Elsevier

The Lancet

Volume 401, Issue 10391, 3–9 June 2023, Pages 1866-1877
The Lancet

Articles
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

https://doi.org/10.1016/S0140-6736(23)00441-5Get rights and content

Summary

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.

Introduction

Most people with an episode of low back pain improve rapidly, but 20–30% develop chronic pain lasting more than 3 months, with high levels of disability.1 Low back pain is the greatest contributor to years lived with disability globally,2 a burden primarily resulting from people with persistent pain and high disability.2 The societal costs of chronic pain exceed that of cancer and diabetes combined,3 and most costs from chronic low back pain are due to loss of work participation and on-going care-seeking. Existing treatment approaches for people with low back pain are inadequate, with low back pain-related disability continuing to increase.2

Chronic low back pain is widely considered a complex multifactorial biopsychosocial condition.2 Guidelines recommend that both physical and psychological contributors be addressed when treating people with chronic low back pain;4 yet, most interventions do not address the various factors contributing to an individual's pain and associated disability. Consequently, the treatment effects of most recommended interventions such as exercise or psychological therapies are modest in size and tend to be of short duration.5, 6 Even intensive multidisciplinary biopsychosocial rehabilitation programmes, which are costly and resource intensive, show small to moderate effects that are mostly short to medium term.7

Research in context

Evidence before this study

We searched four electronic databases (Cochrane CENTRAL, CINAHL, MEDLINE, and Embase) from inception up to Sept 27, 2022, without language restrictions, using a modified Cochrane Collaboration search strategy. That strategy used diverse search terms for low back pain (eg, “back pain”, “low back pain”, and “lumbago”), cognitive functional therapy (CFT; eg, “cognitive functional therapy” and “cognitive behavioural therapy”), and randomised controlled trials (eg, “controlled clinical trial” and “randomised”). We identified four randomised controlled trials of individualised CFT (reported in five papers). All four trials were judged to be of moderate risk of bias (scores 6–7 on 0–10 PEDro scale). Control interventions included manual therapy and exercise, group-based exercise and education, and no treatment. One study was inadequately powered (n=36), two showed persistent effects favouring CFT for reducing pain-related activity limitation (disability) up to 12 months' follow-up, and one did not show significant effects beyond the end of the treatment period. Three studies compared CFT with other interventions. Two reported on activity limitation up to 3 months and their pooled effects were a standardised mean difference of 0·89 (95% CI –0·03 to 1·81), a potentially large effect. Three reported long-term outcomes at 12 months and their pooled effects were a standardised mean difference of 0·44 (0·01 to 0·77), a moderate effect. We found considerable heterogeneity and imprecision at both timepoints. We found no high quality randomised controlled trials comparing CFT with usual primary care, no trials that included an analysis of economic efficiency, nor any that explored the potential added effect of movement sensor biofeedback.

Added value of this study

To the best of our knowledge, the RESTORE trial is the largest clinical trial of CFT and its findings indicate that this treatment resulted in substantial clinically important effects in both the short term and long term, when compared with usual care. CFT was effective for the primary outcome of activity limitation and all of the secondary outcome measures. The large effect sizes persisted to the end of the follow-up period (12 months), which is unusual in chronic low back pain. The use of wearable sensor biofeedback did not add to effectiveness. CFT was also much more cost-effective from a societal perspective than usual care.

Implications of all the available evidence

CFT might offer a high-value, low-risk, and low-cost clinical pathway for patients with persistent disabling low back pain. The results of this study have ramifications for the management of low back pain in primary care and might have implications for the training of all health-care professionals who deliver care for people with chronic disabling low back pain.

Cognitive functional therapy (CFT) is a patient-centred approach that facilitates patients to self-manage by targeting their individual pain-related cognitions, emotions, and behaviours that contribute to their pain and disability. A previous small trial8 of CFT (n=121) compared with best-practice manual therapy and exercise provided preliminary evidence of large and sustained effects (12-month disability standardised mean differences [SMDs] 1·0). Similarly, a larger trial of individualised CFT (n=206) compared with group-based exercise and pain education provided evidence of sustained effects (12-month disability SMD 0·6);9 however, both trials had high rates of loss-to-follow-up. By contrast, a trial10 comparing CFT with exercise and manual therapy found a small, non-statistically significant effect at 12 months (disability SMD 0·2). As no large trial has compared CFT with usual care (current practice) and no trials have assessed cost efficiency, there was a clear need for a large rigorous trial investigating the effectiveness and economic efficiency of CFT relative to usual care.

A key distinguishing feature of CFT, compared with other psychologically informed approaches such as cognitive behavioural therapy, is that CFT addresses pain-provocative movement patterns that contribute to low back pain, such as protective muscle guarding and movement avoidance. Wearable movement sensors enable clinicians to easily measure such movements and explore their relationship to pain, both in the clinical setting and during patients' normal activities at work and recreation. Via biofeedback, this technology can help patients to develop an awareness of how they move during normal activities, enhancing their ability to correct unhelpful movement habits. A pilot randomised controlled trial11 (n=112) of patients with chronic low back pain showed that individualised rehabilitation, which included the wearing of wireless movement sensors, resulted in large and sustained clinical improvements compared with guideline-recommended treatment (12-month SMDs 0·5–1·0). No trials have investigated whether wearable sensors can enhance the effects of CFT.

This three-arm randomised controlled trial aimed to compare the effectiveness and economic efficiency of individualised CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain.

Section snippets

Study design and participants

The RESTORE study was a randomised, controlled, three-arm parallel group, phase 3, clinical trial. Treatment was delivered in 20 primary care physiotherapy clinics in Perth (WA) and Sydney (NSW), Australia.

Eligible participants were adults (aged ≥18 years) with chronic low back pain lasting more than 3 months, who had sought care from a primary care clinician for their back pain at least 6 weeks previously, had an average back pain intensity of 4 or more on a 0–10 numerical pain rating scale,

Results

Between Oct 23, 2018, and Aug 3, 2020, we assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, we recruited 492 (48·7%) patients; 164 were randomly assigned to CFT only, 163 to CFT plus biofeedback, and 165 to usual care (figure 1). Of these patients, 160 (33%) declined consent for their Medicare claims data and Pharmaceutical Benefits Scheme data extractions, which were non-compulsory for ethics reasons (70 [42%] of 165 in the usual care group, 45 [27%] of

Discussion

CFT only and CFT plus biofeedback treatments both resulted in large clinically important effects for the primary outcome of pain-related activity limitation at 13 weeks, compared with usual care, and these treatments were substantially less costly from a societal perspective. Those effects were sustained until the 52-week final follow-up. We found no apparent benefit when CFT was supplemented with movement sensors. The findings were similar across all the secondary clinical outcomes, increasing

Data sharing

The study protocol, participant consent and information forms, de-identified individual participant data, the data dictionary, and statistical code can be made available by request to the corresponding author. Access will require submission of a protocol, approval by our review committee, and the signing of a data access agreement. Potential access will be for the period beginning 9 months and ending 36 months following publication of this Article. We are not able to provide access to the

Declaration of interests

PO, JPC, RS, and KO have received speaker fees for lectures or workshops on the biopsychosocial management of pain, including on CFT, from special interest physiotherapy groups and multi-disciplinary audiences of clinicians and researchers. MH and JH have received speaker fees for lectures or workshops on management of pain from audiences of clinicians or patient-representative groups. PO and JPC are clinical directors of a physiotherapy clinic that uses CFT. RS has received a part-time salary

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