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.

"Listen to me, learn from me": a priority setting partnership for shaping interdisciplinary pain training to strengthen chronic pain care.

ABSTRACT: What are the care-seeking priorities of people living with chronic pain and carers and how can these shape interdisciplinary workforce training to improve high-value pain care? Phase 1: Australian people living with chronic pain (n = 206; 90% female) and carers (n = 10; 40% female) described their pain care priorities (eDelphi, round 1). A coding framework was inductively derived from 842 pain care priorities (9 categories, 52 priorities), including validation; communication; multidisciplinary approaches; holistic care; partnerships; practitioner knowledge; self-management; medicines; and diagnosis. Phase 2: In eDelphi round 2, panellists (n = 170; valid responses) rated the importance (1 = less important; 9 = more important) of the represented framework. In parallel, cross-discipline health professionals (n = 267; 75% female) rated the importance of these same priorities. Applying the RAND-UCLA method (panel medians: 1-3: "not important," 4-6: "equivocal," or 7-9: "important"), "important" items were retained where the panel median score was >7 with panel agreement ≥70%, with 44 items (84.6%) retained. Specific workforce training targets included the following: empathic validation; effective, respectful, safe communication; and ensuring genuine partnerships in coplanning personalised care. Panellists and health professionals agreed or strongly agreed (95.7% and 95.2%, respectively) that this framework meaningfully reflected the importance in care seeking for pain. More than 74% of health professionals were fairly or extremely confident in their ability to support care priorities for 6 of 9 categories (66.7%). Phase 3: An interdisciplinary panel (n = 5) mapped an existing foundation-level workforce training program against the framework, identifying gaps and training targets. Recommendations were determined for framework adoption to genuinely shape, from a partnership perspective, Australian interdisciplinary pain training.

Patients' conceptions of undergoing physiotherapy for persistent low back pain delivered in Finnish primary healthcare by physiotherapists who had participated in brief training in cognitive functional therapy.

PURPOSE: To explore the conceptions of patients with persistent low back pain (LBP) of undergoing physiotherapy delivered in Finnish primary healthcare by physiotherapists who had participated in brief training in Cognitive Functional Therapy (CFT). METHODS: As part of a feasibility implementation study exploring CFT in management of LBP in the Finnish primary healthcare system, we interviewed nine patients from four geographical areas in Finland after receiving care. We used a phenomenographic approach to explore the variation in their conceptions. RESULTS: The analysis revealed four descriptive categories: "hung out to dry," "stuck," "making sense and taking control," and "holistic approach to care and living," that varied based on six themes. CONCLUSIONS: Although the participants accepted this approach to care well, there was significant variation in patients' conceptions. Restricted access to care within the healthcare system and a lack of social support led some of them to feel they had been left alone to suffer with their pain. On the other hand, based on the results of this study, positive experiences of physiotherapy and good collaboration with the physiotherapist, wider social support outside of physiotherapy, a better understanding of the multidimensional nature of pain and the acquisition of self-management skills were reported as positive aspects of undergoing physiotherapy that may be related to positive treatment outcomes.Implications for rehabilitationThe participants of this study saw undergoing physiotherapy delivered within biopsychosocial framework as different from their previous physiotherapy experiences and for some the process ended with feeling empty-handed and for others it could be a turning point in their lives.This study encourages the health care providers to create flexible care pathways and ongoing support for more vulnerable individuals so that they don't feel abandoned by the system.Professionals could also pay attention to building strong therapeutic alliance, help patients understand pain in biopsychosocial framework, take into consideration social support networks of the patients, and support patients toward effective self-management strategies.

Cognitive functional therapy in patients with non-specific chronic low back pain-a randomized controlled trial 3-year follow-up.

OBJECTIVES: This randomized controlled trial investigated the efficacy of cognitive functional therapy (CFT) compared with manual therapy and exercise (MT-EX) for people with non-specific chronic low back pain (NSCLBP) at 3-year follow-up. METHODS: Hundred and twenty-one patients were randomized to CFT (n = 62) or MT-EX (n = 59). Three-year data were available for 30 (48.4%) participants in the CFT group, and 33 (55.9%) participants in the MT-EX group. The primary outcomes were disability (Oswestry disability Index [ODI]) and pain intensity (numerical rating scale) and secondary outcomes were anxiety/depression (Hopkins Symptoms Checklist) and pain-related fear (Fear-Avoidance Belief Questionnaire). A full intention to treat analysis was conducted using linear mixed models. RESULTS: Significantly greater reductions in disability were observed for the CFT group, with ODI scores at 3 years 6.6 points lower in the CFT than the MT-EX group (95%CI:-10.1 to -3.1, p < 0.001, standardized effect size = 0.70). There was no significant difference in pain intensity between the groups at 3 years (0.6 points 95%CI:-1.4-0.3, p = 0.195). Significantly greater reductions were also observed for the CFT group for Hopkins Symptoms Checklist and Fear-Avoidance Belief Questionnaire (Work). CONCLUSIONS: CFT is more effective at reducing disability, depression/anxiety and pain-related fear, but not pain, at 3-year follow-up than MT-EX. SIGNIFICANCE: Cognitive functional therapy (CFT) was more effective than manual therapy and exercise (MT-EX) in reducing disability at 3-year follow-up, in people with non-specific chronic low back pain. The sustained reduction in disability without concomitant reductions in pain intensity in the CFT group suggests a de-coupling of the pain-disability relationship. CFT resulted in long-lasting reductions in anxiety and depression, and pain-related fear regarding work compared to MT-EX. The findings support the long-term benefits of a individualized behaviourally orientated intervention that targets pain beliefs, functional restoration and lifestyle factors.

Comparative Effectiveness of Conservative Interventions for Nonspecific Chronic Spinal Pain: Physical, Behavioral/Psychologically Informed, or Combined? A Systematic Review and Meta-Analysis.

UNLABELLED: Nonspecific chronic spinal pain (NSCSP) is highly disabling. Current conservative rehabilitation commonly includes physical and behavioral interventions, or a combination of these approaches. Physical interventions aim to enhance physical capacity by using methods such as exercise, manual therapy, and ergonomics. Behavioral/psychologically informed interventions aim to enhance behaviors, cognitions, or mood by using methods such as relaxation and cognitive behavioral therapy. Combined interventions aim to target physical and also behavioral/psychological factors contributing to patients' pain by using methods such as multidisciplinary pain management programs. Because it remains unclear whether any of these approaches are superior, this review aimed to assess the comparative effectiveness of physical, behavioral/psychologically informed, and combined interventions on pain and disability in patients with NSCSP. Ten electronic databases were searched for randomized controlled trials (RCTs) including participants reporting NSCSP. Studies were required to have an "active" conservative treatment control group for comparison. Studies were not eligible if the interventions were from the same domain (eg, if the study compared 2 physical interventions). Study quality was assessed used the Cochrane Back Review Group risk of bias criteria. The treatment effects of physical, behavioral/psychologically informed, and combined interventions were assessed using meta-analyses. Twenty-four studies were included. No clinically significant differences were found for pain and disability between physical, behavioral/psychologically informed, and combined interventions. The simple categorization of interventions into physical, behavioral/psychologically informed, and combined could be considered a limitation of this review, because these interventions may not be easily differentiated to allow accurate comparisons to be made. Further work should consider investigating whether tailoring rehabilitation to individual patients and their perceived risk of chronicity, as seen in recent RCTs for low back pain, can enhance outcomes in NSCSP. PERSPECTIVE: In this systematic review of RCTs in NSCSP, only small differences in pain or disability were observed between physical, behavioral/psychologically informed, and combined interventions.

Mindfulness-Based Functional Therapy: a preliminary open trial of an integrated model of care for people with persistent low back pain.

OBJECTIVES: This pilot study investigated the feasibility and clinical utility of implementing a novel, evidence-informed, interdisciplinary group intervention-Mindfulness Based Functional Therapy (MBFT)-for the management of persistent low back pain (LBP) in primary care. MBFT aimed to improve physical and psychological functioning in patients with persistent LBP. DESIGN: A single-group repeated measures design was utilized to gather data about feasibility, effect sizes, clinically significant changes and patient satisfaction. SETTING: A community sample of 16 adults (75% female), mean (SD) age 47.00 (9.12) years (range 26-65 years), with mean (SD) LBP duration of 8.00 (9.00) years participated, using a simulated primary care setting at Curtin University in Australia. INTERVENTION: MBFT is an 8-week group intervention co-facilitated by psychology and physiotherapy disciplines. Content includes: mindfulness meditation training, cognitive-functional physiotherapeutic movement retraining, pain education, and group support. MAIN OUTCOME MEASURES: Several validated self-report measures were used to assess functional disability, emotional functioning, mindfulness, pain catastrophizing, health-related quality of life at baseline, post-intervention, and 6 months follow-up. RESULTS: Adherence and satisfaction was high, with 85% of participants highly satisfied with MBFT. Clinical significance analysis and effect size estimates showed improvements in a number of variables, including pain catastrophizing, physical functioning, role limitations due to physical condition, and depression, although these may have occurred due to non-intervention effects. CONCLUSIONS: MBFT is feasible to implement in primary care. Preliminary findings suggest that a randomized controlled trial is warranted to investigate its efficacy in improving physical and emotional functioning in people with disabling persistent LBP.

Investigating the effect of real-time spinal postural biofeedback on seated discomfort in people with non-specific chronic low back pain.

A total of 24 participants with non-specific chronic low back pain (NSCLBP) sat for 2 h while their seated posture and low back discomfort (LBD) were analysed. A total of 16 pain developers (PDs), whose LBD increased by at least two points on the numeric rating scale, repeated the procedure 1 week later, while receiving postural biofeedback. PDs were older (p = 0.018), more disabled (p = 0.021) and demonstrated greater postural variability (p < 0.001). The ramping up of LBD was reduced (p = 0.002) on retesting, when sitting posture was less end-range (p < 0.001), and less variable (p = 0.032). Seated LBD appears to be related with modifiable characteristics such as sitting behaviour. Among people with sitting-related NSCLBP, the ramping up of LBD was reduced by modifying their sitting behaviour according to their individual clinical presentation. The magnitude of change, while statistically significant, was small and no follow-up of participants was completed. Further research should examine integrating biofeedback into comprehensive biopsychosocial management strategies for NSCLBP. PRACTITIONER SUMMARY: The effect of real-time postural biofeedback on LBD was examined among people with LBP. Postural biofeedback matched to the individual clinical presentation significantly reduced LBD within a single session. Further research should examine the long-term effectiveness of postural biofeedback as an intervention for LBP.

The effects of manual pelvic compression on trunk motor control during an active straight leg raise in chronic pelvic girdle pain subjects.

A sub-group of pelvic girdle pain (PGP) patients with a positive active straight leg raise (ASLR) responds positively to the application of external pelvic compression during the test. This study investigated the effect of this phenomenon on electromyographic (EMG) activity of the trunk muscles and intra-abdominal and intra-thoracic pressures in subjects with a unilateral sacroiliac joint (SIJ) pain disorder (n=12). All subjects reported reduced difficulty ratings during an ASLR with pelvic compression (paired t-test: p<0.001), yet no statistically significant changes in the muscle activation or pressure variables were found. However, visual inspection of the data revealed two divergent motor control strategies with the addition of compression. Seven subjects displayed characteristics of a decreased EMG profile, while in the other five subjects the EMG profile appeared to increase. As such this study provides preliminary evidence of two disparate patterns of motor control in response to the addition of pelvic compression to an ASLR. The findings may reflect different mechanisms, not only in the response to pelvic compression, but also of the underlying PGP disorder.