Slow and Steady But Not Related to HIV Stigma: Physical Activity in South Africans Living with HIV and Chronic Pain.

HIV stigma may influence physical activity in people living with HIV (PLWH) and chronic pain. We prospectively examined the relationship between stigma, activity and chronic pain in a convenience sample of PLWH initiating antiretroviral therapy in an inner-city clinic in Johannesburg, South Africa. Participants wore accelerometers to measure daily duration and intensity of activity for 2 weeks. Stigma was assessed with the Revised HIV Stigma Scale. Participants [n = 81, 89% female, age mean (SD) 42 (8)] were active for a median of 7 h daily (IQR 5.2, 9.2), but at very low intensity, equivalent to a slow walk [median (IQR): 0.39 m s-1 (0.33, 0.50)]. Duration and intensity of activity was not associated with stigma, even after controlling for age, self-assessed wealth, pain intensity and willingness to engage in physical activity (p-values > 0.05). As stigma did not associate with greater activity, drivers of sustained activity in South African PLWH remain unclear.

RESUMEN: El estigma del VIH puede influir en la actividad física de las personas que viven con el VIH (PVVS) y el dolor crónico. Se examinó prospectivamente la relación entre el estigma, la actividad y el dolor crónico en una muestra de conveniencia de PVVS que iniciaba la terapia antirretroviral en una clínica del centro de la ciudad en Johannesburgo, Sudáfrica. Los participantes usaron acelerómetros para medir la duración diaria y la intensidad de la actividad durante dos semanas. El estigma se evaluó con la escala revisada de estigma del VIH. Los participantes [n = 81, 89% mujeres, media de edad (SD) 42 (8)] tenían una actividad de intensidad muy baja, para una mediana de siete horas diarias (IQR 5.2, 9.2), pero, equivalente a una marcha lenta [mediana (IQR): 0.39 m s−1 (0.33, 0.50)]. La duración y la intensidad de la actividad no se asociaron con los niveles de estigma, incluso después de controlar la edad, la riqueza autoevaluada, la intensidad del dolor y la voluntad de participar en la actividad física (valores de p > 0.05). Como el estigma no se asoció con una mayor actividad, los impulsores de la actividad sostenida en las PVVS sudafricanas siguen sin estar claros.

Antidepressants for pain management in adults with chronic pain: a network meta-analysis.

BACKGROUND: Chronic pain is common in adults, and often has a detrimental impact upon physical ability, well-being, and quality of life. Previous reviews have shown that certain antidepressants may be effective in reducing pain with some benefit in improving patients' global impression of change for certain chronic pain conditions. However, there has not been a network meta-analysis (NMA) examining all antidepressants across all chronic pain conditions. OBJECTIVES: To assess the comparative efficacy and safety of antidepressants for adults with chronic pain (except headache). SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, AMED and PsycINFO databases, and clinical trials registries, for randomised controlled trials (RCTs) of antidepressants for chronic pain conditions in January 2022. SELECTION CRITERIA: We included RCTs that examined antidepressants for chronic pain against any comparator. If the comparator was placebo, another medication, another antidepressant, or the same antidepressant at different doses, then we required the study to be double-blind. We included RCTs with active comparators that were unable to be double-blinded (e.g. psychotherapy) but rated them as high risk of bias. We excluded RCTs where the follow-up was less than two weeks and those with fewer than 10 participants in each arm.  DATA COLLECTION AND ANALYSIS: Two review authors separately screened, data extracted, and judged risk of bias. We synthesised the data using Bayesian NMA and pairwise meta-analyses for each outcome and ranked the antidepressants in terms of their effectiveness using the surface under the cumulative ranking curve (SUCRA). We primarily used Confidence in Meta-Analysis (CINeMA) and Risk of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN) to assess the certainty of the evidence. Where it was not possible to use CINeMA and ROB-MEN due to the complexity of the networks, we used GRADE to assess the certainty of the evidence. Our primary outcomes were substantial (50%) pain relief, pain intensity, mood, and adverse events. Our secondary outcomes were moderate pain relief (30%), physical function, sleep, quality of life, Patient Global Impression of Change (PGIC), serious adverse events, and withdrawal. MAIN RESULTS: This review and NMA included 176 studies with a total of 28,664 participants. The majority of studies were placebo-controlled (83), and parallel-armed (141). The most common pain conditions examined were fibromyalgia (59 studies); neuropathic pain (49 studies) and musculoskeletal pain (40 studies). The average length of RCTs was 10 weeks. Seven studies provided no useable data and were omitted from the NMA. The majority of studies measured short-term outcomes only and excluded people with low mood and other mental health conditions. Across efficacy outcomes, duloxetine was consistently the highest-ranked antidepressant with moderate- to high-certainty evidence. In duloxetine studies, standard dose was equally efficacious as high dose for the majority of outcomes. Milnacipran was often ranked as the next most efficacious antidepressant, although the certainty of evidence was lower than that of duloxetine. There was insufficient evidence to draw robust conclusions for the efficacy and safety of any other antidepressant for chronic pain.  Primary efficacy outcomes Duloxetine standard dose (60 mg) showed a small to moderate effect for substantial pain relief (odds ratio (OR) 1.91, 95% confidence interval (CI) 1.69 to 2.17; 16 studies, 4490 participants; moderate-certainty evidence) and continuous pain intensity (standardised mean difference (SMD) -0.31, 95% CI -0.39 to -0.24; 18 studies, 4959 participants; moderate-certainty evidence). For pain intensity, milnacipran standard dose (100 mg) also showed a small effect (SMD -0.22, 95% CI -0.39 to 0.06; 4 studies, 1866 participants; moderate-certainty evidence). Mirtazapine (30 mg) had a moderate effect on mood (SMD -0.5, 95% CI -0.78 to -0.22; 1 study, 406 participants; low-certainty evidence), while duloxetine showed a small effect (SMD -0.16, 95% CI -0.22 to -0.1; 26 studies, 7952 participants; moderate-certainty evidence); however it is important to note that most studies excluded participants with mental health conditions, and so average anxiety and depression scores tended to be in the 'normal' or 'subclinical' ranges at baseline already. Secondary efficacy outcomes Across all secondary efficacy outcomes (moderate pain relief, physical function, sleep, quality of life, and PGIC), duloxetine and milnacipran were the highest-ranked antidepressants with moderate-certainty evidence, although effects were small. For both duloxetine and milnacipran, standard doses were as efficacious as high doses. Safety There was very low-certainty evidence for all safety outcomes (adverse events, serious adverse events, and withdrawal) across all antidepressants. We cannot draw any reliable conclusions from the NMAs for these outcomes. AUTHORS' CONCLUSIONS: Our review and NMAs show that despite studies investigating 25 different antidepressants, the only antidepressant we are certain about for the treatment of chronic pain is duloxetine. Duloxetine was moderately efficacious across all outcomes at standard dose. There is also promising evidence for milnacipran, although further high-quality research is needed to be confident in these conclusions. Evidence for all other antidepressants was low certainty. As RCTs excluded people with low mood, we were unable to establish the effects of antidepressants for people with chronic pain and depression. There is currently no reliable evidence for the long-term efficacy of any antidepressant, and no reliable evidence for the safety of antidepressants for chronic pain at any time point.

Implementation of the Enhanced Transtheoretical Model Intervention (ETMI) for Low Back Pain Patients in Primary Care: Study Protocol.

BACKGROUND: Self-management, an active life routine, and adherence to physical activity are effective in the management of low back pain (LBP). However, delivering effective education and reassurance to patients can be a difficult for practitioners. The enhanced transtheoretical model intervention (ETMI) has shown to be successful and cost effective. The intervention focuses on educating practitioners to reassure patients, empower them to increase physical activity, and improve their self-efficacy. OBJECTIVES: To assess whether ETMI can be implemented among primary care practitioners and to examine whether it reduces pain, disability, and fear avoidance as well as decreasing healthcare utilization. This protocol outlines the methodology for the implementation of ETMI through a hybrid implementation-effectiveness design. METHODS: Two qualitative and mixed-method studies provided a basis for an implementation prospective cohort study. Discussions are followed by a prospective cohort study with pre-and post-intervention measures as well as descriptions retrieving economic and therapeutic outcome data from the Maccabi Healthcare Services (MHS) databases. In addition, a fourth qualitative study was conducted at the midpoint of the implementation to evaluate the process by measuring the perceptions and practice of practitioners. The intervention group was 220 primary care practitioners and their patients (~n=10,000) from the central district of MHS. The control data was provided by other care districts with similar socioeconomic makeup (~n=40,000). CONCLUSIONS: We evaluated the process and outcomes of the implementation of ETMI. We investigated the relationship between the care received (ETMI against treatment as usual) and healthcare utilization, costs, and patient-clinical outcomes.

Improving consultations for persistent musculoskeletal low back pain in orthopaedic spine settings: an intervention development.

BACKGROUND: There is a need to improve consultations between patients with persistent musculoskeletal low back pain and orthopaedic spine clinicians when surgery is not indicated. Poor communication and lack of education about self- management in these consultations have been shown to be associated with increased distress and higher subsequent health care seeking. AIM: To develop a standardised intervention to improve spine care consultations for patients for whom surgery is not beneficial. METHOD: The intervention was developed in six stages. The first three stages included: interviews with patients, an interactive workshop with clinicians from a mix of disciplines, and interviews with spine clinicians about their perspective of the recommendations, their perceived difficulties and potential improvements. Information from these stages was synthesised by an expert panel, creating a draft intervention structure and content. The main features of the intervention and the materials developed were then reviewed by patients and spine clinicians. Finally, the research team incorporated the recommended amendments to produce the intervention. RESULTS: In total, 36 patients and 79 clinicians contributed to the development of the intervention. The final intervention includes three components: a pre-consultation letter with information suggesting that surgery is one possible intervention amongst many, introducing the staff, and alerting patients to bring with them a potted history of interventions tried previously. The intervention includes short online training sessions to improve clinicians' communication skills, during the consultation, in reference to listening skills, validation of patients' pain, and use of appropriate language. Clinicians are also supplied with a list of evidence-based sources for advice and further information to share with patients. Finally, post consultation, a follow up letter includes a short summary of the patients' clinical journey, the results of their examination and tests, and a reminder of recommendations for self-management. CONCLUSION: The intervention includes aspects around patient education and enhanced clinician skills. It was developed with input from a multitude of stakeholders and is based on patients' perceptions of what they would find reassuring and empowering when surgery is excluded. The intervention has the potential to improve the patients care journey and might lead to changes in practice in spine clinicians.

Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting. METHODS: This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions. DISCUSSION: The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH. TRIAL REGISTRATION: ISRCTN no. 10608766, prospectively registered on 18th March 2019.

Diagnostic and classification tools for chronic headache disorders: A systematic review.

BACKGROUND OR AIM: Despite guidelines and the International Classification of Headache Disorders (ICHD-III beta) criteria, the diagnosis of common chronic headache disorders can be challenging for non-expert clinicians. The aim of the review was to identify headache classification tools that could be used by a non-expert clinician to classify common chronic disorders in primary care. METHODS: We conducted a systematic literature review of studies validating diagnostic and classification headache tools published between Jan 1988 and June 2016 from key databases: MEDLINE, ASSIA, Embase, Web of Knowledge and PsycINFO. Quality assessment was assessed using items of the Quality of Diagnostic Accuracy Studies (QUADAS-2). RESULTS: The search identified 38 papers reporting the validation of 30 tools designed to diagnose, classify or screen for headache disorders; nine for multiple headache types, and 21 for one headache type only. We did not identify a tool validated in a primary care that can be used by a non-expert clinician to classify common chronic headache disorders and screen for primary headaches other than migraine and tension-type headache in primary care. CONCLUSIONS: Despite the availability of many headache classification tools we propose the need for a tool that could support primary care clinicians in diagnosing and managing chronic headache disorders within primary care, and allow more targeted referral to headache specialists.

Individual recovery expectations and prognosis of outcomes in non-specific low back pain: prognostic factor review.

BACKGROUND: Low back pain is costly and disabling. Prognostic factor evidence can help healthcare providers and patients understand likely prognosis, inform the development of prediction models to identify subgroups, and may inform new treatment strategies. Recent studies have suggested that people who have poor expectations for recovery experience more back pain disability, but study results have differed. OBJECTIVES: To synthesise evidence on the association between recovery expectations and disability outcomes in adults with low back pain, and explore sources of heterogeneity. SEARCH METHODS: The search strategy included broad and focused electronic searches of MEDLINE, Embase, CINAHL, and PsycINFO to 12 March 2019, reference list searches of relevant reviews and included studies, and citation searches of relevant expectation measurement tools. SELECTION CRITERIA: We included low back pain prognosis studies from any setting assessing general, self-efficacy, and treatment expectations (measured dichotomously and continuously on a 0 - 10 scale), and their association with work participation, clinically important recovery, functional limitations, or pain intensity outcomes at short (3 months), medium (6 months), long (12 months), and very long (> 16 months) follow-up. DATA COLLECTION AND ANALYSIS: We extracted study characteristics and all reported estimates of unadjusted and adjusted associations between expectations and related outcomes. Two review authors independently assessed risks of bias using the Quality in Prognosis Studies (QUIPS) tool. We conducted narrative syntheses and meta-analyses when appropriate unadjusted or adjusted estimates were available. Two review authors independently graded and reported the overall quality of evidence. MAIN RESULTS: We screened 4635 unique citations to include 60 studies (30,530 participants). Thirty-five studies were conducted in Europe, 21 in North America, and four in Australia. Study populations were mostly chronic (37%), from healthcare (62%) or occupational settings (26%). General expectation was the most common type of recovery expectation measured (70%); 16 studies measured more than one type of expectation. Usable data for syntheses were available for 52 studies (87% of studies; 28,885 participants). We found moderate-quality evidence that positive recovery expectations are strongly associated with better work participation (narrative synthesis: 21 studies; meta-analysis: 12 studies, 4777 participants: odds ratio (OR) 2.43, 95% confidence interval (CI) 1.64 to 3.62), and low-quality evidence for clinically important recovery outcomes (narrative synthesis: 12 studies; meta-analysis: 5 studies, 1820 participants: OR 1.89, 95% CI 1.49 to 2.41), both at follow-up times closest to 12 months, using adjusted data. The association of recovery expectations with other outcomes of interest, including functional limitations (narrative synthesis: 10 studies; meta-analysis: 3 studies, 1435 participants: OR 1.40, 95% CI 0.85 to 2.31) and pain intensity (narrative synthesis: 9 studies; meta-analysis: 3 studies, 1555 participants: OR 1.15, 95% CI 1.08 to 1.23) outcomes at follow-up times closest to 12 months using adjusted data, is less certain, achieving very low- and low-quality evidence, respectively. No studies reported statistically significant or clinically important negative associations between recovery expectations and any low back pain outcome. AUTHORS' CONCLUSIONS: We found that individual recovery expectations are probably strongly associated with future work participation (moderate-quality evidence) and may be associated with clinically important recovery outcomes (low-quality evidence). The association of recovery expectations with other outcomes of interest is less certain. Our findings suggest that recovery expectations should be considered in future studies, to improve prognosis and management of low back pain.

The association between headache and low back pain: a systematic review.

BACKGROUND: To systematically review studies quantifying the association between primary chronic headaches and persistent low back pain (LBP). MAIN TEXT: We searched five electronic databases. We included case-control, cross-sectional and cohort studies that included a headache and back pain free group, reporting on any association between persistent LBP and primary headache disorders. Methodological quality was assessed using Newcastle-Ottawa Scale. Our primary outcome was the association between primary headache disorders and persistent LBP. Our secondary outcomes were any associations between severity of LBP and severity of headache, and the relationship between specific headache sub-types classified as per International Classification of Headache Disorders (ICHD) criteria and persistent LBP. We included 14 studies. The sizes of the studies ranged from 88 participants to a large international study with 404, 206 participants. Odds ratios for the association were between 1.55 (95% confidence interval (CI) 1.13-2.11) and 8.00 (95% CI 5.3-12.1). Study heterogeneity meant statistical pooling was not possible. Only two studies presented data investigating persistent LBP and chronic headache disorders in accordance with ICDH criteria. CONCLUSIONS: We identified a positive association between persistent LBP and primary headache disorders. The quality of the review findings is limited by diversity of populations, study designs and uncertainly about headache and LBP definitions. TRIAL REGISTRATION: PROSPERO 2018 CRD42018086557 .

Development of an education and self-management intervention for chronic headache - CHESS trial (Chronic Headache Education and Self-management Study).

BACKGROUND: Self-management interventions are well recognised and widely used in chronic conditions. Their application to chronic headaches has been limited and generally of low quality. We describe here our process for developing an evidence based, and theory driven, education and self-management intervention for those living with chronic headache. METHODS: Our intervention was designed using several core information sources; the results of three systematic reviews, qualitative material from those living with chronic headaches, our knowledge from existing self-management interventions; and finally collaborative input from a multidisciplinary team of clinicians, academics, patients, and charity partners. We manualised the intervention and associated training as a package for use in a feasibility study. We made adaptations for its use in a randomised controlled trial. RESULTS: We piloted the intervention in four groups with a total of 18 participants. Qualitative feedback from 12 participants and five facilitators allowed the intervention to be refined for the main randomised controlled trial. Some of the key changes included shortening of the overall intervention, changes to the originally planned facilitators and spreading the facilitator training over three days rather than two. We are now testing the final revised intervention in a randomised controlled trial of its clinical and cost effectiveness. The group component of the intervention is delivered over two days with the first day focused on living, understanding and dealing with chronic headaches and the second day exploring how to adapt and take control of one's life with chronic headaches. CONCLUSION: Our pilot work indicates that our intervention is feasible to deliver, and with the relevant changes would be acceptable for use with this population. Our randomised control trial is ongoing. We anticipate publishing final results in 2021. TRIAL REGISTRATION: ISRCTN79708100. Registered 16th December 2015, http://www.isrctn.com/ISRCTN79708100.

The relationship between pain, disability, guilt and acceptance in low back pain: a mediation analysis.

Pain-related guilt is a common yet unexplored psychological factor in low back pain (LBP). It has recently been linked to greater depression, anxiety and disability in LBP, hence an understanding of how it can be managed in the presence of pain and disability is necessary. Since acceptance of pain has been shown to be associated with improved outcomes in chronic pain, we examined whether it might also help reduce guilt in people with LBP. To this end, a series of mediation analyses were conducted on data from 287 patients with chronic LBP, in which acceptance of pain was tested as a mediator of the relationship between pain/disability and guilt. Results showed that acceptance of pain reduced the impact of pain/disability on pain-related guilt in all mediation analyses. Pain-related guilt might be a potential target for acceptance based interventions, thus this relationship should be further tested using longitudinal designs.

The relationship between beliefs about emotions and quality of life in irritable bowel syndrome.

Suppression of undesirable emotions, as well as beliefs about the unacceptability of experiencing and expressing emotions, have both been shown to be related to poorer health-related outcomes in several clinical groups. Potential models through which these variables relate have yet to be tested in those with irritable bowel syndrome (IBS) and are therefore examined in the current article. Online questionnaires were administered to people with IBS (n = 84) to test a mediation model in which beliefs about the unacceptability of emotions are associated with greater emotional suppression, which in turn relates to increased affective distress and consequently poorer quality of life. An alternate model to test the direction of effect along with two further models using support-seeking as mediators of the same predictor and outcome were also tested. Emotional suppression and affective distress (in that particular order) mediate the relationship between beliefs about emotions and quality of life IBS. The models using support-seeking as mediators of the relationship between beliefs about emotions and the two outcomes were not supported. These findings suggest a role for emotional processing in medically unexplained symptoms and imply the need to address such beliefs about emotions in psychological therapies.

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.

Developing and testing a measure of consultation-based reassurance for people with low back pain in primary care: a cross-sectional study.

BACKGROUND: Reassurance from physicians is commonly recommended in guidelines for the management of low back pain (LBP), but the process of reassurance and its impact on patients is poorly researched. We aimed to develop a valid and reliable measure of the process of reassurance during LBP consultations. METHODS: Items representing the data-gathering stage of the consultation and affective and cognitive reassurance were generated from literature on physician-patient communication and piloted with expert researchers and physicians, a Patient and Public Involvement group, and LBP patients to form a questionnaire. Patients presenting for LBP at 43 General Practice surgeries were sent the questionnaire. The questionnaire was analysed with Rasch modelling, using two samples from the same population of recent LBP consultations: the first (n = 157, follow-up n = 84) for exploratory analysis and the second (n = 162, follow-up n = 74) for confirmatory testing. Responses to the questionnaire were compared with responses to satisfaction and enablement scales to assess the external validity of the items, and participants completed the questionnaire again one-week later to assess test-retest reliability. RESULTS: The questionnaire was separated into four subscales: data-gathering, relationship-building, generic reassurance, and cognitive reassurance, each containing three items. All subscales showed good validity within the Rasch models, and good reliability based on person- and item-separations and test-retest reliability. All four subscales were significantly positively correlated with satisfaction and enablement for both samples. The final version of the questionnaire is presented here. CONCLUSIONS: Overall, the measure has demonstrated a good level of validity and generally acceptable reliability. This is the first measure to focus specifically on reassurance for LBP in primary care settings, and will enable researchers to further understanding of what is reassuring within the context of low back pain consultations, and how outcomes are affected by different types of reassurance. Additionally, the measure may provide a useful training and audit tool for physicians. The new measure requires testing in prospective cohorts, and would benefit from further validation against ethnographic observation of consultations in real time.

Delivering an Optimised Behavioural Intervention (OBI) to people with low back pain with high psychological risk; results and lessons learnt from a feasibility randomised controlled trial of Contextual Cognitive Behavioural Therapy (CCBT) vs. Physiotherapy.

BACKGROUND: Low Back Pain (LBP) remains a common and costly problem. Psychological obstacles to recovery have been identified, but psychological and behavioural interventions have produced only moderate improvements. Reviews of trials have suggested that the interventions lack clear theoretical basis, are often compromised by low dose, lack of fidelity, and delivery by non-experts. In addition, interventions do not directly target known risk mechanisms. We identified a theory driven intervention (Contexual Cognitive Behavioural Therapy, CCBT) that directly targets an evidence-based risk mechanism (avoidance and ensured dose and delivery were optimised. This feasibility study was designed to test the credibility and acceptability of optimised CCBT against physiotherapy for avoidant LBP patients, and to test recruitment, delivery of the intervention and response rates prior to moving to a full definitive trial. METHODS: A randomised controlled feasibility trial with patients randomised to receive CCBT or physiotherapy. CCBT was delivered by trained supervised psychologists on a one to one basis and comprised up to 8 one-hour sessions. Physiotherapy comprised back to fitness group exercises with at least 60 % of content exercise-based. Patients were eligible to take part if they had back pain for more than 3 months, and scored above a threshold indicating fear avoidance, catastrophic beliefs and distress. RESULTS: 89 patients were recruited. Uptake rates were above those predicted. Scores for credibility and acceptability of the interventions met the set criteria. Response rates at three and six months fell short of the 75 % target. Problems associated with poor response rates were identified and successfully resolved, rates increased to 77 % at 3 months, and 68 % at 6 months. Independent ratings of treatment sessions indicated that CCBT was delivered to fidelity. Numbers were too small for formal analysis. Although average scores for acceptance were higher in the CCBT group than in the group attending physiotherapy (increase of 7.9 versus 5.1) and change in disability and pain from baseline to 6 months were greater in the CCBT group than in the physiotherapy group, these findings should be interpreted with caution. CONCLUSIONS: CCBT is a credible and acceptable intervention for LBP patients who exhibit psychological obstacles to recovery. TRIAL REGISTRATION: ISRCTN43733490 , registered 15/12/2010.

A systematic review and meta-synthesis of the impact of low back pain on people's lives.

BACKGROUND: Low back pain (LBP) is a common and costly problem that many interpret within a biopsychosocial model. There is renewed concern that core-sets of outcome measures do not capture what is important. To inform debate about the coverage of back pain outcome measure core-sets, and to suggest areas worthy of exploration within healthcare consultations, we have synthesised the qualitative literature on the impact of low back pain on people's lives. METHODS: Two reviewers searched CINAHL, Embase, PsycINFO, PEDro, and Medline, identifying qualitative studies of people's experiences of non-specific LBP. Abstracted data were thematic coded and synthesised using a meta-ethnographic, and a meta-narrative approach. RESULTS: We included 49 papers describing 42 studies. Patients are concerned with engagement in meaningful activities; but they also want to be believed and have their experiences and identity, as someone 'doing battle' with pain, validated. Patients seek diagnosis, treatment, and cure, but also reassurance of the absence of pathology. Some struggle to meet social expectations and obligations. When these are achieved, the credibility of their pain/disability claims can be jeopardised. Others withdraw, fearful of disapproval, or unable or unwilling to accommodate social demands. Patients generally seek to regain their pre-pain levels of health, and physical and emotional stability. After time, this can be perceived to become unrealistic and some adjust their expectations accordingly. CONCLUSIONS: The social component of the biopsychosocial model is not well represented in current core-sets of outcome measures. Clinicians should appreciate that the broader impact of low back pain includes social factors; this may be crucial to improving patients' experiences of health care. Researchers should consider social factors to help develop a portfolio of more relevant outcome measures.

Designing a primary care pharmacist-led review for people treated with opioids for persistent pain: a multi-method qualitative study.

BACKGROUND: Opioids are frequently prescribed for persistent non-cancer pain despite limited evidence of long-term effectiveness and risk of harm. Evidence-based interventions to address inappropriate opioid prescribing are lacking. AIM: To explore perspectives of people living with persistent pain to understand barriers and facilitators in reducing opioids in the context of a pharmacist-led primary care review, and identify review components and features for optimal delivery. DESIGN & SETTING: Primary care multi-method qualitative study. METHOD: Adults with experience of persistent pain and taking opioids participated in semi-structured interviews (n=15, 73% female) and an online discussion forum (n=31). The Theoretical Domains Framework (TDF) provided a framework for data collection and thematic analysis, involving deductive analysis to TDF domains, inductive analysis within-domains to generate subthemes, and subtheme comparison to form across-domain overarching themes. The behaviour change technique taxonomy v.1 and motivational behaviour change technique classification system were used to systematically map themes to behaviour change techniques to identify potential review components and delivery features. RESULTS: 32 facilitator and barrier subthemes for patients reducing opioids were identified across 13 TDF domains. These combined into six overarching themes: learning to live with pain, opioid reduction expectations, assuming a medical model, pharmacist-delivered reviews, pharmacist-patient relationship and patient engagement. Subthemes mapped to 21 unique behaviour change techniques, yielding 17 components and five delivery features for the proposed PROMPPT review. CONCLUSION: This study generated theoretically-informed evidence for design of a practice pharmacist-led PROMPPT review. Future research will test the feasibility and acceptability of the PROMPPT review and pharmacist training.

Acceptability of a proposed practice pharmacist-led review for opioid-treated patients with persistent pain: A qualitative study to inform intervention development.

Introduction: Regular review of patients prescribed opioids for persistent non-cancer pain (PCNP) is recommended but not routinely undertaken. The PROMPPT (Proactive clinical Review of patients taking Opioid Medicines long-term for persistent Pain led by clinical Pharmacists in primary care Teams) research programme aims to develop and test a pharmacist-led pain review (PROMPPT) to reduce inappropriate opioid use for persistent pain in primary care. This study explored the acceptability of the proposed PROMPPT review to inform early intervention development. Methods: Interviews (n = 15) and an online discussion forum (n = 31) with patients prescribed opioids for PCNP and interviews with pharmacists (n = 13), explored acceptability of a proposed PROMPPT review. A prototype PROMPPT review was then tested and refined through 3 iterative cycles of in-practice testing (IPT) (n = 3 practices, n = 3 practice pharmacists, n = 13 patients). Drawing on the Theoretical Framework of Acceptability (TFA), a framework was generated (including a priori TFA constructs) allowing for deductive and inductive thematic analysis to identify aspects of prospective and experienced acceptability. Results: Patients felt uncertain about practice pharmacists delivering the proposed PROMPPT review leading to development of content for the invitation letter for IPT (introducing the pharmacist and outlining the aim of the review). After IPT, patients felt that pharmacists were suited to the role as they were knowledgeable and qualified. Pharmacists felt that the proposed reviews would be challenging. Although challenges were experienced during delivery of PROMPPT reviews, pharmacists found that they became easier to deliver with time, practise and experience. Recommendations for optimisations after IPT included development of the training to include examples of challenging consultations. Conclusions: Uptake of new healthcare interventions is influenced by perceptions of acceptability. Exploring prospective and experienced acceptability at multiple time points during early intervention development, led to mini-optimisations of the prototype PROMPPT review ahead of a non-randomised feasibility study.

Rehabilitation following surgery for lumbar spinal stenosis.

BACKGROUND: Lumbar spinal stenosis is a common cause of back pain that can also give rise to pain in the buttock, thigh or leg, particularly when walking. Several possible treatments are available, of which surgery appears to be best at restoring function and reducing pain. Surgical outcome is not ideal, and a sizeable proportion of patients do not regain good function. No accepted evidence-based approach to postoperative care is known-a fact thathas prompted this review. OBJECTIVES: To determine whether active rehabilitation programmes following primary surgery for lumbar spinal stenosis have an impact on functional outcomes and whether such programmes are superior to 'usual postoperative care'. SEARCH METHODS: We searched the following databases from their first issues to March 2013: CENTRAL (The Cochrane Library, most recent issue), the Cochrane Back Review Group Trials Register, MEDLINE, EMBASE, CINAHL and PEDro. SELECTION CRITERIA: We considered randomised controlled trials (RCTs) that compared the effectiveness of active rehabilitation versus usual care in adults (> 18 years of age) with confirmed lumbar spinal stenosis who had undergone spinal decompressive surgery (with or without fusion) for the first time. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from the included trials by using a predeveloped form. We contacted authors of original trials to request additional unpublished data as required. We recorded baseline characteristics of participants, interventions, comparisons, follow-up and outcome measures to enable assessment of clinical homogeneity. Clinical relevance was independently assessed by using the five questions recommended by the Cochrane Back Review Group (CBRG), and risk of bias within studies was determined by using CBRG criteria.We pooled individual study results in a meta-analysis when appropriate. For continuous outcomes, we calculated the mean difference (MD) when the same measurement scales were used in all studies and the standardised mean difference (SMD) when different measurement scales were used. Whenreported means and standard deviations of the outcomes showed that outcome data were skewed, we log-transformed data for all studies in the comparison and performed a meta-analysis on the log-scale. Results of analyses performed on the log-scale were converted back to the original scale. We used a fixed-effect inverse variance model to measure treatment effect when no substantial evidence of statistical heterogeneity was found. When we detected substantial statistical heterogeneity, we used a random-effects inverse variance model.The primary outcome measure was functional status as measured by a back-specific functional scale. Secondary outcomes included measures of leg pain, low back pain and global improvement/general health. We considered statistical significance and clinical relevance of outcomes. We used the GRADE approach to assess the overall quality of evidence for each outcome on the basis of five criteria, for which evidence was ranked from high to very low quality, depending on the number of criteria met. MAIN RESULTS: Our searches yielded 1,726 results, and a total of three studies (N = 373 participants) were included in the review and meta-analysis. All studies were deemed to have low risk of bias; no study had unacceptably high dropout rates. Also, no unacceptably unbalanced dropout rates, unacceptably low adherence rates or non-adherence to the protocol or clearly significant unbalanced baseline differences were noted for the primary outcome. Outcomes in the short term (within six months postoperative)Evidence of moderate quality from three RCTs (N = 340) shows that active rehabilitation is more effective than usual care for functional status (log SMD -0.22, 95% confidence interval (CI) -0.44 to 0.00, corresponding to an average percentage improvement (reduction in standardised functional score) of 20%, 95% CI 0% to 36%) and for reported low back pain (log MD -0.18, 95% CI-0.35 to -0.02, corresponding to an average percentage improvement (reduction in VAS score) of 16%, 95% CI 2% to 30%). In contrast, evidence of low quality suggests that rehabilitation is no more effective than usual care for leg pain (log MD -0.17, 95% CI -0.52 to 0.19, corresponding to an average percentage improvement (reduction in VAS score) of 16%, 95% CI 21% worsening to 41% improvement). Low-quality evidence from two RCTs (N = 238) indicates that rehabilitation has no additional benefit on general health status as compared to usual care (MD 1.30, 95% CI -4.45 to 7.06). Outcomes in the long term (at 12 months postoperative)Evidence of moderate quality from three RCTs (N = 373) shows that rehabilitation is more effective than usual care for functional status (log SMD -0.26, 95% CI -0.46 to -0.05, corresponding to an average percentage improvement (reduction in standardised functional score) of 23%, 95% CI 5% to 37%), for reported low back pain (log MD -0.20, 95% CI -0.36 to -0.05, corresponding to an average percentage improvement (reduction in VAS score) of 18%, 95% CI 5% to 30%]. Evidence of moderate quality (N = 373) and for leg pain (log MD -0.24, 95% CI -0.47 to -0.01, corresponding to an average percentage improvement (reduction in VAS score) of 21%, 95% CI 1% to 37%). In contrast, evidence of low quality from two studies (N = 273) suggests that rehabilitation is no more effective than usual care with respect to improvement in general health (MD -0.48, 95% CI -6.41 to 5.4).None of the included papers reported any relevant adverse events. AUTHORS' CONCLUSIONS: Evidence suggests that active rehabilitation is more effective than usual care in improving both short- and long-term (back-related) functional status. Similar findings were noted for secondary outcomes, including short-term improvement in low back pain and long-term improvement in both low back pain and leg pain, although limited impact was observed in relation to improvements in general health status. The clinical relevance of these effects is medium to small. Our evaluation is limited by the small number of relevant studies identified, and further research is required.

Cross-cultural adaptation and validation of the Hebrew version of the Injustice Experience Questionnaire - long and short versions.

PURPOSE: To translate, validate, and culturally adapt the Injustice Experience Questionnaire (IEQ) and IEQ Short Form (IEQ-SF) into Hebrew, as measuring tools for examining feelings of injustice in cases of accidents and chronic pain. METHODS: The translation was performed in several steps following the cross-cultural adaptation process. A sample of 150 patients suffering from traumatic injury fill out a battery of questionnaires: IEQ, IEQ-SF, Hospital Anxiety and Depression Scale (HADS), Numeric Pain Rating Scale (NPRS), and Pain Catastrophizing Scale (PCS), which were used for calculating construct validity. A test-retest was performed on 41 patients. RESULTS: The IEQ and IEQ-SF found Cronbach's alpha of 0.92 and 0.84, respectively. Test-retest reliability for IEQ (ICC: 0.94) was found to be excellent. Spearman's correlation coefficient between IEQ and PCS was 0.68, NPRS (severe pain: 0.45, average pain: 0.51), HADS (anxiety: 0.62, depression: 0.60). The correlation between IEQ-SF and PCS was 0.67, with HADS (anxiety: 0.52, depression: 0.48). A weak correlation was found for NPRS (severe pain: 0.30, average pain: 0.34). CONCLUSIONS: The Israeli translation and cross-cultural adaptation of the IEQ and IEQ-SF questionnaires were found to be valid and reliable.Implications for rehabilitationThe perception of injustice is a significant mental and psychological factor for recovery after accidents and injuries.This study translated, validated and culturally adapted the Injustice Experience Questionnaire (IEQ) and the short form into Hebrew.The questionnaires were found to be valid and reliable in Hebrew.

Predicting persisting disability in musculoskeletal pain patients with the STarT MSK screening tool: Results from a prospective cohort study.

BACKGROUND: The STarT MSK screening tool aims to categorise musculoskeletal patients into three risk groups for treatment stratification. The tool has been translated and validated into Hebrew. However, its ability to predict persistent disability in patients has yet to be evaluated. OBJECTIVE: The primary aim of this study was to assess the ability of the Hebrew version of the STarT MSK tool to predict persistent disability in patients experiencing musculoskeletal pain. METHODS: A prospective observational cohort study was conducted, recruiting 135 patients with musculoskeletal pain in five common areas: back, neck, shoulder, knee, or multisite pain over the age of 21. At the first consultation, all patients completed demographic information, the Focus On Therapeutic Outcomes (FOTO) questionnaire (function, pain, and fear avoidance score), and the STarT MSK questionnaire. The patients completed the FOTO questionnaire again at the end of the physiotherapy treatments. RESULTS: 25 patients (18.5%) were classified into the low-risk group, 68 patients (50.3%) into the medium-risk group, and 42 (31.1%) into the high-risk group. The baseline STarT MSK tool score demonstrated an excellent ability to identify patients at high risk of developing persistent disability (AUC = 0.795, 95% CI 0.716-0.873). CONCLUSIONS: The Hebrew version of the STarT MSK tool can differentiate between three chronic risk groups and has high predictive validity for chronicity. This may provide a tool to assist clinicians in identifying patients who require more intensive care, and thus, potentially prevent the transition to chronic disabling pain.