(Cost-)Effectiveness of personalised multimodal physiotherapy compared to surgery in patients with painful cervical radiculopathy. Protocol for a randomised non-inferiority trial (The MOVE-IT study).

BACKGROUND

Painful cervical radiculopathy can lead to substantial and long-lasting limitations in activities and participation. Surgery is considered when conservative treatment fails to deliver relevant improvements or when neurological signs are severe. However, personalised multimodal physiotherapy may offer non-inferior outcomes to surgery, with possibly fewer adverse events and lower costs. Further research is needed to assess the (cost-)effectiveness of personalised multimodal physiotherapy compared to surgery.

METHODS

This randomised non-inferiority study compares personalised multimodal physiotherapy to anterior cervical discectomy with fusion (1:1 allocation ratio) among 126 patients with painful cervical radiculopathy having an indication for surgery, recruited by neurologists. Personalised multimodal physiotherapy uses a mechanism-based approach within a biopsychosocial framework and is tailored to the individual patient. The primary outcome is disability over 12 months using the neck disability index with a prespecified non-inferiority margin of three points. Secondary outcomes include arm and neck pain, fear of movement, and complications. Outcomes are measured at baseline and at three, six, nine, and 12 month follow-up. Additionally, a process evaluation and cost-effectiveness analysis will be performed. Data will be analysed according to the 'intention-to-treat' and the 'per-protocol' principle. Both will be conducted using linear and logistic mixed models.

ETHICS AND DISSEMINATION: The study is approved by the medical ethics committee Brabant (P2327).

STUDY REGISTRATION NUMBER AND STATUS: The study protocol is registered at Open Science Framework (ID:S7HWA; registered June 27th, 2023). Recruitment commenced in May 2024. All data are anticipated to be collected by July 2027 when data analysis and interpretation will commence.