A randomised controlled trial comparing gradual vs. immediate removal or orthosis following clinical union of traumatic cervical spinal injuries in relation to activity limitation and participation restriction measures.

Title: A trial of gradual compared with immediate removal of orthosis in patients with cervical spinal injury Background information: It is not known whether gradual removal of an orthosis or immediately removal is more superior when the doctor says it is safe for the orthosis to come off Objectives: To investigate the effect of gradual compared with immediate removal of orthosis on functional outcome, pain, use of opioid analgesia, ability and confidence to return to work in patients who sustained cervical spine trauma treated either conservatively or by surgery. Participants: 85 patients aged 18 years or more with cervical spine trauma were recruited at time of clinical union. Interventions: Randomisation to gradual or immediate removal of orthosis at time of clinical union. Main outcome measures: Outcomes were assessed on day of clinical union, and 2 and 6 weeks after this point. The primary outcome measure was the Neck Disability Index. Other measures included an 11-point Numerical Pain Rating Scale (NPRS), use of opioid analgesia, the short form 12-item survey questionnaire (SF-12), and the Fear Avoidance Belief (FAB) questionnaire. Results: There were no differences between the groups in any of the outcome measures. Both groups showed improvements in all outcome measures at all time points.