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The use of cervical collars following anterior cervical discectomy for radiculopathy or myelopathy
ISRCTN ISRCTN29660674
ClinicalTrials.gov identifier
Public title The use of cervical collars following anterior cervical discectomy for radiculopathy or myelopathy
Scientific title
Acronym N/A
Serial number at source M0617
Study hypothesis Aim of the study was to determine the effect, if any, of wearing a hard collar following Anterior Cervical Discectomy (+/- Grafting) on pain, range of movement and function. No statistically or clinically significant differences were found between collar and no collar wearing groups on any outcomes, although patient compliance was a problem due to the inconvenience of wearing a collar. The need for providing patients with information and
reassurance to mitigate the need for collars is highlighted.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cervical spondylosis
Participants - inclusion criteria Patients undergoing single-level anterior cervical discectomy, with or without inter-body grafting, for either radiculopathy or myelopathy, or a combination of both, caused by predominately single-level degenerative disease. This had been confirmed by magnetic resonance imaging (MRI)
Participants - exclusion criteria 1. Under 16 years of age
2. Acute whiplash or other acute traumatic injury
3. Malignant disease or tumour
4. Concomitant disease (e.g. rheumatoid arthritis) which could influence their recovery
5. Posterior or instrumented surgery
unable to consent to the trial for any reason
Anticipated start date 01/06/2001
Anticipated end date 31/10/2003
Status of trial Completed
Patient information material
Target number of participants 51
Interventions Randomised pre-operatively to either collar-wearing or no collar-wearing group (collars to be worn continuously for 6 weeks following surgery)
Primary outcome measure(s) Neck pain and Disability Scale (NPAD)
Secondary outcome measure(s) Range of Active Cervical Flexion/Extension Movement (degrees) and Function (SF-36)
Sources of funding Arthritis Research Campaign (ARC) (UK)
Trial website
Publications
Contact name Ms  E  Murphy
  Address Department of Physiotherapy
Wessex Neurological Centre
Southampton General Hospital
Tremona Road
  City/town Southampton
  Zip/Postcode S016 6DY
  Country United Kingdom
  Tel +44 (0)23 8077 7222
  Email
Sponsor Arthritis Research Campaign (ARC) (UK)
  Address Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
  City/town Derbyshire
  Zip/Postcode S41 7TD
  Country United Kingdom
  Email info@arc.org.uk
  Sponsor website http://www.arc.org.uk
Date applied 06/01/2003
Last edited 31/07/2012
Date ISRCTN assigned 06/01/2003