The RESOLVE Trial for people with chronic low back pain: protocol for a randomised clinical trial

• Published in: Journal of physiotherapy 2017-01, Vol.63 (1), p.47-48
• Main Authors: Bagg, Matthew K, Hübscher, Markus, Rabey, Martin, Wand, Benedict M, O’Hagan, Edel, Moseley, G Lorimer, Stanton, Tasha R, Maher, Chris G, Goodall, Stephen, Saing, Sopany, O’Connell, Neil E, Luomajoki, Hannu, McAuley, James H
• Format: Article
• Language: English
• Subjects: Other
• ISSN: 1836-9553; 1836-9561
• DOI: 10.1016/j.jphys.2016.11.001

Abstract Introduction Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials, achieve only modest improvements in pain, at best. Recently, treatments that target central nervous system function have been developed and tested in small studies. Combining treatments that target central nervous system function with traditional treatments directed towards functioning of the back is a promising approach that has yet to be tested in adequately powered, prospectively registered, clinical trials. The RESOLVE trial will be the first high-quality assessment of two treatment programs that combine central nervous system-directed and traditional interventions in order to improve chronic low back pain. Aim To compare the effectiveness of two treatment programs that combine central nervous system-directed and traditional interventions at reducing pain intensity at 18 weeks post randomisation in a randomised clinical trial of people with chronic low back pain. Design Two-group, randomised, clinical trial with blinding of participants and assessors. Participants and setting Two hundred and seventy-five participants with chronic low back pain that has persisted longer than 3 months and no specific spinal pathology will be recruited from the community and primary care in Sydney, Australia. Interventions Both of the interventions contain treatments that target central nervous system function combined with treatments directed towards functioning of the back. Adherence to the intervention will be monitored using an individual treatment diary and adverse events recorded through passive capture. Participants are informed prior to providing informed consent that some of the treatments are not active. Blinding is maintained by not disclosing any further information. Complete disclosure of the contents of the intervention has been made with the UNSW HREC (HC15357) and an embargoed project registration has been made on the Open Science Framework to meet the Declaration of Helsinki requirement for transparent reporting of trial methods a priori. Intervention A Participants randomised to Intervention A will receive a 12-session treatment program delivered as 60-minute sessions, scheduled approximately weekly, over a period of 12 to 18 weeks. All treatment sessions are one-on-one. The program includes a home treatment component of 30 minutes, five times