Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS).

INTRODUCTION: Chronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches. METHODS AND ANALYSIS: Chronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. ETHICS AND DISSEMINATION: This trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West - Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019. TRIAL REGISTRATION NUMBER: ISRCTN79708100.

Non-pharmacological self-management for people living with migraine or tension-type headache: a systematic review including analysis of intervention components.

OBJECTIVES: To assess the effect of non-pharmacological self-management interventions against usual care, and to explore different components and delivery methods within those interventions PARTICIPANTS: People living with migraine and/or tension-type headache INTERVENTIONS: Non-pharmacological educational or psychological self-management interventions; excluding biofeedback and physical therapy.We assessed the overall effectiveness against usual care on headache frequency, pain intensity, mood, headache-related disability, quality of life and medication consumption in meta-analysis.We also provide preliminary evidence on the effectiveness of intervention components and delivery methods. RESULTS: We found a small overall effect for the superiority of self-management interventions over usual care, with a standardised mean difference (SMD) of -0.36 (-0.45 to -0.26) for pain intensity; -0.32 (-0.42 to -0.22) for headache-related disability, 0.32 (0.20 to 0.45) for quality of life and a moderate effect on mood (SMD=0.53 (-0.66 to -0.40)). We did not find an effect on headache frequency (SMD=-0.07 (-0.22 to 0.08)).Assessment of components and characteristics suggests a larger effect on pain intensity in interventions that included explicit educational components (-0.51 (-0.68 to -0.34) vs -0.28 (-0.40 to -0.16)); mindfulness components (-0.50 (-0.82 to -0.18) vs 0.34 (-0.44 to -0.24)) and in interventions delivered in groups vs one-to-one delivery (0.56 (-0.72 to -0.40) vs -0.39 (-0.52 to -0.27)) and larger effects on mood in interventions including a cognitive-behavioural therapy (CBT) component with an SMD of -0.72 (-0.93 to -0.51) compared with those without CBT -0.41 (-0.58 to -0.24). CONCLUSION: Overall we found that self-management interventions for migraine and tension-type headache are more effective than usual care in reducing pain intensity, mood and headache-related disability, but have no effect on headache frequency. Preliminary findings also suggest that including CBT, mindfulness and educational components in interventions, and delivery in groups may increase effectiveness. TRIAL REGISTRATION NUMBER: PROSPERO 2016:CRD42016041291.

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$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$277], 95% CI -£125 [-US$184] to £501 [US$738]), resulting in an incremental cost-effectiveness ratio of £5,786 (US$8,521) per QALY. Limitations include the fact that the intervention was relatively brief and did not include any physical activity components. CONCLUSIONS: While the COPERS intervention was brief, safe, and inexpensive, with a low attrition rate, it was not effective for reducing pain-related disability over 12 mo (primary outcome). For secondary outcomes, we found sustained benefits on depression and social integration at 6 and 12 mo, but there was no effect on anxiety, pain-related self-efficacy, pain acceptance, pain intensity, or the census global health question at 12 mo. There was some evidence that the intervention may be cost-effective based on a modest difference in QALYs between groups. TRIAL REGISTRATION: ISRCTN Registry 24426731.

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.

Advising people with back pain to take time off work: a survey examining the role of private musculoskeletal practitioners in the UK.

Research has demonstrated that health care practitioners' adherence to guidelines for managing low back pain (LBP) remain suboptimal in recommending work absence, but specific beliefs about their role in maintaining patients at work have not been adequately researched. We examined private musculoskeletal practitioners' (chiropractors, osteopaths, and physiotherapists) beliefs and reported clinical behaviours in reference to patients' work. A cross-sectional postal questionnaire of 900 musculoskeletal practitioners included the Attitudes to Back pain in musculoskeletal practitioners questionnaires, reported frequency of four work-related behaviours, and a new measure of practitioners' work-related beliefs. Data from 337 respondents (37%) were analysed. Eighty percent of respondents reported recommending work absence to patients with LBP sometimes, and 14% recommended a work absence often or always. Seventy percent of practitioners never visit the patient's workplace. Most practitioners report that they prescribe exercises that can be carried out at work. Physiotherapists visited the workplace more frequently and gave less sick leave certification than either of the other groups. They also regarded work as more beneficial and less of a threat to exacerbate patients' LBP. There were small but significant correlations between work-related beliefs and reported behaviours. Our study confirms that, in contrast to current guidelines, many practitioners believe that LBP necessitates work absence. Overall, practitioners perceived their role in returning patients to work as limited, and believed that direct contact with employers was beyond their remit. In the UK, physiotherapists appear to be better placed to liaise with work in terms of both their beliefs and activities.

The effectiveness of a posted information package on the beliefs and behavior of musculoskeletal practitioners: the UK Chiropractors, Osteopaths, and Musculoskeletal Physiotherapists Low Back Pain ManagemENT (COMPLeMENT) randomized trial.

STUDY DESIGN: Randomized controlled trial. OBJECTIVE: To investigate the effect of a printed information package on the low back pain (LBP)-related beliefs and reported behavior of musculoskeletal practitioners (chiropractors, osteopaths, and musculoskeletal physiotherapists) across the United Kingdom. SUMMARY OF BACKGROUND DATA: A substantial proportion of musculoskeletal practitioners in United Kingdom does not follow current LBP guideline recommendations. METHODS: In total, 1758 practitioners were randomly allocated to either of the 2 study arms. One arm was posted a printed information package containing guideline recommendations for the management of LBP (n = 876) and the other received no intervention (n = 882). The primary outcome measure consisted of 3 "quality indicators" (activity, work, and bed-rest) relating to a vignette of a patient with LBP, in which responses were dichotomized into either "guideline-inconsistent" or "guideline-consistent." The secondary outcome was the practitioners' LBP-related beliefs, measured using the Health Care Providers Pain and Impairment Relationship Scale. Outcomes were measured at baseline and at 6 months. RESULTS: Follow-up at 6 months was 89%. The changes in reported behavior on the quality indicators were as follows: activity, odds ratio (OR) 1.29 (95% confidence interval, 1.03-1.61) and number needed to be treated (NNT), 19 (15-28); work, OR 1.35 (1.07-1.70) and NNT 19 (14-29); and bed-rest, OR 1.31 (0.97-1.76) and NNT 47 (33-103). The composite NNT for a change from guideline-inconsistent to guideline-consistent behavior on at least 1 of the 3 quality indicators was 10 (9-14). LBP-related beliefs were significantly improved in those who were sent the information package (P = 0.002), but only to a small degree (mean difference, 0.884 scale points; 95% confidence interval, 0.319-1.448). CONCLUSION: Printed educational material can shift LBP-related beliefs and reported behaviors of musculoskeletal practitioners, toward practice that is more in line with guideline recommendations.

Returning back pain patients to work: how private musculoskeletal practitioners outside the national health service perceive their role (an interview study).

BACKGROUND: Private musculoskeletal practitioners treat a large section of people with back pain, and could play an important role in returning and maintaining patients to work. METHOD: We conducted a qualitative study to explore the self-perceived role of such practitioners in the UK. We interviewed 44 practitioners, including chiropractors, osteopaths and physiotherapists. RESULTS: Thematic analysis of the interview transcripts indicated that return to work is a high priority for patients, many of whom are self-employed. Although in general work was perceived as beneficial to health, practitioners perceived work as a threat for some of their back pain patients. They perceived their role as giving ergonomic, postural and exercise based advice, but were more reluctant to address psychosocial problems related to back pain. A common view was that patients' reluctance to take a break from work impacted badly on their condition, and many practitioners advocated a short time off work duties to focus on rehabilitation. Contact with employers was very limited, and determined by the patients' request. CONCLUSION: In summary, the study identifies several areas in which further education could expand the role of musculoskeletal practitioners and benefit their back pain patients. However, further study is required to determine whether these results are generalisable beyond the limits of this qualitative study UK based study.

Attitudes to back pain amongst musculoskeletal practitioners: a comparison of professional groups and practice settings using the ABS-mp.

Chiropractors, osteopaths and physiotherapists play key roles in the management of low back pain (LBP) patients in the UK. We investigated the attitudes of these three professional groups to back pain using a recently developed and validated questionnaire, the Attitudes to Back Pain Scale for musculoskeletal practitioners (ABS-mp). A cross-sectional questionnaire survey was sent to 300 of each professional group (n=900). Responses were analysed from 465 practitioners: 132 chiropractors (28%), 159 osteopaths (34%) and 174 physiotherapists (37%). Overall, all three groups endorse a psychosocial approach to treatment, and see re-activation as a primary goal. However, physiotherapists and osteopaths tend to endorse attitudes towards limiting the number of treatment sessions offered to LBP patients more than chiropractors, and chiropractors endorse a more biomedical approach than physiotherapists. When practice setting (NHS versus private practice) was considered (in physiotherapists alone), physiotherapists working for the NHS endorsed limiting the number of treatment sessions more than those working in the private sector and would also less frequently advise their patients to restrict activities and be vigilant. The results may help explain current clinical practice patterns observed in these groups and their uptake of clinical guideline recommendations.

The attitudes to back pain scale in musculoskeletal practitioners (ABS-mp): the development and testing of a new questionnaire.

OBJECTIVES: Little is known about practitioners' beliefs and attitudes to the treatment of low back pain, and whether these influence their clinical decisions, intervention strategies, and patient-centered outcomes. This study aimed to develop, test, and explore the underlying dimensions of a new questionnaire, the Attitudes to Back Pain Scale (ABS), in a specific group of clinicians, practitioners who specialize in musculoskeletal therapy. METHODS: Items for the draft questionnaire were derived from interviews with practitioners (chiropractors, osteopaths, and physiotherapists). The draft questionnaire (52 items) sought to assess practitioners' attitudes concerning role and self-image plus their beliefs about treatment goals and prognosis of low back pain. The questionnaire was sent to a random selection of 300 practitioners from each professional group, and 546 (61%) responded. Split-sample analyses were performed using exploratory and confirmatory factor analysis. RESULTS: Separate exploratory analyses were done for attitudes concerned with personal interaction (34 items) and attitudes about treatment orientation (18 items), producing six domains: limitations on sessions, psychologic, connection to health care system, confidence and concern, reactivation, and biomedical. Confirmatory analyses indicated that the model tested presented a good fit. Validity interviews revealed high agreement of categorization and low levels of difficulty in categorizing the items. CONCLUSIONS: The internal structure of the new questionnaire not only shows excellent psychometric properties and good face validity, but also has the added advantage of being developed with a specific clinical context in mind. Additional evaluation is required to fully describe the psychometric integrity of this instrument.

Persistent back pain--why do physical therapy clinicians continue treatment? A mixed methods study of chiropractors, osteopaths and physiotherapists.

AIMS: (a) To investigate how widespread is the use of long term treatment without improvement amongst clinicians treating individuals with low back pain. (b) To study the beliefs behind the reasons why chiropractors, osteopaths and physiotherapists continue to treat people whose low back pain appears not to be improving. METHODS: A mixed methods study, including a questionnaire survey and qualitative analysis of semi-structured interviews. Questionnaire survey; 354/600 (59%) clinicians equally distributed between chiropractic, osteopathy and physiotherapy professions. Interview study; a purposive sample of fourteen clinicians from each profession identified from the survey responses. Methodological techniques ranged from grounded theory analysis to sorting of categories by both the research team and the subjects themselves. RESULTS: At least 10% of each of the professions reported that they continued to treat patients with low back pain who showed almost no improvement for over three months. There is some indication that this is an underestimate. reasons for continuing unsuccessful management of low back pain were not found to be primarily monetary in nature; rather it appears to have much more to do with the scope of care that extends beyond issues addressed in the current physical therapy guidelines. The interview data showed that clinicians viewed their role as including health education and counselling rather than a 'cure or refer' approach. Additionally, participants raised concerns that discharging patients from their care meant sending them to into a therapeutic void. CONCLUSION: Long-term treatment of patients with low back pain without objective signs of improvement is an established practice in a minority of clinicians studied. This approach contrasts with clinical guidelines that encourage self-management, reassurance, re-activation, and involvement of multidisciplinary teams for patients who do not recover. Some of the rationale provided makes a strong case for ongoing contact. However, the practice is also maintained through poor communication with other professions and mistrust of the healthcare system.

Testing the effectiveness of an innovative information package on practitioner reported behaviour and beliefs: the UK Chiropractors, Osteopaths and Musculoskeletal Physiotherapists Low back pain ManagemENT (COMPLeMENT) trial [ISRCTN77245761].

BACKGROUND: Low back pain (LBP) is a common and costly problem. Initiatives designed to assist practitioner and patient decisions about appropriate healthcare for LBP include printed evidence-based clinical guidelines. The three professional groups of chiropractic, osteopathy and musculoskeletal physiotherapy in the UK share common ground with their approaches to managing LBP and are amongst those targeted by LBP guidelines. Even so, many seem unaware that such guidelines exist. Furthermore, the behaviour of at least some of these practitioners differs from that recommended in these guidelines. Few randomised controlled trials evaluating printed information as an intervention to change practitioner behaviour have utilised a no-intervention control. All these trials have used a cluster design and most have methodological flaws. None specifically focus upon practitioner behaviour towards LBP patients. Studies that have investigated other strategies to change practitioner behaviour with LBP patients have produced conflicting results. Although numerous LBP guidelines have been developed worldwide, there is a paucity of data on whether their dissemination actually changes practitioner behaviour. Primarily because of its low unit cost, sending printed information to large numbers of practitioners is an attractive dissemination and implementation strategy. The effect size of such a strategy, at an individual practitioner level, is likely to be small. However, if large numbers of practitioners are targeted, this strategy might achieve meaningful changes at a population level. METHODS: The primary aim of this prospective, pragmatic randomised controlled trial is to test the short-term effectiveness (six-months following intervention) of a directly-posted information package on the reported clinical behaviour (primary outcome), attitudes and beliefs of UK chiropractors, osteopaths and musculoskeletal physiotherapists. We sought to randomly allocate a combined sample of 1,800 consenting practitioners to receive either the information package (intervention arm) or no information above that gained during normal practice (control arm). We collected questionnaire data at baseline and six-months post-intervention. The analysis of the primary outcome will assess between-arm differences of proportions of responses to questions on recommendations about activity, work and bed-rest, that fall within categories previously defined by an expert consensus exercise as either 'guideline-consistent' and 'guideline-inconsistent'.

Cognitive bias in back pain patients attending osteopathy: testing the enmeshment model in reference to future thinking.

BACKGROUND: Depressive symptoms are common in chronic pain. Previous research has found differences in information-processing biases in depressed pain patients and depressed people without pain. The schema enmeshment model of pain (SEMP) has been proposed to explain chronic pain patients' information-processing biases. Negative future thinking is common in depression but has not been explored in relation to chronic pain and information-processing models. OBJECTIVES: The study aimed to test the SEMP with reference to future thinking. METHODS: An information-processing paradigm compared endorsement and recall bias between depressed and non-depressed chronic low back pain patients and control participants. Twenty-five depressed and 35 non-depressed chronic low back pain patients and 25 control participants (student osteopaths) were recruited from an osteopathy practice. Participants were asked to endorse positive and negative ill-health, depression-related, and neutral (control) adjectives, encoded in reference to either current or future time-frame. Incidental recall of the adjectives was then tested. RESULTS: While the expected hypothesis of a recall bias by depressed pain patients towards ill-health stimuli in the current condition was confirmed, the recall bias was not present in the future condition. Additionally, patterns of endorsement and recall bias differed. DISCUSSION: Results extend understanding of future thinking in chronic pain within the context of the SEMP.

Treatment and the process of care in musculoskeletal conditions. A multidisciplinary perspective and integration.

Chronic musculoskeletal pain for which there is not an obvious underlying physical cause is one of the most common reasons for long-term disability. There is a need to develop better ways of managing these problems. Improving the understanding of the basis for decision making, the processes of care, and the beliefs and expectations of patients and health care professionals seems as fundamental as basic laboratory science is to understanding inflammatory arthopathies. Little is known about the beliefs and expectations of patients and health care professionals, nor the multitude of factors such as traditions within professional groups, education, and language that professionals use in decision making. When better understanding of these factors and the mismatch between professionals and patients is achieved, then theoretical frameworks, treatment approaches, and the education of professionals in appropriate management will be improved.