ReMiDY (rehabilitation in mild stable degenerative cervical myelopathy): protocol for feasibility randomized controlled trial

Abstract Study design A two parallel group exploratory single center feasibility randomised controlled trial. A nested qualitative study will explore the acceptability of the study processes and patient and physiotherapists experiences of the interventions. Objectives The aim of this trial is to test the feasibility of undertaking an RCT investigating the effectiveness of a mult- component structured physical rehabilitation intervention aimed at reducing physical disability in adults with mild stable DCM compared with clinical surveillance. Setting The study will take place in the national neurosurgical centre in Dublin, Ireland. Methods A two parallel group exploratory single center feasibility RCT with will recruit 24 people with mild stable DCM from the outpatient clinics of a tertiary neurosurgical referral service. A nested qualitative study will explore the acceptability of the study processes and patient and physiotherapist experiences of the interventions. The intervention will include education, a physical activity behavioural change intervention, cervical range of motion exercises, neck, upper limb and scapular strengthening exercises and task specific hand function training. The primary outcomes are the feasibility of recruitment, adherence, and retention. The secondary outcomes which will be completed at baseline and 12 weeks follow up are the DCM core outcome set and an NRS for neck and arm pain. Conclusion Developing novel rehabilitation interventions for people with DCM is the sixth most important research priority in the field of DCM. The findings from this feasibility RCT will inform the feasibility and design of a future definitive RCT. Sponsorship Caroline Treanor is undertaking a professional doctorate for which she has received financial support from the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) programme.