A systematic review of interventions aimed at increasing physical activity in adults with chronic musculoskeletal pain-protocol

Background: Chronic musculoskeletal pain is highly prevalent, affecting around one in five people across Europe. Osteoarthritis, low back pain, neck pain and other musculoskeletal disorders are leading causes of disability
worldwide and the most common source of chronic pain. Exercise and/or physical activity interventions have the potential to address not only the pain and disability associated with chronic pain but also the increased risk of morbidity and mortality seen in this population. Although exercise and/or physical activity is widely recommended, there is currently a paucity of research that offers an evidence base upon which the development or optimisation of interventions can be based. This systematic review will investigate the components of interventions associated with changes in physical activity levels in adults with chronic musculoskeletal pain.

Methods/Design: This systematic review will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidance. Randomised and quasi-randomised controlled trials of interventions aimed at increasing physical activity in adults with chronic musculoskeletal pain will be included. Articles will be identified through a comprehensive search of the following databases: CENTRAL in the Cochrane Library, the Cochrane Database of Systematic Reviews (CDSR), MEDLINE, Embase, CINAHL, PsycINFO and AMED. Two review authors will independently screen articles retrieved from the search for eligibility, extract relevant data on methodological issues and code interventions according to the behaviour change technique taxonomy (v1) of 93 hierarchically clustered techniques. As complex healthcare interventions can be modified by a wide variety of factors, data will be summarised statistically when the data are available, are sufficiently similar and are of sufficient quality. A narrative synthesis will be completed if there is insufficient data to permit a formal meta-analysis.

Discussion: This review will be of value to clinicians working in chronic pain services and to researchers involved in designing and evaluating interventions.

Walking Exercise for Chronic Musculoskeletal Pain: Systematic Review and Meta-Analysis

Objective: To systematically review the evidence examining effects of walking interventions on pain and self-reported function in individuals with chronic musculoskeletal pain.
Data Sources: Six electronic databases (Medline, CINAHL, PsychINFO, PEDro, Sport Discus and the Cochrane Central Register of Controlled Trials) were searched from January 1980 up to March 2014.
Study Selection: Randomized and quasi-randomized controlled trials in adults with chronic low back pain, osteoarthritis or fibromyalgia comparing walking interventions to a non-exercise or non-walking exercise control group.
Data Extraction: Data were independently extracted using a standardized form. Methodological quality was assessed using the United States Preventative Services Task Force (USPSTF) system.
Data Synthesis: Twenty-six studies (2384 participants) were included and suitable data from 17 were pooled for meta-analysis with a random effects model used to calculate between group mean differences and 95% confidence intervals. Data were analyzed according to length of follow-up (short-term: ≤8 weeks post randomization; medium-term: >2 months - 12 months; long-term: > 12 months). Interventions were associated with small to moderate improvements in pain at short (mean difference (MD) -5.31, 95% confidence interval (95% CI) -8.06 to -2.56) and medium-term follow-up (MD -7.92, 95% CI -12.37 to -3.48). Improvements in function were observed at short (MD -6.47, 95% CI -12.00 to -0.95), medium (MD -9.31, 95% CI -14.00 to -4.61) and long-term follow-up (MD -5.22, 95% CI 7.21 to -3.23).
Conclusions: Evidence of fair methodological quality suggests that walking is associated with significant improvements in outcome compared to control interventions but longer-term effectiveness is uncertain. Using the USPSTF system, walking can be recommended as an effective form of exercise or activity for individuals with chronic musculoskeletal pain but should be supplemented with strategies aimed at maintaining participation. Further work is also required examining effects on important health related outcomes in this population in robustly designed studies.

Supervised walking in comparison with fitness training for chronic back pain in physiotherapy: results of the SWIFT single-blinded randomized controlled trial (ISRCTN17592092)

Effectiveness of brief/minimal contact self-activation interventions that encourage participation in physical activity (PA) for chronic low back pain (CLBP >12 weeks) is unproven. The primary objective of this assessor-blinded randomized controlled trial was to investigate the difference between an individualized walking programme (WP), group exercise class (EC), and usual physiotherapy (UP, control) in mean change in functional disability at 6 months. A sample of 246 participants with CLBP aged 18 to 65 years (79 men and 167 women; mean age ± SD: 45.4 ± 11.4 years) were recruited from 5 outpatient physiotherapy departments in Dublin, Ireland. Consenting participants completed self-report measures of functional disability, pain, quality of life, psychosocial beliefs, and PA were randomly allocated to the WP (n = 82), EC (n = 83), or UP (n = 81) and followed up at 3 (81%; n = 200), 6 (80.1%; n = 197), and 12 months (76.4%; n = 188). Cost diaries were completed at all follow-ups. An intention-to-treat analysis using a mixed between-within repeated-measures analysis of covariance found significant improvements over time on the Oswestry Disability Index (Primary Outcome), the Numerical Rating Scale, Fear Avoidance-PA scale, and the EuroQol EQ-5D-3L Weighted Health Index (P < 0.05), but no significant between-group differences and small between-group effect sizes (WP: mean difference at 6 months, 6.89 Oswestry Disability Index points, 95% confidence interval [CI] -3.64 to -10.15; EC: -5.91, CI: -2.68 to -9.15; UP: -5.09, CI: -1.93 to -8.24). The WP had the lowest mean costs and the highest level of adherence. Supervised walking provides an effective alternative to current forms of CLBP management.

SYSTEMATIC REVIEW AND META-ANALYSIS: EFFECTS OF WALKING EXERCISE IN CHRONIC MUSCULOSKELETAL PAIN

SYSTEMATIC REVIEW AND META-ANALYSIS: EFFECTS OF WALKING EXERCISE IN CHRONIC MUSCULOSKELETAL PAIN O'Connor S.R.1, Tully M.A.2, Ryan B.3, Baxter D.G.3, Bradley J.M.1, McDonough S.M.11University of Ulster, Health & Rehabilitation Sciences Research Institute, Newtownabbey, United Kingdom, 2Queen's University, UKCRC Centre of Excellence for Public Health (NI), Belfast, United Kingdom, 3University of Otago, Centre for Physiotherapy Research, Dunedin, New ZealandPurpose: To examine the effects of walking exercise on pain and self-reported function in adults with chronic musculoskeletal pain.Relevance: Chronic musculoskeletal pain is a major cause of morbidity, exerting a substantial influence on long-term health status and overall quality of life. Current treatment recommendations advocate various aerobic exercise interventions for such conditions. Walking may represent an ideal form of exercise due to its relatively low impact. However, there is currently limited evidence for its effectiveness.Participants: Not applicable.Methods: A comprehensive search strategy was undertaken by two independent reviewers according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) and the recommendations of the Cochrane Musculoskeletal Review Group. Six electronic databases (Medline, CINAHL, PsychINFO, PEDro, Sport DISCUS and the Cochrane Central Register of Controlled Trials) were searched for relevant papers published up to January 2010 using MeSH terms. All randomised or non-randomised studies published in full were considered for inclusion. Studies were required to include adults aged 18 years or over with a diagnosis of chronic low back pain, osteoarthritis or fibromyalgia. Studies were excluded if they involved peri-operative or post-operative interventions or did not include a comparative, non exercise or non-walking exercise control group. The U.S. Preventative Services Task Force system was used to assess methodological quality. Data for pain and self-reported function were extracted and converted to a score out of 100.Analysis: Data were pooled and analyzed using RevMan (v.5.0.24). Statistical heterogeneity was assessed using the X2 and I2 test statistics. A random effects model was used to calculate the mean differences and 95% CIs. Data were analyzed by length of final follow-up which was categorized as short (≤8 weeks post randomisation), mid (2-12 months) or long-term (>12 months).Results: A total of 4324 articles were identified and twenty studies (1852 participants) meeting the inclusion criteria were included in the review. Overall, studies were judged to be of at least fair methodological quality. The most common sources of likely bias were identified as lack of concealed allocation and failure to adequately address incomplete data. Data from 12 studies were suitable for meta-analysis. Walking led to reductions in pain at short (<8 weeks post randomisation) (-8.44 [-14.54, -2.33]) and mid-term (>8 weeks - 12 month) follow-up (-9.28 [-16.34, -2.22]). No effect was observed for long-term (>12 month) data (-2.49 [-7.62, 2.65]). For function, between group differences were observed for short (-11.57 [-16.06, -7.08]) and mid-term data (-13.26 [-16.91, -9.62]). A smaller effect was also observed at long-term follow-up (-5.60 [-7.70, -3.50]).Conclusions: Walking interventions were associated with statistically significant improvements in pain and function at short and mid-term follow-up. Long-term data were limited but indicated that these effects do not appear to be maintained beyond twelve months.Implications: Walking may be an effective form of exercise for individuals with chronic musculoskeletal pain. However, further research is required which examines longer term follow-up and dose-response issues in this population.Key-words: 1. Walking exercise 2. Musculoskeletal pain 3. Systematic reviewFunding acknowledgements: Department of Employment and Learning, Northern Ireland.Ethics approval: Not applicable.

A review of behaviour change theories and techniques used in group based self-management programmes for chronic low back pain and arthritis

Background: Medical Research Council (MRC) guidelines recommend applying theory within complex interventions to explain how behaviour change occurs. Guidelines endorse self-management of chronic low back pain (CLBP) and osteoarthritis (OA), but evidence for its effectiveness is weak. Objective: This literature review aimed to determine the use of behaviour change theory and techniques within randomised controlled trials of group-based self-management programmes for chronic musculoskeletal pain, specifically CLBP and OA. Methods: A two-phase search strategy of electronic databases was used to identify systematic reviews and studies relevant to this area. Articles were coded for their use of behaviour change theory, and the number of behaviour change techniques (BCTs) was identified using a 93-item taxonomy, Taxonomy (v1). Results: 25 articles of 22 studies met the inclusion criteria, of which only three reported having based their intervention on theory, and all used Social Cognitive Theory. A total of 33 BCTs were coded across all articles with the most commonly identified techniques being '. instruction on how to perform the behaviour', '. demonstration of the behaviour', '. behavioural practice', '. credible source', '. graded tasks' and '. body changes'. Conclusion: Results demonstrate that theoretically driven research within group based self-management programmes for chronic musculoskeletal pain is lacking, or is poorly reported. Future research that follows recommended guidelines regarding the use of theory in study design and reporting is warranted.

Failure of a numerical quality assessment scale to identify potential risk of bias in a systematic review: a comparison study

BACKGROUND: Assessing methodological quality of primary studies is an essential component of systematic reviews. Following a systematic review which used a domain based system [United States Preventative Services Task Force (USPSTF)] to assess methodological quality, a commonly used numerical rating scale (Downs and Black) was also used to evaluate the included studies and comparisons were made between quality ratings assigned using the two different methods. Both tools were used to assess the 20 randomized and quasi-randomized controlled trials examining an exercise intervention for chronic musculoskeletal pain which were included in the review. Inter-rater reliability and levels of agreement were determined using intraclass correlation coefficients (ICC). Influence of quality on pooled effect size was examined by calculating the between group standardized mean difference (SMD).

RESULTS: Inter-rater reliability indicated at least substantial levels of agreement for the USPSTF system (ICC 0.85; 95% CI 0.66, 0.94) and Downs and Black scale (ICC 0.94; 95% CI 0.84, 0.97). Overall level of agreement between tools (ICC 0.80; 95% CI 0.57, 0.92) was also good. However, the USPSTF system identified a number of studies (n = 3/20) as "poor" due to potential risks of bias. Analysis revealed substantially greater pooled effect sizes in these studies (SMD -2.51; 95% CI -4.21, -0.82) compared to those rated as "fair" (SMD -0.45; 95% CI -0.65, -0.25) or "good" (SMD -0.38; 95% CI -0.69, -0.08).

CONCLUSIONS: In this example, use of a numerical rating scale failed to identify studies at increased risk of bias, and could have potentially led to imprecise estimates of treatment effect. Although based on a small number of included studies within an existing systematic review, we found the domain based system provided a more structured framework by which qualitative decisions concerning overall quality could be made, and was useful for detecting potential sources of bias in the available evidence.

Exercise and Auricular Acupuncture for Chronic Low Back Pain: A Feasibility Randomised Controlled Trial

Objectives: To evaluate the feasibility of a randomized-controlled trial (RCT) investigating the effects of adding auricular acupuncture (AA) to exercise for participants with chronic low-back pain (CLBP). Methods: Participants with CLBP were recruited from primary care and a university population and were randomly allocated (n=51) to 1 of 2 groups: (1) "Exercise Alone (E)"-12-week program consisting of 6 weeks of supervised exercise followed by 6 weeks unsupervised exercise (n=27); or (2) "Exercise and AA (EAA)"-12-week exercise program and AA (n=24). Outcome measures were recorded at baseline, week 8, week 13, and 6 months. The primary outcome measure was the Oswestry Disability Questionnaire. Results: Participants in the EAA group demonstrated a greater mean improvement of 10.7% points (95% confidence interval, -15.3,-5.7) (effect size=1.20) in the Oswestry Disability Questionnaire at 6 months compared with 6.7% points (95% confidence interval, -11.4,-1.9) in the E group (effect size=0.58). There was also a trend towards a greater mean improvement in quality of life, LBP intensity and bothersomeness, and fear-avoidance beliefs in the EAA group. The dropout rate for this trial was lower than anticipated (15% at 6 mo), adherence with exercise was similar (72% E; 65% EAA). Adverse effects for AA ranged from 1% to 14% of participants. Discussion: Findings of this study showed that a main RCT is feasible and that 56 participants per group would need to be recruited, using multiple recruitment approaches. AA was safe and demonstrated additional benefits when combined with exercise for people with CLBP, which requires confirmation in a fully powered RCT.

The back 2 activity trial: education and advice versus education and advice plus a structured walking programme for chronic low back pain.:education and advice versus education and advice plus a structured walking programme for chronic low back pain

BACKGROUND: Current evidence supports the use of exercise-based treatment for chronic low back pain that encourages the patient to assume an active role in their recovery. Walking has been shown it to be an acceptable type of exercise with a low risk of injury. However, it is not known whether structured physical activity programmes are any more effective than giving advice to remain active.

METHODS/DESIGN: The proposed study will test the feasibility of using a pedometer-driven walking programme, as an adjunct to a standard education and advice session in participants with chronic low back pain. Fifty adult participants will be recruited via a number of different sources. Baseline outcome measures including self reported function; objective physical activity levels; fear-avoidance beliefs and health-related quality of life will be recorded. Eligible participants will be randomly allocated under strict, double blind conditions to one of two treatments groups. Participants in group A will receive a single education and advice session with a physiotherapist based on the content of the 'Back Book'. Participants in group B will receive the same education and advice session. In addition, they will also receive a graded pedometer-driven walking programme prescribed by the physiotherapist. Follow up outcomes will be recorded by the same researcher, who will remain blinded to group allocation, at eight weeks and six months post randomisation. A qualitative exploration of participants' perception of walking will also be examined by use of focus groups at the end of the intervention. As a feasibility study, treatment effects will be represented by point estimates and confidence intervals. The assessment of participant satisfaction will be tabulated, as will adherence levels and any recorded difficulties or adverse events experienced by the participants or therapists. This information will be used to modify the planned interventions to be used in a larger randomised controlled trial.

DISCUSSION: This paper describes the rationale and design of a study which will test the feasibility of using a structured, pedometer-driven walking programme in participants with chronic low back pain.

TRIAL REGISTRATION: [ISRCTN67030896].

Pedometer-driven walking for chronic low back pain:A feasibility randomized controlled trial

OBJECTIVES: To evaluate the feasibility of an RCT of a pedometer-driven walking program and education/advice to remain active compared with education/advice only for treatment of chronic low back pain (CLBP). METHODS: Fifty-seven participants with CLBP recruited from primary care were randomly allocated to either: (1) education/advice (E, n=17) or (2) education/advice plus an 8-week pedometer-driven walking program (EWP, n=40). Step targets, actual daily step counts, and adverse events were recorded in a walking diary over the 8 weeks of intervention for the EWP group only. All other outcomes (eg, functional disability using the Oswestry Disability Questionnaire (ODQ), pain scores, physical activity (PA) measurement etc.) were recorded at baseline, week 9 (immediately post-intervention), and 6 months in both groups. RESULTS: The recruitment rate was 22% and the dropout rate was lower than anticipated (13% to 18% at 6 mo). Adherence with the EWP was high, 93% (n=37/40) walked for =6 weeks, and increased their steps/day [mean absolute increase in steps/d, 2776, 95% confidence interval (CI), 1996-3557] by 59% (95% CI, 40.73%-76.25%) from baseline. Mean percentage adherence with weekly step targets was 70% (95% CI, 62%-77%). Eight (20%) minor-related adverse events were observed in 13% (5/40) of the participants. The EWP group participants demonstrated an 8.2% point improvement [95% CI, -13 to -3.4] on the ODQ at 6 months compared with 1.6% points [95% CI, -9.3 to 6.1) for the E group (between group d=0.44). There was also a larger mean improvement in pain (d=0.4) and a larger increase in PA (d=0.59) at 6 months in EWP. DISCUSSION: This preliminary study demonstrated that a main RCT is feasible. EWP was safe and produced a real increase in walking; CLBP function and pain improved, and participants perceived a greater improvement in their PA levels. These improvements require confirmation in a fully powered RCT.

Physiotherapy for Sleep Disturbance in People With Chronic Low Back Pain:Results of a Feasibility Randomized Controlled Trial

Objective: To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (=12wks). Design: Randomized controlled trial with evaluations at baseline, 3 months, and 6 months. Setting: Outpatient physiotherapy department in an academic teaching hospital. Participants: Participants with CLBP were randomly assigned to a walking program (n=20; mean age ± SD, 46.4±13.8y), supervised exercise class (n=20; mean age ± SD, 41.3±11.9y), or usual physiotherapy (n=20; mean age ± SD, 47.1±14.3y). The 3-month evaluation was completed by 44 participants (73%), and 42 (70%) participants completed the 6-month evaluation. Interventions: Participants received a physiotherapy-delivered 8-week walking program, an 8-week group supervised exercise class (1 class/wk), or 1-to-1 usual physiotherapy (advice, manual therapy, and exercise). Main Outcome Measures: Sleep was assessed by the self-reported Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Pittsburgh Sleep Diary, and objective actigraphy. Results: Groups were comparable at baseline. Most (95%, n=57) of the participants had sleep disturbance. The acceptability of actigraphy was excellent at baseline (58 of 60 participants), but dropped at 3 months (26 of 44 participants). There were improvements on the PSQI and ISI in all groups at 3 and 6 months, with predominantly medium effect sizes (Cohen d=0.2-0.5). Conclusions: The high prevalence of sleep disturbance indicated the feasibility of good recruitment in future trials. The PSQI would be a suitable screening tool and outcome measure alongside an objective nonobtrusive sleep outcome measure. The effectiveness of physiotherapy for sleep disturbance in CLBP warrants investigation in a fully powered randomized controlled trial. © 2013 American Congress of Rehabilitation Medicine.