A randomised controlled trial comparing gradual vs. immediate removal of orthosis following clinical union of traumatic cervical spinal injuries

Not Applicable

Completed

• Conditions: cervical spinal trauma including fractures and ligamentous injuries; Injuries and Accidents - Fractures; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12612000230853
• Lead Sponsor: Alfred Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-23
• Study Completion: 2015-03-01
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

males and females at 18 years of age and over with cervical spinal trauma who are immobilised in an orthosis
-ability to read and write English
-eligible participants shall be deemed healthy

Exclusion Criteria

-age and English barrier as outlined above
-multitrauma shall be excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eck Disability Index (NDI)[-at baseline (at time of clinical union), at 2 weeks following clinical union and 6 weeks following clinical union]

Secondary Outcome Measures

Name	Time	Method
-11 point Numerical Pain Rating Scale ((NPRS)[-daily diary recording up to 6 weeks following clinical union];-use of opioid analgesia[-daily diary recording up to 6 weeks following clinical union];-the Short Form 12-item survey questionnaire(SF-12)[-at baseline,2 weeks and 6 weeks following clinical union];-The Fear Avoidance Beliefs (FAB) Questionnaire[-at baseline, 2 weeks and 6 weeks following clinical union]