace risk factors. No prevention strategies have been shown to reduce the incidence of neck pain in workers.
PMCID: PMC2271087
neck pain; work; disability; sick leave; systematic review; epidemiology; incidence; risk factors; etiology
5.  Validity of questionnaire self‐reports on computer, mouse and keyboard usage during a four‐week period 
To examine the validity and potential biases in self‐reports of computer, mouse and keyboard usage times, compared with objective recordings.
A study population of 1211 people was asked in a questionnaire to estimate the average time they had worked with computer, mouse and keyboard during the past four working weeks. During the same period, a software program recorded these activities objectively. The study was part of a one‐year follow‐up study from 2000–1 of musculoskeletal outcomes among Danish computer workers.
Self‐reports on computer, mouse and keyboard usage times were positively associated with objectively measured activity, but the validity was low. Self‐reports explained only between a quarter and a third of the variance of objectively measured activity, and were even lower for one measure (keyboard time). Self‐reports overestimated usage times. Overestimation was large at low levels and declined with increasing levels of objectively measured activity. Mouse usage time proportion was an exception with a near 1:1 relation. Variability in objectively measured activity, arm pain, gender and age influenced self‐reports in a systematic way, but the effects were modest and sometimes in different directions.
Self‐reported durations of computer activities are positively associated with objective measures but they are quite inaccurate. Studies using self‐reports to establish relations between computer work times and musculoskeletal pain could be biased and lead to falsely increased or decreased risk estimates.
PMCID: PMC2078486  PMID: 17387136
6.  Effects of computer keyboarding on ultrasonographic measures of the median nerve 
Keyboarding is a highly repetitive daily task and has been linked to musculoskeletal disorders of the upper extremity. However, the effect of keyboarding on median nerve injuries is not well understood. The purpose of this study was to use ultrasonographic measurements to determine whether continuous keyboarding can cause acute changes in the median nerve.
Ultrasound images of the median nerve from twenty-one volunteers were captured at the levels of the pisiform and distal radius prior to and following a prolonged keyboarding task (i.e., one hour of continuous keyboarding). Images were analyzed by a blinded investigator to quantify the median nerve characteristics. Changes in the median nerve ultrasonographic measures as a result of continuous keyboarding task were evaluated.
Cross-sectional areas at the pisiform level were significantly larger in both dominant (p=0.004) and non-dominant (p=0.001) hands following the keyboarding task. Swelling ratio was significantly greater in the dominant hand (p=0.020) after 60 minutes of keyboarding when compared to the baseline measures. Flattening ratios were not significantly different in either hand as a result of keyboarding.
We were able to detect an acute increase in the area of the median nerve following one hour of keyboarding with a computer keyboard. This suggests that keyboarding has an impact on the median nerve. Further studies are required to understand this relationship, which would provide insight into the pathophysiology of median neuropathies such as carpal tunnel syndrome.
PMCID: PMC4297618  PMID: 21739468
carpal tunnel syndrome; computer keyboarding; median nerve; ultrasonography; ultrasound
7.  Effect of individually tailored biopsychosocial workplace interventions on chronic musculoskeletal pain, stress and work ability among laboratory technicians: randomized controlled trial protocol 
Among laboratory technicians, the prevalence of neck and shoulder pain is widespread possibly due to typical daily work tasks such as pipetting, preparing vial samples for analysis, and data processing on a computer including mouse work - all tasks that require precision in motor control and may result in extended periods of time spent in static positions.
In populations characterized by intense chronic musculoskeletal pain and diagnosed conditions in conjunction with psycho-physiological symptoms such as stress-related pain and soreness and other disabling conditions, multifactorial approaches applying a combination of individually tailored physical and cognitive strategies targeting the areas most needed, may be an effective solution to the physical and mental health challenges.
The aim of this study is therefore to investigate the effect of an individually tailored biopsychosocial intervention strategy on musculoskeletal pain, stress and work disability in lab technicians with a history of musculoskeletal pain at a single worksite in Denmark.
In this single-blind two-armed parallel-group randomized controlled trial with allocation concealment, participants receive either an individualized multifactorial intervention or “usual care” for 10 weeks at the worksite. Inclusion criteria: 1) female laboratory technician (18-67 years of age) and 2) Pain intensity ≥ 3 (0-10 Visual Analogue Scale) lasting ≥3 months with a frequency of ≥ 3 days per week in one or more of the following regions: i) upper back i) low back iii) neck, iv) shoulder, v) elbow and/or vi) hand. Exclusion criteria: 1) life-threatening disease and 2) pregnancy. Stress, as measured by Cohen´s perceived stress questionnaire is not an inclusion criteria, thus participants can participate regardless of their stress level.
We will implement an individualized intervention addressing biopsychosocial elements of musculoskeletal pain with the following components; i) increasing physical capacity through strength- and motor control training; ii) lowering or preventing development of stress through mindfulness practice and learning de-catastrophizing pain management strategies through cognitive training.
The primary outcome at 10-week follow-up is the between-group difference in intensity of perceived musculoskeletal pain during the last week (average value of back, neck, shoulder, elbow and hand) assessed by questionnaire (modified visual analogue scale 0-10).
This study will provide experimental evidence to guide workplace initiatives designed towards reducing chronic musculoskeletal pain and stress.
Trial registration number NCT02047669.
PMCID: PMC4325961  PMID: 25519844
Musculoskeletal disorders; Occupational health and performance; Neck pain; Shoulder pain; Elbow pain; Hand pain; Wrist pain; Repetitive work; Stress; Work ability
8.  Ergonomic Training Reduces Musculoskeletal Disorders among Office Workers: Results from the 6-Month Follow-Up 
Musculoskeletal disorders are commonly reported among computer users. This study explored whether these disorders can be reduced by the provision of ergonomics education.
A cluster randomised controlled trial was conducted in which 3 units were randomised for intervention and received training, and 3 units were given a leaflet. The effect of intervention on workstation habits, musculoskeletal disorders, days and episodes of sick leave, and psychological well-being were assessed.
A significant improvement in workstation habits was found, and the differences remained significant at the follow-up time point for keyboard, mouse, chair, and desk use. The largest reduction in the percentage of musculoskeletal disorders was in the neck region (−42.2%, 95% CI −60.0 to −24.4). After adjusting for baseline values, significant differences were found at the follow-up time point in the neck, right shoulder, right and left upper limbs, lower back, and right and left lower limbs. No significant differences were found for the days and episodes of sick leave or the psychological well-being among workers after the intervention.
Consistent reductions were observed for all musculoskeletal disorders at the follow-up time point, although the difference was not statistically significant for the upper back. The improvements in the musculoskeletal disorders did not translate into fewer days lost from work or improved psychological well-being.
PMCID: PMC3216214  PMID: 22135582
adult; ergonomics; musculoskeletal diseases; occupational health; training
9.  Carpal tunnel syndrome and the use of computer mouse and keyboard: A systematic review 
This review examines evidence for an association between computer work and carpal tunnel syndrome (CTS).
A systematic review of studies of computer work and CTS was performed. Supplementary, longitudinal studies of low force, repetitive work and CTS, and studies of possible pathophysiological mechanisms were evaluated.
Eight epidemiological studies of the association between computer work and CTS were identified. All eight studies had one or more limitation including imprecise exposure and outcome assessment, low statistical power or potentially serious biases. In three of the studies an exposure-response association was observed but because of possible misclassification no firm conclusions could be drawn. Three of the studies found risks below 1. Also longitudinal studies of repetitive low-force non-computer work (n = 3) were reviewed but these studies did not add evidence to an association. Measurements of carpal tunnel pressure (CTP) under conditions typically observed among computer users showed pressure values below levels considered harmful. However, during actual mouse use one study showed an increase of CTP to potentially harmful levels. The long term effects of prolonged or repeatedly increased pressures at these levels are not known, however.
There is insufficient epidemiological evidence that computer work causes CTS.
PMCID: PMC2569035  PMID: 18838001
10.  A randomised controlled trial evaluating the effects of two workstation interventions on upper body pain and incident musculoskeletal disorders among computer operators 
Call centre work with computers is associated with increased rates of upper body pain and musculoskeletal disorders.
This one year, randomised controlled intervention trial evaluated the effects of a wide forearm support surface and a trackball on upper body pain severity and incident musculoskeletal disorders among 182 call centre operators at a large healthcare company. Participants were randomised to receive (1) ergonomics training only, (2) training plus a trackball, (3) training plus a forearm support, or (4) training plus a trackball and forearm support. Outcome measures were weekly pain severity scores and diagnosis of incident musculoskeletal disorder in the upper extremities or the neck/shoulder region based on physical examination performed by a physician blinded to intervention. Analyses using Cox proportional hazard models and linear regression models adjusted for demographic factors, baseline pain levels, and psychosocial job factors.
Post‐intervention, 63 participants were diagnosed with one or more incident musculoskeletal disorders. Hazard rate ratios showed a protective effect of the armboard for neck/shoulder disorders (HR = 0.49, 95% CI 0.24 to 0.97) after adjusting for baseline pain levels and demographic and psychosocial factors. The armboard also significantly reduced neck/shoulder pain (p = 0.01) and right upper extremity pain (p = 0.002) in comparison to the control group. A return‐on‐investment model predicted a full return of armboard and installation costs within 10.6 months.
Providing a large forearm support combined with ergonomic training is an effective intervention to prevent upper body musculoskeletal disorders and reduce upper body pain associated with computer work among call centre employees.
PMCID: PMC2092482  PMID: 16621849
musculoskeletal; computer; upper extremity; intervention; RCT
11.  Incidence of ulnar nerve entrapment at the elbow in repetitive work 
Despite the high frequency of work-related musculoskeletal disorders (WRMD), the relations between working conditions and ulnar nerve entrapment at the elbow (UNEE) has not been the object of much study. We studied the predictive factors for UNEE in a three-year prospective survey of upper-limb WRMD in repetitive work.
In 1993–1994 and three years later, 598 workers whose jobs involve repetitive work were examined by their occupational health physicians and completed a self-administered questionnaire. Predictive factors associated with the onset of UNEE were studied with bivariate and multivariate analysis.
Annual incidence was estimated at 0.8% per person year, based on 15 new cases during this three-year period. Holding a tool in position was the only predictive biomechanical factor (OR = 4.1, CI 1.4–12.0). Obesity increased the risk of UNEE (OR = 4.3, CI 1.2–16.2), as did presence of medial epicondylitis, carpal tunnel syndrome, radial tunnel syndrome, and cervicobrachial neuralgia. The associations with “holding a tool in position” and obesity were unchanged when the presence of other diagnoses was taken into account.
Despite the limitations of the study, the results suggest that UNEE incidence is associated with one biomechanical risk factor (holding a tool in position, repetitively), with overweight, and with other upper-limb WRMD, especially medial epicondylitis and other nerve entrapment disorders (cervicobrachial neuralgia, carpal and radial tunnel syndromes).
PMCID: PMC2988822  PMID: 15250652
Adult; Comorbidity; Cubital Tunnel Syndrome; epidemiology; etiology; Cumulative Trauma Disorders; complications; epidemiology; Female; France; epidemiology; Humans; Incidence; Logistic Models; Male; Middle Aged; Musculoskeletal Diseases; classification; epidemiology; Obesity; complications; Occupational Diseases; complications; epidemiology; Occupations; classification; Posture; physiology; Prospective Studies; Questionnaires; Risk Factors; Workplace; psychology; elbow; repetitive work; ulnar nerve entrapment; work-related musculoskeletal disorder
12.  Cumulative keyboard strokes: a possible risk factor for carpal tunnel syndrome 
Contradictory reports have been published regarding the association of Carpal Tunnel Syndrome (CTS) and the use of computer keyboard. Previous studies did not take into account the cumulative exposure to keyboard strokes among computer workers. The aim of the present study was to investigate the association between cumulative keyboard use (keyboard strokes) and CTS.
Employees (461) from a Governmental data entry & processing unit agreed to participate (response rate: 84.1 %) in a cross-sectional study. Α questionnaire was distributed to the participants to obtain information on socio-demographics and risk factors for CTS. The participants were examined for signs and symptoms related to CTS and were asked if they had previous history or surgery for CTS. The cumulative amount of the keyboard strokes per worker per year was calculated by the use of payroll’s registry. Two case definitions for CTS were used. The first included subjects with personal history/surgery for CTS while the second included subjects that belonged to the first case definition plus those participants were identified through clinical examination.
Multivariate analysis used for both case definitions, indicated that those employees with high cumulative exposure to keyboard strokes were at increased risk of CTS (case definition A: OR = 2.23;95 % CI = 1.09-4.52 and case definition B: OR = 2.41; 95%CI = 1.36-4.25). A dose response pattern between cumulative exposure to keyboard strokes and CTS has been revealed (p < 0.001).
The present study indicated a possible association between cumulative exposure to keyboard strokes and development of CTS. Cumulative exposure to key-board strokes would be taken into account as an exposure indicator regarding exposure assessment of computer workers. Further research is needed in order to test the results of the current study and assess causality between cumulative keyboard strokes and development of CT.
PMCID: PMC3480831  PMID: 22856674
13.  Complaints of the arm, neck and shoulder among computer office workers in Sudan: a prevalence study with validation of an Arabic risk factors questionnaire 
Environmental Health  2008;7:33.
Complaints of the arm, neck and/or shoulders (CANS) in general and computer-related disorders in particular affect millions of computer office workers in Western developed countries. However, with the widespread use of computer systems in developing countries, the associated musculoskeletal complaints are yet to be investigated.
To study the prevalence of work-related CANS, among computer office workers in Sudan, and to test the psychometric properties of a translated Dutch questionnaire in Arabic language.
In 2005 282 computer office workers at a mobile telecommunication company and three banks in Khartoum, Sudan, received an Arabic language version of the validated Maastricht upper extremity questionnaire (MUEQ). The questionnaire holds 109 items covering demographic characteristics, in addition to six main domains (i.e. work station, body posture, break time, job control, job demands and social support) assessing potential physical and psychosocial risk factors. Forward/backward translation of the MUQE was done independently by two different translators. Prevalence over the past year were computed for CANS. Further, the psychometric properties of the Arabic questionnaire were investigated (i.e. factor structure and reliability) and cross-validation was carried out.
The response rate of the questionnaire was 88% (n = 250). The one-year prevalence of CANS showed that 53% of the respondents could be classified as mild cases. The highest incidences were found for neck and shoulder symptoms (64% and 41% respectively). The analysis of the psychometric properties of the scale resulted in the identification of 2 factors for each of the 6 domains (i.e. office equipment, computer position, head and body posture, awkward body posture, autonomy, quality of break time, skill discretion, decision authority, time pressure, task complexity, social support, and work flow). The calculation of internal consistency and cross validation provided evidence of reliability and lack of redundancy of items.
The prevalence of CANS among the targeted population seems to correspond strongly with prevalence of CANS in Western developed countries. The Arabic translation of the MUEQ has satisfactory psychometric properties to be used to assess work-related risk factors for the development of CANS among computer office workers in Sudan.
PMCID: PMC2474607  PMID: 18588691
14.  Differences in prevalence of self-reported musculoskeletal symptoms among computer and non-computer users in a Nigerian population: a cross-sectional study 
Literature abounds on the prevalent nature of Self Reported Musculoskeletal Symptoms (SRMS) among computer users, but studies that actually compared this with non computer users are meagre thereby reducing the strength of the evidence. This study compared the prevalence of SRMS between computer and non computer users and assessed the risk factors associated with SRMS.
A total of 472 participants comprising equal numbers of age and sex matched computer and non computer users were assessed for the presence of SRMS. Information concerning musculoskeletal symptoms and discomforts from the neck, shoulders, upper back, elbows, wrists/hands, low back, hips/thighs, knees and ankles/feet were obtained using the Standardized Nordic questionnaire.
The prevalence of SRMS was significantly higher in the computer users than the non computer users both over the past 7 days (χ2 = 39.11, p = 0.001) and during the past 12 month durations (χ2 = 53.56, p = 0.001). The odds of reporting musculoskeletal symptoms was least for participants above the age of 40 years (OR = 0.42, 95% CI = 0.31-0.64 over the past 7 days and OR = 0.61; 95% CI = 0.47-0.77 during the past 12 months) and also reduced in female participants. Increasing daily hours and accumulated years of computer use and tasks of data processing and designs/graphics significantly (p < 0.05) increased the risk of reporting musculoskeletal symptoms. Over the past 7 day duration, the neck (33.9%) and low back (11.4%) had highest prevalence of SRMS for the computer and non computer users respectively.
The prevalence of SRMS was significantly higher in the computer users than the non computer users and younger age, being male, working longer hours daily, increasing years of computer use, data entry tasks and computer designs/graphics were the significant risk factors for reporting musculoskeletal symptoms among the computer users. Computer use may explain the increase in prevalence of SRMS among the computer users.
PMCID: PMC2927507  PMID: 20691092
15.  Artificial Discs for Lumbar and Cervical Degenerative Disc Disease –Update 
Executive Summary
To assess the safety and efficacy of artificial disc replacement (ADR) technology for degenerative disc disease (DDD).
Clinical Need
Degenerative disc disease is the term used to describe the deterioration of 1 or more intervertebral discs of the spine. The prevalence of DDD is roughly described in proportion to age such that 40% of people aged 40 years have DDD, increasing to 80% among those aged 80 years or older. Low back pain is a common symptom of lumbar DDD; neck and arm pain are common symptoms of cervical DDD. Nonsurgical treatments can be used to relieve pain and minimize disability associated with DDD. However, it is estimated that about 10% to 20% of people with lumbar DDD and up to 30% with cervical DDD will be unresponsive to nonsurgical treatments. In these cases, surgical treatment is considered. Spinal fusion (arthrodesis) is the process of fusing or joining 2 bones and is considered the surgical gold standard for DDD.
Artificial disc replacement is the replacement of the degenerated intervertebral disc with an artificial disc in people with DDD of the lumbar or cervical spine that has been unresponsive to nonsurgical treatments for at least 6 months. Unlike spinal fusion, ADR preserves movement of the spine, which is thought to reduce or prevent the development of adjacent segment degeneration. Additionally, a bone graft is not required for ADR, and this alleviates complications, including bone graft donor site pain and pseudoarthrosis. It is estimated that about 5% of patients who require surgery for DDD will be candidates for ADR.
Review Strategy
The Medical Advisory Secretariat conducted a computerized search of the literature published between 2003 and September 2005 to answer the following questions:
What is the effectiveness of ADR in people with DDD of the lumbar or cervical regions of the spine compared with spinal fusion surgery?
Does an artificial disc reduce the incidence of adjacent segment degeneration (ASD) compared with spinal fusion?
What is the rate of major complications (device failure, reoperation) with artificial discs compared with surgical spinal fusion?
One reviewer evaluated the internal validity of the primary studies using the criteria outlined in the Cochrane Musculoskeletal Injuries Group Quality Assessment Tool. The quality of concealment allocation was rated as: A, clearly yes; B, unclear; or C, clearly no. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A random effects model meta-analysis was conducted when data were available from 2 or more randomized controlled trials (RCTs) and when there was no statistical and or clinical heterogeneity among studies. Bayesian analyses were undertaken to do the following:
Examine the influence of missing data on clinical success rates;
Compute the probability that artificial discs were superior to spinal fusion (on the basis of clinical success rates);
Examine whether the results were sensitive to the choice of noninferiority margin.
Summary of Findings
The literature search yielded 140 citations. Of these, 1 Cochrane systematic review, 1 RCT, and 10 case series were included in this review. Unpublished data from an RCT reported in the grey literature were obtained from the manufacturer of the device. The search also yielded 8 health technology assessments evaluating ADR that are also included in this review.
Six of the 8 health technology assessments concluded that there is insufficient evidence to support the use of either lumbar or cervical ADR. The results of the remaining 2 assessments (one each for lumbar and cervical ADR) led to a National Institute for Clinical Excellence guidance document supporting the safety and effectiveness of lumbar and cervical ADR with the proviso that an ongoing audit of all clinical outcomes be undertaken owing to a lack of long-term outcome data from clinical trials.
Regarding lumbar ADR, data were available from 2 noninferiority RCTs to complete a meta-analysis. The following clinical, health systems, and adverse event outcome measures were synthesized: primary outcome of clinical success, Oswestry Disability Index (ODI) scores, pain VAS scores, patient satisfaction, duration of surgery, amount of blood loss, length of hospital stay, rate of device failure, and rate of reoperation.
The meta-analysis of overall clinical success supported the noninferiority of lumbar ADR compared with spinal fusion at 24-month follow-up. Of the remaining clinical outcome measures (ODI, pain VAS scores, SF-36 scores [mental and physical components], patient satisfaction, and return to work status), only patient satisfaction and scores on the physical component scale of the SF-36 questionnaire were significantly improved in favour of lumbar ADR compared with spinal fusion at 24 months follow-up. Blood loss and surgical time showed statistical heterogeneity; therefore, meta-analysis results are not interpretable. Length of hospital stay was significantly shorter in patients receiving the ADR compared with controls. Neither the number of device failures nor the number of neurological complications at 24 months was statistically significantly different between the ADR and fusion treatment groups. However, there was a trend towards fewer neurological complications at 24 months in the ADR treatment group compared with the spinal fusion treatment group.
Results of the Bayesian analyses indicated that the influence of missing data on the outcome measure of clinical success was minimal. The Bayesian model indicated that the probability for ADR being better than spinal fusion was 79%. The probability of ADR being noninferior to spinal fusion using a -10% noninferiority bound was 92%, and using a -15% noninferiority bound was 94%. The probability of artificial discs being superior to spinal fusion in a future trial was 73%.
Six case series were reviewed, mainly to characterize the rate of major complications for lumbar ADR. The Medical Advisory Secretariat defined a major complication as any reoperation; device failure necessitating a revision, removal or reoperation; or life-threatening event. The rates of major complications ranged from 0% to 13% per device implanted. Only 1 study reported the rate of ASD, which was detected in 2 (2%) of the 100 people 11 years after surgery.
There were no RCT data available for cervical ADR; therefore, data from 4 case series were reviewed for evidence of effectiveness and safety. Because data were sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery. It was found to range from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
The total cost of a lumbar ADR procedure is $15,371 (Cdn; including costs related to the device, physician, and procedure). The total cost of a lumbar fusion surgery procedure is $11,311 (Cdn; including physicians’ and procedural costs).
Lumbar Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, data from 2 RCTs and 6 case series assessing the effectiveness and adverse events profile of lumbar ADR to treat DDD has become available. The GRADE quality of this evidence is moderate for effectiveness and for short-term (2-year follow-up) complications; it is very low for ASD.
The effectiveness of lumbar ADR is not inferior to that of spinal fusion for the treatment of lumbar DDD. The rates for device failure and neurological complications 2 years after surgery did not differ between ADR and fusion patients. Based on a Bayesian meta-analysis, lumbar ADR is 79% superior to lumbar spinal fusion.
The rate of major complications after lumbar ADR is between 0% and 13% per device implanted. The rate of ASD in 1 case series was 2% over an 11-year follow-up period.
Outcome data for lumbar ADR beyond a 2-year follow-up are not yet available.
Cervical Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, 4 case series have been added to the body of evidence assessing the effectiveness and adverse events profile of cervical ADR to treat DDD. The GRADE quality of this evidence is very low for effectiveness as well as for the adverse events profile. Sparse outcome data are available.
Because data are sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery; it ranged from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
PMCID: PMC3379529  PMID: 23074480
16.  Computer work and self-reported variables on anthropometrics, computer usage, work ability, productivity, pain, and physical activity 
Computer users often report musculoskeletal complaints and pain in the upper extremities and the neck-shoulder region. However, recent epidemiological studies do not report a relationship between the extent of computer use and work-related musculoskeletal disorders (WMSD).
The aim of this study was to conduct an explorative analysis on short and long-term pain complaints and work-related variables in a cohort of Danish computer users.
A structured web-based questionnaire including questions related to musculoskeletal pain, anthropometrics, work-related variables, work ability, productivity, health-related parameters, lifestyle variables as well as physical activity during leisure time was designed. Six hundred and ninety office workers completed the questionnaire responding to an announcement posted in a union magazine. The questionnaire outcomes, i.e., pain intensity, duration and locations as well as anthropometrics, work-related variables, work ability, productivity, and level of physical activity, were stratified by gender and correlations were obtained.
Women reported higher pain intensity, longer pain duration as well as more locations with pain than men (P < 0.05). In parallel, women scored poorer work ability and ability to fulfil the requirements on productivity than men (P < 0.05). Strong positive correlations were found between pain intensity and pain duration for the forearm, elbow, neck and shoulder (P < 0.001). Moderate negative correlations were seen between pain intensity and work ability/productivity (P < 0.001).
The present results provide new key information on pain characteristics in office workers. The differences in pain characteristics, i.e., higher intensity, longer duration and more pain locations as well as poorer work ability reported by women workers relate to their higher risk of contracting WMSD. Overall, this investigation confirmed the complex interplay between anthropometrics, work ability, productivity, and pain perception among computer users.
PMCID: PMC3751662  PMID: 23915209
Computer use; Musculoskeletal complaints; Arm-shoulder pain; Gender; Sex
17.  Analyzing musculoskeletal neck pain, measured as present pain and periods of pain, with three different regression models: a cohort study 
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.
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.
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).
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.
PMCID: PMC2714495  PMID: 19545386
18.  Prediction of trapezius muscle activity and shoulder, head, neck, and torso postures during computer use: results of a field study 
Due to difficulties in performing direct measurements as an exposure assessment technique, evidence supporting an association between physical exposures such as neck and shoulder muscle activities and postures and musculoskeletal disorders during computer use is limited. Alternative exposure assessment techniques are needed.
We predicted the median and range of amplitude (90th-10th percentiles) of trapezius muscle activity and the median and range of motion (90th-10th percentiles) of shoulder, head, neck, and torso postures based on two sets of parameters: the distribution of keyboard/mouse/idle activities only (“task-based” predictions), and a comprehensive set of task, questionnaire, workstation, and anthropometric parameters (“expanded model” predictions). We compared the task-based and expanded model predictions based on R2 values, root mean squared (RMS) errors, and relative RMS errors calculated compared to direct measurements.
The expanded model predictions of the median and range of amplitude of trapezius muscle activity had consistently better R2 values (range 0.40-0.55 compared to 0.00-0.06), RMS errors (range 2-3%MVC compared to 3-4%MVC), and relative RMS errors (range 10-14%MVC compared to 16-19%MVC) than the task-based predictions. The expanded model predictions of the median and range of amplitude of postures also had consistently better R2 values (range 0.22-0.58 compared to 0.00-0.35), RMS errors (range 2–14 degrees compared to 3–22 degrees), and relative RMS errors (range 9–21 degrees compared to 13–42 degrees) than the task-based predictions.
The variation in physical exposures across users performing the same task is large, especially in comparison to the variation across tasks. Thus, expanded model predictions of physical exposures during computer use should be used rather than task-based predictions to improve exposure assessment for future epidemiological studies. Clinically, this finding also indicates that computer users will have differences in their physical exposures even when performing the same tasks.
PMCID: PMC4161866  PMID: 25186007
19.  A randomised controlled trial of postural interventions for prevention of musculoskeletal symptoms among computer users 
Aims: To examine the effect of two workstation and postural interventions on the incidence of musculoskeletal symptoms among computer users.
Methods: Randomised controlled trial of two distinct workstation and postural interventions (an alternate intervention and a conventional intervention) among 376 persons using computer keyboards for more than 15 hours per week. The incidence of neck/shoulder symptoms and hand/arm symptoms during six months of follow up among individuals in the intervention groups was compared to the incidence in computer users who did not receive an intervention (comparison group). For individuals in the intervention groups, study staff adjusted workstations, where possible, and trained individuals to assume the intervention postures. Individuals reported musculoskeletal symptoms in a weekly diary. Participants who reported discomfort intensity of 6 or greater on a 0–10 visual analogue scale or who reported musculoskeletal symptoms requiring use of analgesic medication were considered symptomatic.
Results: There were no significant differences in the incidence of musculoskeletal symptoms among the three intervention groups. Twenty two (18.5%) participants in the alternate intervention group, 25 (20.2%) in the conventional intervention group, and 25 (21.7%) in the comparison group developed incident arm or hand symptoms. Thirty eight (33.3%) participants in the alternate intervention group, 36 (31.0%) in the conventional intervention group, and 33 (30.3%) in the comparison group developed incident neck or shoulder symptoms. Compliance with all components of the intervention was attained for only 25–38% of individuals, due mainly to the inflexibility of workstation configurations.
Conclusions: This study provides evidence that two specific workplace postural interventions are unlikely to reduce the risk of upper extremity musculoskeletal symptoms among computer users.
PMCID: PMC1741055  PMID: 15961625
20.  Polysomnography in Patients With Obstructive Sleep Apnea 
Executive Summary
The objective of this health technology policy assessment was to evaluate the clinical utility and cost-effectiveness of sleep studies in Ontario.
Clinical Need: Target Population and Condition
Sleep disorders are common and obstructive sleep apnea (OSA) is the predominant type. Obstructive sleep apnea is the repetitive complete obstruction (apnea) or partial obstruction (hypopnea) of the collapsible part of the upper airway during sleep. The syndrome is associated with excessive daytime sleepiness or chronic fatigue. Several studies have shown that OSA is associated with hypertension, stroke, and other cardiovascular disorders; many researchers believe that these cardiovascular disorders are consequences of OSA. This has generated increasing interest in recent years in sleep studies.
The Technology Being Reviewed
There is no ‘gold standard’ for the diagnosis of OSA, which makes it difficult to calibrate any test for diagnosis. Traditionally, polysomnography (PSG) in an attended setting (sleep laboratory) has been used as a reference standard for the diagnosis of OSA. Polysomnography measures several sleep variables, one of which is the apnea-hypopnea index (AHI) or respiratory disturbance index (RDI). The AHI is defined as the sum of apneas and hypopneas per hour of sleep; apnea is defined as the absence of airflow for ≥ 10 seconds; and hypopnea is defined as reduction in respiratory effort with ≥ 4% oxygen desaturation. The RDI is defined as the sum of apneas, hypopneas, and abnormal respiratory events per hour of sleep. Often the two terms are used interchangeably. The AHI has been widely used to diagnose OSA, although with different cut-off levels, the basis for which are often unclear or arbitrarily determined. Generally, an AHI of more than five events per hour of sleep is considered abnormal and the patient is considered to have a sleep disorder. An abnormal AHI accompanied by excessive daytime sleepiness is the hallmark for OSA diagnosis. For patients diagnosed with OSA, continuous positive airway pressure (CPAP) therapy is the treatment of choice. Polysomnography may also used for titrating CPAP to individual needs.
In January 2005, the College of Physicians and Surgeons of Ontario published the second edition of Independent Health Facilities: Clinical Practice Parameters and Facility Standards: Sleep Medicine, commonly known as “The Sleep Book.” The Sleep Book states that OSA is the most common primary respiratory sleep disorder and a full overnight sleep study is considered the current standard test for individuals in whom OSA is suspected (based on clinical signs and symptoms), particularly if CPAP or surgical therapy is being considered.
Polysomnography in a sleep laboratory is time-consuming and expensive. With the evolution of technology, portable devices have emerged that measure more or less the same sleep variables in sleep laboratories as in the home. Newer CPAP devices also have auto-titration features and can record sleep variables including AHI. These devices, if equally accurate, may reduce the dependency on sleep laboratories for the diagnosis of OSA and the titration of CPAP, and thus may be more cost-effective.
Difficulties arise, however, when trying to assess and compare the diagnostic efficacy of in-home PSG versus in-lab. The AHI measured from portable devices in-home is the sum of apneas and hypopneas per hour of time in bed, rather than of sleep, and the absolute diagnostic efficacy of in-lab PSG is unknown. To compare in-home PSG with in-lab PSG, several researchers have used correlation coefficients or sensitivity and specificity, while others have used Bland-Altman plots or receiver operating characteristics (ROC) curves. All these approaches, however, have potential pitfalls. Correlation coefficients do not measure agreement; sensitivity and specificity are not helpful when the true disease status is unknown; and Bland-Altman plots measure agreement (but are helpful when the range of clinical equivalence is known). Lastly, receiver operating characteristics curves are generated using logistic regression with the true disease status as the dependent variable and test values as the independent variable. Thus, each value of the test is used as a cut-point to measure sensitivity and specificity, which are then plotted on an x-y plane. The cut-point that maximizes both sensitivity and specificity is chosen as the cut-off level to discriminate between disease and no-disease states. In the absence of a gold standard to determine the true disease status, ROC curves are of minimal value.
At the request of the Ontario Health Technology Advisory Committee (OHTAC), MAS has thus reviewed the literature on PSG published over the last two years to examine new developments.
Review Strategy
There is a large body of literature on sleep studies and several reviews have been conducted. Two large cohort studies, the Sleep Heart Health Study and the Wisconsin Sleep Cohort Study, are the main sources of evidence on sleep literature.
To examine new developments on PSG published in the past two years, MEDLINE, EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, the Cochrane Database of Systematic Reviews and Cochrane CENTRAL, INAHTA, and websites of other health technology assessment agencies were searched. Any study that reported results of in-home or in-lab PSG was included. All articles that reported findings from the Sleep Heart Health Study and the Wisconsin Sleep Cohort Study were also reviewed.
Diffusion of Sleep Laboratories
To estimate the diffusion of sleep laboratories, a list of sleep laboratories licensed under the Independent Health Facility Act was obtained. The annual number of sleep studies per 100,000 individuals in Ontario from 2000 to 2004 was also estimated using administrative databases.
Summary of Findings
Literature Review
A total of 315 articles were identified that were published in the past two years; 227 were excluded after reviewing titles and abstracts. A total of 59 articles were identified that reported findings of the Sleep Heart Health Study and the Wisconsin Sleep Cohort Study.
Based on cross-sectional data from the Wisconsin Sleep Cohort Study of 602 men and women aged 30 to 60 years, it is estimated that the prevalence of sleep-disordered breathing is 9% in women and 24% in men, on the basis of more than five AHI events per hour of sleep. Among the women with sleep disorder breathing, 22.6% had daytime sleepiness and among the men, 15.5% had daytime sleepiness. Based on this, the prevalence of OSA in the middle-aged adult population is estimated to be 2% in women and 4% in men.
Snoring is present in 94% of OSA patients, but not all snorers have OSA. Women report daytime sleepiness less often compared with their male counterparts (of similar age, body mass index [BMI], and AHI). Prevalence of OSA tends to be higher in older age groups compared with younger age groups.
Diagnostic Value of Polysomnography
It is believed that PSG in the sleep laboratory is more accurate than in-home PSG. In the absence of a gold standard, however, claims of accuracy cannot be substantiated. In general, there is poor correlation between PSG variables and clinical variables. A variety of cut-off points of AHI (> 5, > 10, and > 15) are arbitrarily used to diagnose and categorize severity of OSA, though the clinical importance of these cut-off points has not been determined.
Recently, a study of the use of a therapeutic trial of CPAP to diagnose OSA was reported. The authors studied habitual snorers with daytime sleepiness in the absence of other medical or psychiatric disorders. Using PSG as the reference standard, the authors calculated the sensitivity of this test to be 80% and its specificity to be 97%. Further, they concluded that PSG could be avoided in 46% of this population.
Obstructive Sleep Apnea and Obesity
Obstructive sleep apnea is strongly associated with obesity. Obese individuals (BMI >30 kg/m2) are at higher risk for OSA compared with non-obese individuals and up to 75% of OSA patients are obese. It is hypothesized that obese individuals have large deposits of fat in the neck that cause the upper airway to collapse in the supine position during sleep. The observations reported from several studies support the hypothesis that AHIs (or RDIs) are significantly reduced with weight loss in obese individuals.
Obstructive Sleep Apnea and Cardiovascular Diseases
Associations have been shown between OSA and comorbidities such as diabetes mellitus and hypertension, which are known risk factors for myocardial infarction and stroke. Patients with more severe forms of OSA (based on AHI) report poorer quality of life and increased health care utilization compared with patients with milder forms of OSA. From animal models, it is hypothesized that sleep fragmentation results in glucose intolerance and hypertension. There is, however, no evidence from prospective studies in humans to establish a causal link between OSA and hypertension or diabetes mellitus. It is also not clear that the associations between OSA and other diseases are independent of obesity; in most of these studies, patients with higher values of AHI had higher values of BMI compared with patients with lower AHI values.
A recent meta-analysis of bariatric surgery has shown that weight loss in obese individuals (mean BMI = 46.8 kg/m2; range = 32.30–68.80) significantly improved their health profile. Diabetes was resolved in 76.8% of patients, hypertension was resolved in 61.7% of patients, hyperlipidemia improved in 70% of patients, and OSA resolved in 85.7% of patients. This suggests that obesity leads to OSA, diabetes, and hypertension, rather than OSA independently causing diabetes and hypertension.
Health Technology Assessments, Guidelines, and Recommendations
In April 2005, the Centers for Medicare and Medicaid Services (CMS) in the United States published its decision and review regarding in-home and in-lab sleep studies for the diagnosis and treatment of OSA with CPAP. In order to cover CPAP, CMS requires that a diagnosis of OSA be established using PSG in a sleep laboratory. After reviewing the literature, CMS concluded that the evidence was not adequate to determine that unattended portable sleep study was reasonable and necessary in the diagnosis of OSA.
In May 2005, the Canadian Coordinating Office of Health Technology Assessment (CCOHTA) published a review of guidelines for referral of patients to sleep laboratories. The review included 37 guidelines and associated reviews that covered 18 applications of sleep laboratory studies. The CCOHTA reported that the level of evidence for many applications was of limited quality, that some cited studies were not relevant to the recommendations made, that many recommendations reflect consensus positions only, and that there was a need for more good quality studies of many sleep laboratory applications.
As of the time of writing, there are 97 licensed sleep laboratories in Ontario. In 2000, the number of sleep studies performed in Ontario was 376/100,000 people. There was a steady rise in sleep studies in the following years such that in 2004, 769 sleep studies per 100,000 people were performed, for a total of 96,134 sleep studies. Based on prevalence estimates of the Wisconsin Sleep Cohort Study, it was estimated that 927,105 people aged 30 to 60 years have sleep-disordered breathing. Thus, there may be a 10-fold rise in the rate of sleep tests in the next few years.
Economic Analysis
In 2004, approximately 96,000 sleep studies were conducted in Ontario at a total cost of ~$47 million (Cdn). Since obesity is associated with sleep disordered breathing, MAS compared the costs of sleep studies to the cost of bariatric surgery. The cost of bariatric surgery is $17,350 per patient. In 2004, Ontario spent $4.7 million per year for 270 patients to undergo bariatric surgery in the province, and $8.2 million for 225 patients to seek out-of-country treatment. Using a Markov model, it was concluded that shifting costs from sleep studies to bariatric surgery would benefit more patients with OSA and may also prevent health consequences related to diabetes, hypertension, and hyperlipidemia. It is estimated that the annual cost of treating comorbid conditions in morbidly obese patients often exceeds $10,000 per patient. Thus, the downstream cost savings could be substantial.
Considerations for Policy Development
Weight loss is associated with a decrease in OSA severity. Treating and preventing obesity would also substantially reduce the economic burden associated with diabetes, hypertension, hyperlipidemia, and OSA. Promotion of healthy weights may be achieved by a multisectorial approach as recommended by the Chief Medical Officer of Health for Ontario. Bariatric surgery has the potential to help morbidly obese individuals (BMI > 35 kg/m2 with an accompanying comorbid condition, or BMI > 40 kg/m2) lose weight. In January 2005, MAS completed an assessment of bariatric surgery, based on which OHTAC recommended an improvement in access to these surgeries for morbidly obese patients in Ontario.
Habitual snorers with excessive daytime sleepiness have a high pretest probability of having OSA. These patients could be offered a therapeutic trial of CPAP to diagnose OSA, rather than a PSG. A majority of these patients are also obese and may benefit from weight loss. Individualized weight loss programs should, therefore, be offered and patients who are morbidly obese should be offered bariatric surgery.
That said, and in view of the still evolving understanding of the causes, consequences and optimal treatment of OSA, further research is warranted to identify which patients should be screened for OSA.
PMCID: PMC3379160  PMID: 23074483
21.  Does McKenzie Therapy Improve Outcomes for Back Pain? 
Journal of Athletic Training  2006;41(1):117-119.
Reference: Clare HA, Adams R, Maher CG. A systematic review of efficacy of McKenzie therapy for spinal pain. Aust J Physiother20045020921615574109.
Clinical Question: What is the clinical evidence base for McKenzie therapy in management of back pain?
Data Sources: Studies were identified using a computer-based literature search of 7 databases: MEDLINE, EMBASE, DARE, CINAHL, PEDro, the Cochrane Register of Clinical Trials (CENTRAL), and the Cochrane Database of Systematic Reviews. Search terms included McKenzie therapy, McKenzie treatment, and McKenzie method. Studies published before September 2003 were eligible.
Study Selection: To be included in the review, each study had to fulfill the following criteria: (1) the study was a randomized or quasi-randomized controlled trial, (2) the subjects' primary complaint was nonspecific low back pain or neck pain with or without radiation to the extremities, (3) the authors investigated the efficacy of the McKenzie method/McKenzie treatment in comparison with no treatment, sham treatment, or another treatment, (4) individualized patient treatment and treatment were specified according to McKenzie principles, and (5) the authors reported at least one of the outcome measures of pain, disability, quality of life, work status, global perceived effect, medication use, medical visits, or recurrence. Studies were included with no language restriction and with subjects of all age groups, of either sex, and with any duration of symptoms. Studies were excluded if subjects had any of the following spinal conditions: cauda equina syndrome, cord compression, infection, fracture, neoplasm, inflammatory disease, pregnancy, any form of headache, whiplash-associated disorders, vertigo/dizziness, or vertebrobasilar insufficiency.
Data Extraction: Data were independently extracted from each study by 2 investigators using a standardized data extraction form. The standardized data extraction form and experience level of the investigators were not included in the review. In studies with more than 2 treatment groups, the treatment contrast of more relevance to current Australian physiotherapy was selected.
Data were also extracted for short-, intermediate-, and long-term follow-up based on the criteria suggested by the Cochrane Back Review Group. Short-term follow-up was defined as less than 3 months from onset of treatment. Intermediate-term follow-up was defined as at least 3 months and less than 12 months from onset of treatment. Long-term follow-up was defined as equal to or greater than 12 months.
All eligible studies were rated for methodologic quality using the PEDro scale. The PEDro scale is a checklist that examines the “believability and the interpretability of trial quality.”1 The 11-item checklist yields a maximum score of 10 if all criteria are satisfied. The first item on the scale (Eligibility Criteria) is not scored. The PEDro scores were extracted from the PEDro database. If a study had not been entered into the database and scored, it was reviewed and scored by an experienced PEDro rater.
Main Results: Normalized data for pain and disability were given possible total scores of 100. The article's scores on the PEDro scale were average, ranging from 4 to 8 of 10. The most common flaw in the methods, which occurred in all 6 studies, was the failure to blind both the patient and therapist. Four of the 6 did not blind the researcher interpreting the data. For both pain and disability at short-term (<3 months) follow-up, individual study results for low back pain favored McKenzie therapy compared with the following: nonsteroidal anti-inflammatory drugs, educational booklet, back massage with back care advice, strength training with therapist supervision, spinal mobilization, or general mobility exercises. Trends favored McKenzie therapy at intermediate-term (3–12 months) follow-up for pain and disability, as well as work absences. The McKenzie treatment group in the cervical spine study had less pain and disability at both short- and intermediate-term follow-up than did the exercise group, although the effect sizes were small. The same McKenzie treatment group tended to have fewer health care contacts in the ensuing 12 months than the comparison exercise group.
The results suggest that McKenzie therapy provides a reduction in short-term pain (mean reduction of 8.6 on a 100-point scale) compared with the therapies mentioned above. A second (sensitivity) analysis was conducted to include data from 3 studies that were initially excluded because of lack of individualized treatment. The sensitivity analysis was used to determine if the exclusion of these studies would significantly alter the conclusion of the review. Instead, the sensitivity analysis strengthened the evidence supporting the notion that McKenzie therapy is more effective in short-term pain relief than other therapies (reduction of 11.4 on a 100-point scale).
Conclusions: This review provides evidence that McKenzie therapy results in a decrease in short-term (<3 months) pain and disability for low back pain patients compared with other standard treatments, such as nonsteroidal anti-inflammatory drugs, educational booklet, back massage with back care advice, strength training with therapist supervision, and spinal mobilization. No statistical differences were found between McKenzie therapy and other therapies at intermediate-term (3–12 months) follow-up. Data are insufficient on long-term (>12 months) outcomes or outcomes other than pain and disability (eg, quality of life). To date, no authors have compared McKenzie therapy with placebo or no treatment. Also, few data are available on the McKenzie method and its effect on neck pain. Future researchers should focus on these issues.
PMCID: PMC1421491  PMID: 16619104
spine; rehabilitation
22.  Mechanistic experimental pain assessment in computer users with and without chronic musculoskeletal pain 
Musculoskeletal pain from the upper extremity and shoulder region is commonly reported by computer users. However, the functional status of central pain mechanisms, i.e., central sensitization and conditioned pain modulation (CPM), has not been investigated in this population. The aim was to evaluate sensitization and CPM in computer users with and without chronic musculoskeletal pain.
Pressure pain threshold (PPT) mapping in the neck-shoulder (15 points) and the elbow (12 points) was assessed together with PPT measurement at mid-point in the tibialis anterior (TA) muscle among 47 computer users with chronic pain in the upper extremity and/or neck-shoulder pain (pain group) and 17 pain-free computer users (control group). Induced pain intensities and profiles over time were recorded using a 0-10 cm electronic visual analogue scale (VAS) in response to different levels of pressure stimuli on the forearm with a new technique of dynamic pressure algometry. The efficiency of CPM was assessed using cuff-induced pain as conditioning pain stimulus and PPT at TA as test stimulus.
The demographics, job seniority and number of working hours/week using a computer were similar between groups. The PPTs measured at all 15 points in the neck-shoulder region were not significantly different between groups. There were no significant differences between groups neither in PPTs nor pain intensity induced by dynamic pressure algometry. No significant difference in PPT was observed in TA between groups. During CPM, a significant increase in PPT at TA was observed in both groups (P < 0.05) without significant differences between groups. For the chronic pain group, higher clinical pain intensity, lower PPT values from the neck-shoulder and higher pain intensity evoked by the roller were all correlated with less efficient descending pain modulation (P < 0.05).
This suggests that the excitability of the central pain system is normal in a large group of computer users with low pain intensity chronic upper extremity and/or neck-shoulder pain and that increased excitability of the pain system cannot explain the reported pain. However, computer users with higher pain intensity and lower PPTs were found to have decreased efficiency in descending pain modulation.
PMCID: PMC4265505  PMID: 25481709
Sensitization; Pain mechanisms; Computer work; Conditioned pain modulation; Work-related musculoskeletal disorders; Pressure pain threshold; Experimental pain
23.  Stenting for Peripheral Artery Disease of the Lower Extremities 
Executive Summary
In January 2010, the Medical Advisory Secretariat received an application from University Health Network to provide an evidentiary platform on stenting as a treatment management for peripheral artery disease. The purpose of this health technology assessment is to examine the effectiveness of primary stenting as a treatment management for peripheral artery disease of the lower extremities.
Clinical Need: Condition and Target Population
Peripheral artery disease (PAD) is a progressive disease occurring as a result of plaque accumulation (atherosclerosis) in the arterial system that carries blood to the extremities (arms and legs) as well as vital organs. The vessels that are most affected by PAD are the arteries of the lower extremities, the aorta, the visceral arterial branches, the carotid arteries and the arteries of the upper limbs. In the lower extremities, PAD affects three major arterial segments i) aortic-iliac, ii) femoro-popliteal (FP) and iii) infra-popliteal (primarily tibial) arteries. The disease is commonly classified clinically as asymptomatic claudication, rest pain and critical ischemia.
Although the prevalence of PAD in Canada is not known, it is estimated that 800,000 Canadians have PAD. The 2007 Trans Atlantic Intersociety Consensus (TASC) II Working Group for the Management of Peripheral Disease estimated that the prevalence of PAD in Europe and North America to be 27 million, of whom 88,000 are hospitalizations involving lower extremities. A higher prevalence of PAD among elderly individuals has been reported to range from 12% to 29%. The National Health and Nutrition Examination Survey (NHANES) estimated that the prevalence of PAD is 14.5% among individuals 70 years of age and over.
Modifiable and non-modifiable risk factors associated with PAD include advanced age, male gender, family history, smoking, diabetes, hypertension and hyperlipidemia. PAD is a strong predictor of myocardial infarction (MI), stroke and cardiovascular death. Annually, approximately 10% of ischemic cardiovascular and cerebrovascular events can be attributed to the progression of PAD. Compared with patients without PAD, the 10-year risk of all-cause mortality is 3-fold higher in patients with PAD with 4-5 times greater risk of dying from cardiovascular event. The risk of coronary heart disease is 6 times greater and increases 15-fold in patients with advanced or severe PAD. Among subjects with diabetes, the risk of PAD is often severe and associated with extensive arterial calcification. In these patients the risk of PAD increases two to four fold. The results of the Canadian public survey of knowledge of PAD demonstrated that Canadians are unaware of the morbidity and mortality associated with PAD. Despite its prevalence and cardiovascular risk implications, only 25% of PAD patients are undergoing treatment.
The diagnosis of PAD is difficult as most patients remain asymptomatic for many years. Symptoms do not present until there is at least 50% narrowing of an artery. In the general population, only 10% of persons with PAD have classic symptoms of claudication, 40% do not complain of leg pain, while the remaining 50% have a variety of leg symptoms different from classic claudication. The severity of symptoms depends on the degree of stenosis. The need to intervene is more urgent in patients with limb threatening ischemia as manifested by night pain, rest pain, ischemic ulcers or gangrene. Without successful revascularization those with critical ischemia have a limb loss (amputation) rate of 80-90% in one year.
Diagnosis of PAD is generally non-invasive and can be performed in the physician offices or on an outpatient basis in a hospital. Most common diagnostic procedure include: 1) Ankle Brachial Index (ABI), a ratio of the blood pressure readings between the highest ankle pressure and the highest brachial (arm) pressure; and 2) Doppler ultrasonography, a diagnostic imaging procedure that uses a combination of ultrasound and wave form recordings to evaluate arterial flow in blood vessels. The value of the ABI can provide an assessment of the severity of the disease. Other non invasive imaging techniques include: Computed Tomography (CT) and Magnetic Resonance Angiography (MRA). Definitive diagnosis of PAD can be made by an invasive catheter based angiography procedure which shows the roadmap of the arteries, depicting the exact location and length of the stenosis / occlusion. Angiography is the standard method against which all other imaging procedures are compared for accuracy.
More than 70% of the patients diagnosed with PAD remain stable or improve with conservative management of pharmacologic agents and life style modifications. Significant PAD symptoms are well known to negatively influence an individual quality of life. For those who do not improve, revascularization methods either invasive or non-invasive can be used to restore peripheral circulation.
Technology Under Review
A Stent is a wire mesh “scaffold” that is permanently implanted in the artery to keep the artery open and can be combined with angioplasty to treat PAD. There are two types of stents: i) balloon-expandable and ii) self expandable stents and are available in varying length. The former uses an angioplasty balloon to expand and set the stent within the arterial segment. Recently, drug-eluting stents have been developed and these types of stents release small amounts of medication intended to reduce neointimal hyperplasia, which can cause re-stenosis at the stent site. Endovascular stenting avoids the problem of early elastic recoil, residual stenosis and flow limiting dissection after balloon angioplasty.
Research Questions
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), is primary stenting more effective than percutaneous transluminal angioplasty (PTA) in improving patency?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), does primary stenting provide immediate success compared to PTA?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), is primary stenting associated with less complications compared to PTA?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), does primary stenting compared to PTA reduce the rate of re-intervention?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion) is primary stenting more effective than PTA in improving clinical and hemodynamic success?
Are drug eluting stents more effective than bare stents in improving patency, reducing rates of re-interventions or complications?
Research Methods
Literature Search
A literature search was performed on February 2, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA). 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. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Inclusion Criteria
English language full-reports from 1950 to January Week 3, 2010
Comparative randomized controlled trials (RCTs), systematic reviews and meta-analyses of RCTs
Proven diagnosis of PAD of the lower extremities in all patients.
Adult patients at least 18 years of age.
Stent as at least one treatment arm.
Patency, re-stenosis, re-intervention, technical success, hemodynamic (ABI) and clinical improvement and complications as at least an outcome.
Exclusion Criteria
Non-randomized studies
Observational studies (cohort or retrospective studies) and case report
Feasibility studies
Studies that have evaluated stent but not as a primary intervention
Outcomes of Interest
The primary outcome measure was patency. Secondary measures included technical success, re-intervention, complications, hemodynamic (ankle brachial pressure index, treadmill walking distance) and clinical success or improvement according to Rutherford scale. It was anticipated, a priori, that there would be substantial differences among trials regarding the method of examination and definitions of patency or re-stenosis. Where studies reported only re-stenosis rates, patency rates were calculated as 1 minus re-stenosis rates.
Statistical Analysis
Odds ratios (for binary outcomes) or mean difference (for continuous outcomes) with 95% confidence intervals (CI) were calculated for each endpoint. An intention to treat principle (ITT) was used, with the total number of patients randomized to each study arm as the denominator for each proportion. Sensitivity analysis was performed using per protocol approach. A pooled odds ratio (POR) or mean difference for each endpoint was then calculated for all trials reporting that endpoint using a fixed effects model. PORs were calculated for comparisons of primary stenting versus PTA or other alternative procedures. Level of significance was set at alpha=0.05. Homogeneity was assessed using the chi-square test, I2 and by visual inspection of forest plots. If heterogeneity was encountered within groups (P < 0.10), a random effects model was used. All statistical analyses were performed using RevMan 5. Where sufficient data were available, these analyses were repeated within subgroups of patients defined by time of outcome assessment to evaluate sustainability of treatment benefit. Results were pooled based on the diseased artery and stent type.
Summary of Findings
Balloon-expandable stents vs PTA in superficial femoral artery disease
Based on a moderate quality of evidence, there is no significant difference in patency between primary stenting using balloon-expandable bare metal stents and PTA at 6, 12 and 24 months in patients with superficial femoral artery disease. The pooled OR for patency and their corresponding 95% CI are: 6 months 1.26 (0.74, 2.13); 12 months 0.95 (0.66, 1.38); and 24 months 0.72 (0.34. 1.55).
There is no significant difference in clinical improvement, re-interventions, peri and post operative complications, mortality and amputations between primary stenting using balloon-expandable bare stents and PTA in patients with superficial femoral artery. The pooled OR and their corresponding 95% CI are clinical improvement 0.85 (0.50, 1.42); ankle brachial index 0.01 (-0.02, 0.04) re-intervention 0.83 (0.26, 2.65); complications 0.73 (0.43, 1.22); all cause mortality 1.08 (0.59, 1.97) and amputation rates 0.41 (0.14, 1.18).
Self-expandable stents vs PTA in superficial femoral artery disease
Based on a moderate quality of evidence, primary stenting using self-expandable bare metal stents is associated with significant improvement in patency at 6, 12 and 24 months in patients with superficial femoral artery disease. The pooled OR for patency and their corresponding 95% CI are: 6 months 2.35 (1.06, 5.23); 12 months 1.54 (1.01, 2.35); and 24 months 2.18 (1.00. 4.78). However, the benefit of primary stenting is not observed for clinical improvement, re-interventions, peri and post operative complications, mortality and amputation in patients with superficial femoral artery disease. The pooled OR and their corresponding 95% CI are clinical improvement 0.61 (0.37, 1.01); ankle brachial index 0.01 (-0.06, 0.08) re-intervention 0.60 (0.36, 1.02); complications 1.60 (0.53, 4.85); all cause mortality 3.84 (0.74, 19.22) and amputation rates 1.96 (0.20, 18.86).
Balloon expandable stents vs PTA in iliac artery occlusive disease
Based on moderate quality of evidence, despite immediate technical success, 12.23 (7.17, 20.88), primary stenting is not associated with significant improvement in patency, clinical status, treadmill walking distance and reduction in re-intervention, complications, cardiovascular events, all cause mortality, QoL and amputation rates in patients with intermittent claudication caused by iliac artery occlusive disease. The pooled OR and their corresponding 95% CI are: patency 1.03 (0.56, 1.87); clinical improvement 1.08 (0.60, 1.94); walking distance 3.00 (12.96, 18.96); re-intervention 1.16 (0.71, 1.90); complications 0.56 (0.20, 1.53); all cause mortality 0.89 (0.47, 1.71); QoL 0.40 (-4.42, 5.52); cardiovascular event 1.16 (0.56, 2.40) and amputation rates 0.37 (0.11, 1.23). To date no RCTs are available evaluating self-expandable stents in the common or external iliac artery stenosis or occlusion.
Drug-eluting stent vs balloon-expandable bare metal stents in crural arteries
Based on a very low quality of evidence, at 6 months of follow-up, sirolimus drug-eluting stents are associated with a reduction in target vessel revascularization and re-stenosis rates in patients with atherosclerotic lesions of crural (tibial) arteries compared with balloon-expandable bare metal stent. The OR and their corresponding 95% CI are: re-stenosis 0.09 (0.03, 0.28) and TVR 0.15 (0.05, 0.47) in patients with atherosclerotic lesions of the crural arteries at 6 months follow-up. Both types of stents offer similar immediate success. Limitations of this study include: short follow-up period, small sample and no assessment of mortality as an outcome. Further research is needed to confirm its effect and safety.
PMCID: PMC3377569  PMID: 23074395
24.  Psychological factors at work and musculoskeletal disorders: a one year prospective study 
Rheumatology International  2013;33(12):2975-2983.
The etiology of musculoskeletal disorders is complex, with physical and psychosocial working conditions playing an important role. This study aimed to determine the relationship between psychosocial work conditions, such as psychological job demands, decision latitude, social support and job insecurity and musculoskeletal complains (MSCs) and (repetitive strain injuries (RSIs) in a 1-year prospective study. The job content questionnaire, the Nordic musculoskeletal questionnaire and provocation tests were used to study 725 employees aged 20–70 years. Pain in the lower back (58 % of subjects), neck (57 %), wrists/hands (47 %) and upper back (44 %) was most frequent. The carpal tunnel syndrome (CTS) (33.6 %), rotator cuff tendinitis (15.4 %), Guyon’s canal syndrome (13.4 %), lateral epicondylitis (7.6 %), medial epicondylitis (5.3 %), tendinitis of forearm–wrist extensors (7.8 %) and tendinitis of forearm–wrist flexors (7.3 %) were the most frequent RSIs. Logistic analysis showed that increased psychological job demands statistically significantly increased the probability of lateral and medial epicondylitis, and increased control (decision latitude) statistically significantly decreased the risk of CTS. There was no relationship between job insecurity, social support and the studied RSIs. Psychosocial factors at work predict prevalence of MSCs and RSIs, irrespectively of demographic factors, e.g., age or gender, and organizational and physical factors.
PMCID: PMC3832752  PMID: 23934521
MSDs; Psychosocial factors; Work demands
25.  Risk factors for carpal tunnel syndrome in a general population. 
OBJECTIVE: To determine the individual, physical, and psychosocial risk factors for carpal tunnel syndrome in a general population. METHODS: Population based case-control study in Marshfield epidemiological study area in Wisconsin, USA. Cases were men and women aged 18-69 with newly diagnosed carpal tunnel syndrome (n = 206 (83.1%) of 248 eligible). Controls were a random sample of residents of the study area who had no history of diagnosed carpal tunnel syndrome (n = 211 (81.5%) of 259 eligible). Cases and controls were matched by age. Telephone interviews and reviews of medical records obtained height and weight, medical history, average daily hours of exposure to selected physical and organisational work factors, and self ratings on psychosocial work scales. RESULTS: In the final logistic regression model, five work and three non-work variables were associated with risk of carpal tunnel syndrome, after adjusting for age. For each one unit of increase in body mass index (kg/m2), risk increased 8% (odds ratio (OR) 1.08; 95% confidence interval (95% CI) 1.03 to 1.14). Having a previous musculoskeletal condition was positively associated with carpal tunnel syndrome (OR 2.54; 95% CI 1.03 to 6.23). People reporting the least influence at work had 2.86 times the risk (95% CI, 1.10 to 7.14) than those with the most influence at work. CONCLUSIONS: Carpal tunnel syndrome is a work related disease, although some important measures of occupational exposure, including keyboard use, were not risk factors in this general population study. The mechanism whereby a weight gain of about six pounds increases the risk of disease 8% requires explanation.
PMCID: PMC1128928  PMID: 9404321

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