ProtocolInternational Journal of Clinical Trials
Publication: Effect of biopsychosocial comprehensive chronic pain management physiotherapy practice protocol in patients with chronic musculoskeletal pain-a randomised control trial
Int J Clin Trials. 2025;12(1):50-58.DOI10.18203/2349-3259.ijct20250133
Abstract
Background Chronic musculoskeletal pain (CMP) is a common condition treated by physiotherapists. Many existing treatments focus mainly on biomedical aspects, which have limited effectiveness and do not align with clinical practice guidelines that advocate for a biopsychosocial (BPS) approach. To address this issue, a new physiotherapy protocol has been developed that incorporates pain neurophysiological education, cognitive behaviour modification, and self-management strategies. This protocol will undergo clinical trial evaluation and has the potential to transform physiotherapy practices in line with these guidelines.
Methods A randomised, single-centre clinical trial will be carried out to compare the effect of a comprehensive CMP management (CCPM) which consists of 16 sessions weekly twice for 8 weeks neuroscience education program (4 sessions, 4 hrs) cognitive behaviour modification program (6 sessions, 6 hrs), self-management strategies (4 sessions, 4 hrs) and revision of the program (2 sessions, 2 hrs) along with usual care physiotherapy treatment for thrice weekly for 8 weeks, with standardised physiotherapy thrice weekly for 8 weeks as control group. The study aims to evaluate the effect of CCPM intervention on central sensitisation, as well as on fear avoidance, pain, disability, and pain self-efficacy The outcome variables will be measured at the beginning of the intervention and after 8 weeks. Discussions: The Physiotherapy practice must adopt a multi-dimensional pathway of treatment that considers all the bio-psychosocial factors during treatment sessions, rather than just following a bio-model pathway of management. Trial registration: CTRI/2023/05/053340 [Registered on: 31/05/2023]
Keywords
Affiliations
- Department of SLM, PP Savani University, Surat, Gujarat, India
