Matthew K Bagg1,2,3, Benedict M Wand4, Aidan G Cashin1,5, Hopin Lee6,7, Markus Hübscher1, Tasha R Stanton8, Neil E O'Connell9, Edel T O'Hagan1,10, Rodrigo R N Rizzo1,5, Michael A Wewege1,5, Martin Rabey1, Stephen Goodall11, Sopany Saing11, Serigne N Lo12,13, Hannu Luomajoki14, Robert D Herbert15, Chris G Maher16,17, G Lorimer Moseley8, James H McAuley1,5. 1. Centre for Pain IMPACT (Investigating Mechanisms of Pain to Advance Clinical Translation), Neuroscience Research Australia, Sydney, Australia. 2. Curtin Health Innovation Research Institute, Faculty of Health Sciences, Curtin University, Perth, Australia. 3. Perron Institute for Neurological and Translational Science, Perth, Australia. 4. Faculty of Medicine, Nursing and Midwifery and Health Sciences, The University of Notre Dame Australia, Fremantle, Australia. 5. School of Health Sciences, University of New South Wales, Sydney, Australia. 6. Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom. 7. School of Medicine and Public Health, University of Newcastle, Newcastle, Australia. 8. IIMPACT (Innovation, IMPlementation And Clinical Translation) in Health, University of South Australia, Kaurna Country, Adelaide, Australia. 9. Department of Health Sciences, Centre for Health and Wellbeing Across the Lifecourse, Brunel University London, Uxbridge, United Kingdom. 10. Prince of Wales Clinical School, University of New South Wales, Sydney, Australia. 11. Centre for Health Economics Research and Evaluation, Faculty of Health, University of Technology Sydney, Sydney, Australia. 12. Melanoma Institute Australia, University of Sydney, Sydney, Australia. 13. Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. 14. School of Health Professions, Zurich University of Applied Sciences, Institute of Physiotherapy, Winterthur, Switzerland. 15. Neuroscience Research Australia, Sydney, Australia. 16. Sydney School of Public Health, The University of Sydney, Sydney, Australia. 17. Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, Australia.
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.
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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