Dawn Carnes

Adverse events and manual therapy: A systematic review

OBJECTIVE To explore the incidence and risk of adverse events with manual therapies. METHOD The main health electronic databases, plus those specific to allied medicine and manual therapy, were searched. Our inclusion criteria were: manual therapies only; administered by regulated therapists; a clearly described intervention; adverse events reported. We performed a meta-analysis using incident estimates of proportions and random effects models. RESULTS Eight prospective cohort studies and 31 manual therapy RCTs were accepted. The incidence estimate of proportions for minor or moderate transient adverse events after manual therapy was approximately 41% (CI 95% 17-68%) in the cohort studies and 22% (CI 95% 11.1-36.2%) in the RCTs; for major adverse events approximately 0.13%. The pooled relative risk (RR) for experiencing adverse events with exercise, or with sham/passive/control interventions compared to manual therapy was similar, but for drug therapies greater (RR 0.05, CI 95% 0.01-0.20) and less with usual care (RR 1.91, CI 95% 1.39-2.64). CONCLUSIONS The risk of major adverse events with manual therapy is low, but around half manual therapy patients may experience minor to moderate adverse events after treatment. The relative risk of adverse events appears greater with drug therapy but less with usual care.

Effective delivery styles and content for self-management interventions for chronic musculoskeletal pain: a systematic literature review

Objectives:The objective of the study was to report the evidence for effectiveness of different self-management course characteristics and components for chronic musculoskeletal pain. Methods:We searched 9 relevant electronic databases for randomized, controlled trials (RCTs). Two reviewers selected studies against inclusion criteria and assessed their quality. We classified RCTs according to type of course delivery (group, individual, mixed or remote), tutor (healthcare professional, lay or mixed), setting (medical, community or occupational), duration (more or less than 8 weeks), and the number and type of components (psychological, lifestyle, pain education, mind body therapies, and physical activity). We extracted data on pain intensity, physical function, self-efficacy, global health, and depression and compared these outcomes for self-management and usual care or waiting list control. We used random effects standardized mean difference meta-analysis. We looked for patterns of clinically important and statistically significant beneficial effects for courses with different delivery characteristics and the presence or absence of components across outcomes over 3 follow-up intervals. Results:We included 46 RCTs (N=8539). Group-delivered courses that had healthcare professional input showed more beneficial effects. Longer courses did not necessarily give better outcomes. There was mixed evidence of effectiveness for components of courses, but data for courses with a psychological component showed slightly more consistent beneficial effects over each follow-up period. Discussion:Serious consideration should be given to the development of short (<8 weeks) group and healthcare professional-delivered interventions but more research is required to establish the most effective and cost-effective course components.

Can we identify how programmes aimed at promoting self-management in musculoskeletal pain work and who benefits? A systematic review of sub-group analysis within RCTs

Background: There are now several systematic reviews of RCTs testing self‐management for those with chronic musculoskeletal pain. Evidence for the effectiveness of self‐management interventions in chronic musculoskeletal pain is equivocal and it is not clear for which sub‐groups of patients SM is optimally effective.

Measuring pain self-efficacy

BackgroundIt is likely that people with chronic pain who have low self-efficacy have a worse prognosis. A standard, high-quality measure of self-efficacy in such populations would improve evidence, by allowing meaningful comparisons amongst subgroups and between treatments, and by facilitating pooling across studies in systematic reviews. ObjectivesTo identify self-administered pain-related self-efficacy measures used in people with chronic pain and to evaluate the clinimetric evidence of the most commonly used scales systematically. MethodsWe searched 2 databases to identify self-efficacy questionnaires. We evaluated questionnaires identified against previously developed criteria for clinimetric assessment. ResultsWe identified 13 relevant measurements assessing self-efficacy, and clinimetrically assessed 5 of these. These questionnaires were the Arthritis Self-Efficacy Scale, the Chronic Disease Self-Efficacy Scale, the Pain Self-Efficacy Questionnaire, the Chronic Pain Self-Efficacy Scale, and the Self-Efficacy Scale. None of the questionnaires showed satisfactory results for all properties. All scales were easily scored and dimensionality was assessed in 2 of 6 of the scales. Internal consistency was acceptable for all questionnaires. There was positive evidence for construct validity in 4 of 6 of the questionnaires. None of the studies used the most up-to-date method of test-retest reliability or responsiveness. Information on interpretability of the scores was minimal in all questionnaires. DiscussionFurther research should focus on assessing responsiveness and interpretability of these questionnaires. Researchers should select questionnaires that are most appropriate for their study aims and population and contribute to further validation of these scales. Future research should measure outcome expectancy alongside self-efficacy to best predict future behavior.

A systematic review of pain drawing literature: should pain drawings be used for psychologic screening?

ObjectivesThe use of pain drawings to identify the psychologic “state” of patients has been advocated. They are used for psychologic screening before considering treatments, such as surgery. For pain drawings to be clinically useful as a psychologic screen they need good positive and negative predictive values. We systematically reviewed the literature that directly compared pain drawing scoring systems with measures of psychologic state. MethodWe searched 12 medical and social science databases, using key words and their derivatives. Nineteen articles were suitable for analysis. The majority focused on low back pain (79%) in secondary or tertiary care (90%). Pain drawings were evaluated against psychologic tools testing: somatization, depression, anxiety, and distress. ResultsThree studies concluded that the association between pain drawings and psychologic state was sufficient for clinical use; of these only 1 showed reasonable sensitivity and specificity data. Six reported a statistical association and 10/19 studies reported inconclusive results and weak association. The pooled median sensitivity score was 56% (range 24% to 93%), specificity 79.5% (range 44% to 91%), positive predictive value 71.5% (range 28% to 94%), and negative predictive value 88% (range 35% to 100%). The predictive data were too low, wide-ranging, and inconsistent to accept the pain drawing as a clinical diagnostic tool to predict psychologic state. ConclusionsWe conclude that the available data do not support the assumption that unusual pain drawings or extensive marking indicate disturbed psychologic state. There is no high quality evidence to support pain-drawing use as a psychologic assessment tool; therefore, pain drawings are not recommended for this purpose.

Influences on older people’s decision making regarding choice of topical or oral NSAIDs for knee pain: qualitative study

Objective To explore the factors that influence older people’s decision making regarding use of topical or oral ibuprofen for their knee pain. Design Qualitative interview study nested within a randomised controlled trial and a patient preference study that compared advice to use oral or topical non-steroidal anti-inflammatory drugs (NSAIDs) for knee pain in older people. Setting 11 general practices. Participants 30 people aged ≥50 with knee pain. Results Participants’ decision making was influenced by their perceptions of the associated risk of adverse effects, presence of other illness, nature of their pain, advice received, and practicality. Although participants’ understanding of how the medications worked was sometimes poor their decision making about the use of NSAIDs seemed logical and appropriate. Participants’ model for treatment was to use topical NSAIDs for mild, local, and transient pain and oral NSAIDs for moderate to severe, generalised, and constant pain (in the absence of other more serious illness or risk of adverse effects). Participants showed marked tolerance and normalisation of adverse effects. Conclusion Participants had clear ideas about the appropriate use of oral and topical NSAIDs. Taking such views into account when prescribing may improve adherence, judgment of efficacy, and the doctor-patient relationship. Tolerance and normalisation of adverse effects in these patients indicate that closer monitoring of older people who use NSAIDs might be needed.

Evidence for non-communicable diseases: analysis of Cochrane reviews and randomised trials by World Bank classification

Introduction Prevalence of non-communicable diseases (NCDs) is increasing globally, with the greatest projected increases in low-income and middle-income countries. We sought to quantify the proportion of Cochrane evidence relating to NCDs derived from such countries. Methods We searched the Cochrane database of systematic reviews for reviews relating to NCDs highlighted in the WHO NCD action plan (cardiovascular, cancers, diabetes and chronic respiratory diseases). We excluded reviews at the protocol stage and those that were repeated or had been withdrawn. For each review, two independent researchers extracted data relating to the country of the corresponding author and the number of trials and participants from countries, using the World Bank classification of gross national income per capita. Results 797 reviews were analysed, with a reported total number of 12 340 trials and 10 937 306 participants. Of the corresponding authors 90% were from high-income countries (41% from the UK). Of the 746 reviews in which at least one trial had met the inclusion criteria, only 55% provided a summary of the country of included trials. Analysis of the 633 reviews in which country of trials could be established revealed that almost 90% of trials and over 80% of participants were from high-income countries. 438 (5%) trials including 1 145 013 (11.7%) participants were undertaken in low-middle income countries. We found that only 13 (0.15%) trials with 982 (0.01%) participants were undertaken in low-income countries. Other than the five Cochrane NCD corresponding authors from South Africa, only one other corresponding author was from Africa (Gambia). Discussion The overwhelming body of evidence for NCDs pertains to high-income countries, with only a small number of review authors based in low-income settings. As a consequence, there is an urgent need for research infrastructure and funding for the undertaking of high-quality trials in this area.

Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS)

Introduction Chronic musculoskeletal pain is a common condition that often responds poorly to treatment. Self-management courses have been advocated as a non-drug pain management technique, although evidence for their effectiveness is equivocal. We designed and piloted a self-management course based on evidence for effectiveness for specific course components and characteristics. Methods/analysis COPERS (coping with persistent pain, effectiveness research into self-management) is a pragmatic randomised controlled trial testing the effectiveness and cost-effectiveness of an intensive, group, cognitive behavioural-based, theoretically informed and manualised self-management course for chronic pain patients against a control of best usual care: a pain education booklet and a relaxation CD. The course lasts for 15 h, spread over 3 days, with a –2 h follow-up session 2 weeks later. We aim to recruit 685 participants with chronic musculoskeletal pain from primary, intermediate and secondary care services in two UK regions. The study is powered to show a standardised mean difference of 0.3 in the primary outcome, pain-related disability. Secondary outcomes include generic health-related quality of life, healthcare utilisation, pain self-efficacy, coping, depression, anxiety and social engagement. Outcomes are measured at 6 and 12 months postrandomisation. Pain self-efficacy is measured at 3 months to assess whether change mediates clinical effect. Ethics/dissemination Ethics approval was given by Cambridgeshire Ethics 11/EE/046. This trial will provide robust data on the effectiveness and cost-effectiveness of an evidence-based, group self-management programme for chronic musculoskeletal pain. The published outcomes will help to inform future policy and practice around such self-management courses, both nationally and internationally. Trial registration ISRCTN24426731.

Novel three-day, community-based, nonpharmacological group intervention for chronic musculoskeletal pain (COPERS): a randomised clinical trial

Background Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain. Methods and Findings We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost–utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle, accounted for clustering by course in the intervention arm, and used multiple imputation for missing or incomplete primary outcome data. The mean age of participants was 59.9 y, with 81% white, 67% female, 23% employed, 85% with pain for at least 3 y, and 23% on strong opioids. Symptoms of depression and anxiety were common (baseline mean HADS scores 7.4 [standard deviation 4.1] and 9.2 [4.6], respectively). Overall, 282 (70%) intervention participants met the predefined intervention adherence criterion. Primary outcome data were obtained from 88% of participants. There was no significant difference between groups in pain-related disability at 6 or 12 mo (12 mo: difference −1.0, intervention versus control, 95% CI −4.9 to 3.0), pain intensity, or the census global health question. Anxiety, depression, pain-related self-efficacy, pain acceptance, and social integration were better in the intervention group at 6 mo; at 12 mo, these differences remained statistically significant only for depression (−0.7, 95% CI −1.2 to −0.2) and social integration (0.8, 95% CI 0.4 to 1.2). Intervention participants received more analgesics than the controls across the 12 mo. The total cost of the course per person was £145 (US

Mapping care pathways and estimating the number and cost of musculoskeletal chronic pain patients to inform the development and implementation of a new service

214). The cost–utility analysis showed there to be a small benefit in terms of quality-adjusted life years (QALYs) (0.0325, 95% CI −0.0074 to 0.0724), and on the cost side the intervention was a little more expensive than usual care (i.e., £188 [US