Cognitive Functional Therapy compared with usual physiotherapy care in people with persistent low back pain: a mixed methods feasibility randomised controlled trial in the United Kingdom National Health Service.

OBJECTIVES: To determine the feasibility of completing a definitive randomised controlled trial (RCT), evaluating the clinical and cost-effectiveness of Cognitive Functional Therapy (CFT) in comparison to usual physiotherapy care (UPC), for people with persistent low back pain (LBP). DESIGN AND SETTING: A two-arm parallel feasibility RCT completed in a United Kingdom (UK) Secondary Care National Health Service (NHS) physiotherapy service. PARTICIPANTS: Sixty adult participants who reported LBP lasting for more than three months, that was not attributable to a serious (e.g. cancer) or specific (e.g. radiculopathy) underlying cause, were invited to participate. Participants were allocated at random to receive CFT or UPC. INTERVENTIONS: Cognitive Functional Therapy and Usual Physiotherapy Care for persistent LBP. MAIN OUTCOME MEASURES: The primary outcome was the feasibility of completing a definitive RCT, defined by recruitment of at least 5 participants per month, delivery of CFT per protocol and securing relevant and acceptable outcome measures. Data concerning study processes, resources, management and participant reported outcome measures were collected at baseline, 3, 6 and 12-month follow-up. RESULTS: Sixty participants (n = 30 CFT and n = 30 UPC) were recruited with 80% (n = 48), 72% (n = 43) and 53% (n = 32) retained at 3, 6 and 12-month follow-up respectively. NHS physiotherapists were trained to competence and delivered CFT with fidelity. CFT was tolerated by participants with no adverse events. Relevant and clinically important outcome data were collected at all time points (0.4%, 3%, 1% and 0.8% of data was missing from the returned outcome measure booklets at baseline and 3, 6 and 12-month follow-up respectively). The Roland-Morris disability questionnaire was considered the most suitable primary outcome measure with a proposed sample size of 540 participants for a definitive cluster RCT. CONCLUSION: It is feasible to conduct a randomised study of CFT in comparison to UPC for NHS patients. A future study should incorporate an internal pilot to address aspects of feasibility further, including participant retention strategies. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN12965286 CONTRIBUTION OF THE PAPER.

Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial.

BACKGROUND: Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualised approach that targets unhelpful pain-related cognitions, emotions, and behaviours that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects. We aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain. METHODS: RESTORE was a randomised, controlled, three-arm, parallel group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study's questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001396213. FINDINGS: Between Oct 23, 2018 and Aug 3, 2020, we assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, we randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference -4·6 [95% CI -5·9 to -3·4] and CFT plus biofeedback mean difference -4·6 [-5·8 to -3·3]) for activity limitation at 13 weeks (primary endpoint). Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; -AU$5276 [-10 529 to -24) and -8211 (-12 923 to -3500). INTERPRETATION: CFT can produce large and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care. FUNDING: Australian National Health and Medical Research Council and Curtin University.

Complementary and alternative medicine use among older adults with musculoskeletal pain: findings from the European Social Survey (2014) special module on the social determinants of health.

BACKGROUND: This study describes the use of complementary and alternative medicine (CAM) among older adults who report being hampered in daily activities due to musculoskeletal pain. The characteristics of older adults with debilitating musculoskeletal pain who report CAM use is also examined. METHODS: Cross-sectional European Social Survey Round 7 data from 21 countries were examined for participants aged 55 years and older, who reported musculoskeletal pain that hampered daily activities in the past 12 months. RESULTS: Of the 4950 older adult participants reporting musculoskeletal pain that hampered daily activities, the majority (63.5%) were from the West of Europe, reported secondary education or less (78.2%), and reported at least one other health-related problem (74.6%). In total, 1657 (33.5%) reported using at least one CAM treatment in the previous year. Manual body-based therapies (MBBTs) were most used, including massage therapy (17.9%) and osteopathy (7.0%). Alternative medicinal systems (AMSs) were also popular with 6.5% using homoeopathy and 5.3% reporting herbal treatments. A general trend of higher CAM use in younger participants was noted. CAM use was associated with physiotherapy use, female gender, higher levels of education, being in employment and living in West Europe. Those reporting multiple health problems were more likely to use all CAM treatments, except MBBT. CONCLUSION: A third of older Europeans with musculoskeletal pain report CAM use in the previous 12 months. Certain subgroups with higher rates of CAM use could be identified. Clinicians should comprehensively and routinely assess CAM use among older adults with musculoskeletal pain.

RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.

INTRODUCTION: Low back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP. METHODS AND ANALYSIS: Pragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L . ETHICS AND DISSEMINATION: Approved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).

Musculoskeletal pain in Primary Care Physiotherapy: Associations with demographic and general health characteristics.

BACKGROUND: Many patients reporting musculoskeletal pain present to Primary Care Physiotherapy with costly comorbid overlapping complaints that remain medically unexplained. These subjective health complaints (SHC) incorporate coexisting multi-site musculoskeletal pain and varied non-musculoskeletal complaints (e.g. anxiety, tiredness). The role of these non-musculoskeletal complaints is acknowledged in spinal musculoskeletal disorders, but less so for peripheral musculoskeletal disorders. OBJECTIVE: This cross-sectional study explored the relationships between self-reported musculoskeletal pain sites, non-musculoskeletal complaints and disability among people reporting spinal or peripheral musculoskeletal pain. METHODS: Fifty individuals with spinal musculoskeletal pain and fifty with peripheral musculoskeletal pain provided data on disability, number of musculoskeletal pain sites and non-musculoskeletal complaints. Relationships between these variables were examined for each group using Pearson's correlation coefficient and linear regression analysis. RESULTS: Participants with spinal musculoskeletal pain recorded significantly more pain sites and non-musculoskeletal complaints than participants with peripheral musculoskeletal pain. However, there was no significant difference in disability between the groups. Non-musculoskeletal complaints were significantly associated with disability (correlation = 0.41, p < 0.01) and number of pain sites (correlation = 0.42, p < 0.01). Number of pain sites and disability were not significantly associated in either group. Participants with spinal musculoskeletal pain reported more tiredness, dizziness, anxiety and sleep problems. Participants reporting dizziness, anxiety, sadness/depression and sleep problems had higher disability. CONCLUSION: Further studies must confirm the robustness of these associations, to permit comparisons between clinical and general populations and aid identification of causal factors. Considering SHC within individualised management programmes may improve outcomes.

The effect of a dynamic chair on seated energy expenditure.

Dynamic sitting approaches have been advocated to increase seated energy expenditure with the view of lessening the sedentary nature of the task. This study compared energy expenditure (EE) and overall body discomfort on a novel dynamic chair with a standard office chair. Fifteen pain-free participants completed a DVD viewing task on both chairs in a randomised order. Energy expenditure and discomfort were collected simultaneously. Linear mixed models were used to analyse steady-state EE recorded on each of the chairs. Differences in discomfort were analysed using Wilkoxon Signed Rank Tests. Sitting on the novel dynamic chair significantly (p = 0.005) increased energy expenditure compared to a standard office chair. The discomfort experienced was mild overall, but was significantly greater on the dynamic chair (p = 0.004). Whilst the EE was seen to be significantly higher on the dynamic chair, the MET values are still below 1.5 METS. Thus, the use of a dynamic chair does not seem to be the most effective measure to prevent sedentary behaviour. Practitioner Summary: Sitting on a dynamic chair increased energy expenditure compared to sitting on a standard office chair among pain-free participants. Whilst the EE was seen to be significantly higher on the dynamic chair, the MET values are still below 1.5 METS (low level EE).

Understanding pain among older persons: Part 2-the association between pain profiles and healthcare utilisation.

Background: While polypharmacy and multimorbidity predict healthcare utilisation among older people, the influence of differing pain profiles on healthcare utilisation is unclear. Objective: To compare healthcare utilisation between people with different pain profiles. Methods: Baseline data from The Irish LongituDinal study on Ageing (TILDA), a population-representative cohort study involving over 8,171 community living people resident in Ireland aged 50 or over, was used. Following the creation of four novel pain profiles, variables relating to healthcare utilisation were compared across the different profiles using chi-square tests and logistic regression. Results: Healthcare utilisation differed across the four pain profiles, with pain being an independent predictor of resource use. Pain profiles 3 and 4 had higher use of general practitioner (GP) care and outpatient visits than people with no pain and pain that had less impact. The odds of being a frequent GP attender increased across pain profiles, with those in profile 4 being almost three times as likely to be frequent attenders compared to those with no pain (adjusted odds ratio (OR) = 2.79; 95% CI 2.74, 2.83). People in profile 4 were almost twice as likely to have a hospital outpatient visit compared to people with no pain (adjusted OR = 1.75; 95% 1.73, 1.78). Conclusions: Healthcare utilisation differed between the four pain profiles, with people in profiles 3 and 4 having greater usage of primary and secondary healthcare resources. Pain profile membership was a significant independent predictor of the utilisation of GP care and hospital outpatient visits.