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Randomized Controlled Trial
. 2022 Aug 2;328(5):430-439.
doi: 10.1001/jama.2022.9930.

Effect of Graded Sensorimotor Retraining on Pain Intensity in Patients With Chronic Low Back Pain: A Randomized Clinical Trial

Affiliations
Randomized Controlled Trial

Effect of Graded Sensorimotor Retraining on Pain Intensity in Patients With Chronic Low Back Pain: A Randomized Clinical Trial

Matthew K Bagg et al. JAMA. .

Abstract

Importance: The effects of altered neural processing, defined as altering neural networks responsible for perceptions of pain and function, on chronic pain remains unclear.

Objective: To estimate the effect of a graded sensorimotor retraining intervention (RESOLVE) on pain intensity in people with chronic low back pain.

Design, setting, and participants: This parallel, 2-group, randomized clinical trial recruited participants with chronic (>3 months) nonspecific low back pain from primary care and community settings. A total of 276 adults were randomized (in a 1:1 ratio) to the intervention or sham procedure and attention control groups delivered by clinicians at a medical research institute in Sydney, Australia. The first participant was randomized on December 10, 2015, and the last was randomized on July 25, 2019. Follow-up was completed on February 3, 2020.

Interventions: Participants randomized to the intervention group (n = 138) were asked to participate in 12 weekly clinical sessions and home training designed to educate them about and assist them with movement and physical activity while experiencing lower back pain. Participants randomized to the control group (n = 138) were asked to participate in 12 weekly clinical sessions and home training that required similar time as the intervention but did not focus on education, movement, and physical activity. The control group included sham laser and shortwave diathermy applied to the back and sham noninvasive brain stimulation.

Main outcomes and measures: The primary outcome was pain intensity at 18 weeks, measured on an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]) for which the between-group minimum clinically important difference is 1.0 point.

Results: Among 276 randomized patients (mean [SD] age, 46 [14.3] years; 138 [50%] women), 261 (95%) completed follow-up at 18 weeks. The mean pain intensity was 5.6 at baseline and 3.1 at 18 weeks in the intervention group and 5.8 at baseline and 4.0 at 18 weeks in the control group, with an estimated between-group mean difference at 18 weeks of -1.0 point ([95% CI, -1.5 to -0.4]; P = .001), favoring the intervention group.

Conclusions and relevance: In this randomized clinical trial conducted at a single center among patients with chronic low back pain, graded sensorimotor retraining, compared with a sham procedure and attention control, significantly improved pain intensity at 18 weeks. The improvements in pain intensity were small, and further research is needed to understand the generalizability of the findings.

Trial registration: ANZCTR Identifier: ACTRN12615000610538.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Bagg reported receiving grants from the Australian National Health and Medical Research Council (ID1087045), the Australian government (Australian Research Training Program Scholarship), the University of New South Wales (UNSW Research Excellence Award), and Neuroscience Research Australia (PhD supplementary scholarship) and nonfinancial support from Neuro Orthopaedic Institute (Noigroup) (gratis attendance at 2 Explain Pain courses in 2015; gratis access to Explain Pain, Explain Pain Protectometer, and Recognise materials) during the conduct of the study and personal fees from Chiropractor’s Association of Australia (conference travel, webinars), Memorial University of Newfoundland (conference travel), and Active Linc Pty Ltd (workshop) outside the submitted work. Dr Wand reported receiving personal fees from Manual Concepts outside the submitted work. Dr Stanton reported receiving grants from National Health & Medical Research Council of Australia during the conduct of the study; grants from Arthritis Australia, Arthritis SA, Australia Pain Society/Australia Pain Relief Association/Cops for Kids, and National Health & Medical Research Council of Australia outside the submitted work; and royalties for books on pain education and rehabilitation from NOIgroup publications and has received payment for lectures provided on pain and rehabilitation. Dr O’Connell reported receiving grants from the National Institute for Health and Care Research (UK), the Alzheimer’s Society, and the Campbell Collaboration/Youth Endowment Fund and has received speakers fees for lectures provided on evidence in pain from the San Diego Pain Summit. Dr O’Hagan reported receiving grants from Australian Commonwealth Government Research Training Program and Neuroscience Research Australia during the conduct of the study. Mr Rizzo reported receiving research tuition fees from the University of New South Wales and PhD supplementary scholarship from Neuroscience Research Australia during the conduct of the study. Mr Wewege reported receiving grants from National Health and Medical Research Council Postgraduate Scholarship, University of New South Wales School of Medical Sciences Top-Up Scholarship, and Neuroscience Research Australia (PhD supplementary scholarship) during the conduct of the study. Dr Rabey reported receiving grants from Neuroscience Research Australia during the conduct of the study. Dr Goodall reported receiving grants from the government during the conduct of the study. Dr Maher reported receiving grants from National Health and Medical Research Council during the conduct of the study and nonfinancial support from Flexeze, which provided heat wraps at no cost for the SHaPED trial outside the submitted work. Dr Moseley reported receiving grants from National Health and Medical Research Council of Australia General (salary support) during the conduct of the study and royalties for books on pain education and rehabilitation from NOIgroup publications and royalties for books on pain education and rehabilitation from OPTP, nonfinancial support from Reality Health for expense reimbursement for advice on pain education and rehabilitation, personal fees from ConnectHealth for UK medical advisory group membership, and being director of Pain Australia outside the submitted work; and receiving speaker or consultancy fees or reimbursement for travel and conference registration from professional societies, the international Olympic committee, professional sporting clubs and organizations, government and industry in the fields of pain education, physiotherapy, and rehabilitation. Dr McAuley reported receiving grants from the National Health and Medical Research Council of Australia (grant number 1087045 [from 2015-2020]) and receiving intervention books and online materials total of approximately AUD $3000 value from Neuro-Orthopaedic Institute of Australia during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow of Participants in a Study of the Effect of Sensorimotor Retraining on Pain Intensity in Chronic Low Back Pain
Figure 2.
Figure 2.. Outcomes in a Study of the Effect of Sensorimotor Retraining on Pain Intensity in Chronic Low Back Pain
Data presented are observed (ie, as measured) pain and disability scores during the trial period (the time from baseline to 18, 26, and 52 weeks after randomization) for the full analysis set. The middle lines within each box represent the median observed score, the squares in the boxes represent the mean observed score, the box tops and bottoms represent the IQR, the whiskers extend to the most extreme observed values within 1.5 times the IQR of the nearer quartile, and the squares beyond these points represent the observed values outside that range. More negative values indicate lower pain intensity and disability. A, The primary outcome pain intensity score using an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain imaginable); minimal clinically important difference, 1 point. B, The secondary outcome disability score using the Roland Morris Disability Questionnaire ranging from 0 (no disability) to 24 (high disability); minimal clinically important difference, 30% from baseline.

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