The Effects of Integrating Work-related Factors and Improving Cooperation in Musculoskeletal Physical Therapy Practice: Protocol for the 'WORK TO BE DONE' Cluster Randomised Controlled Trial

Background: Musculoskeletal disorders (MSDs) are the primary cause of disability worldwide and a major societal burden. Recent qualitative research found that although a patient's work is considered important, physical therapists take work participation insufficiently into account as a determining factor in the treatment of patients with MSDs. Therefore, the aim of this study is to improve the effectiveness of physical therapy (in primary healthcare) with respect to the work participation of employees with MSDs by increasing the knowledge and skills of generalist physical therapists and by improving the collaboration between generalist physical therapists and physical therapists specialised in occupational health.

Methods/design: This trial is a two-arm non-blinded cluster randomised controlled trial. Working patients with MSDs visiting a physical therapy practice are the target group. The control group will receive normal physical therapy treatment. The intervention group will receive treatment from a physical therapist with more knowledge about work-related factors and skills in terms of integrating work participation into the patients' care. Data are gathered at baseline (T0), at four months (T1) and eight months (T2) follow-up. Most outcomes will be assessed with validated patient-reported questionnaires. Primary outcomes are the limitations in specific work-related activities and pain during work. Secondary outcomes include limitations in general work-related activities, general pain, quality of life, presenteeism, sick leave (absenteeism), estimated risk for future work disability, work-related psychosocial risk factors, job performance, and work ability. Based on a sample size calculation we need to include 221 patients in each arm (442 in total). During data analysis, each outcome variable will be analysed independently at T1 and at T2 as a dependent variable using the study group as an independent variable. In addition to the quantitative evaluation, a process evaluation will be performed by interviewing physical therapists as well as patients.

Discussion: The trial is expected to result in a more effective physical therapy process for working patients with MSDs. This will lead to a substantial reduction of costs: lower costs thanks to a more effective physical therapy process and lower costs due to less or shorter sick leave and decreased presenteeism.

Trial Registration: Netherlands Trial Register, registration number: NL8518, date of registration 9 April 2020, URL registration: https://www.trialregister.nl/trial/8518.