| Source of record | UK Trials |
| ISRCTN | ISRCTN29660674 |
| Date ISRCTN assigned | 06/01/2003 |
| Local reference number(s) | M0617 |
| Public title | The use of cervical collars following anterior cervical discectomy for radiculopathy or myelopathy |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Cervical spondylosis |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
|
| Anticipated start date | 01/06/2001 |
| Anticipated end date | 31/10/2003 |
| Status of trial | Completed |
| 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 |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
United Kingdom
S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Ms E Murphy |
| Contact details | Department of Physiotherapy
Wessex Neurological Centre
Southampton General Hospital
Tremona Road
Southampton
United Kingdom
S016 6DY |
| Contact telephone | +44 (0)23 8077 7222 |
| Contact email | geoffandeve@ukgateway.net |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN29660674 |
| Date last extracted from ISRCTN register | 17/04/2008 |
