Face-to-face physiotherapy compared to a supported home exercise program for the management of musculoskeletal conditions: Protocol of a multicentre, randomised controlled trial: the REFORM trial

Hannah G. Withers, Joanne V. Glinsky, Jackie Chu, Matthew D. Jennings, Alison J. Hayes, Ian J. Starkey, Blake A. Palmer, Lukas Szymanek, Jackson J. Cruwys, David Wong, Kitty Duong, Anne Barnett, Matthew J. Tindall, Barbara R. Lucas, Tara E. Lambert, Catherine Sherrington, Christopher G. Maher, Manuela L. Ferreira, Deborah A. Taylor, Lisa A. Harvey

Background: Exercise, support and advice are considered core components of management for most musculoskeletal conditions and are typically provided by physiotherapists through regular face-to-face treatments. However, exercise can be provided remotely as part of a home exercise program while support and advice can be provided over the telephone. There is initial evidence from trials and systematic reviews to suggest that remotely-provided physiotherapy can be used to manage a variety of musculoskeletal conditions safely and effectively.

Aims: The aim of this single-blind randomised controlled non-inferiority trial is to determine whether a supported home exercise programme is as good as or better than face-to-face physiotherapy for the treatment of musculoskeletal conditions. A Process Evaluation will be completed alongside the primary trial.

Methods: 210 participants will be recruited from four public hospitals in Sydney, Australia. Participants will be randomised to either the Supported Home Exercise Group or the Face-to-face Physiotherapy group. Participants allocated to the Supported Home Exercise Group will initially receive one face-to-face session with the trial physiotherapist and will then be managed remotely for the next 6 weeks. Participants allocated to the Face-to-face Physiotherapy Group will receive a course of physiotherapy as typically provided in Sydney government hospitals. The primary outcome is function measured by the Patient Specific Functional Scale at 6 weeks. There will be 9 secondary outcomes measured at 6 and 26 weeks. Separate analyses will be conducted on each outcome and all analyses will be conducted on an intention-to-treat basis. Two frameworks (REAIM and realist), will be broadly used to guide a process evaluation using a mixed methods approach.

Results: It is anticipated that the trial will be completed by Jun 2022 (Delayed due to COVID). Results from the semi structured interview component of the Process Evaluation demonstrate that the underlying assumptions around the intervention have been upheld.

Conclusion: This trial will investigate two different models of physiotherapy care for people with musculoskeletal conditions.