The use of cervical collars following anterior cervical discectomy for radiculopathy or myelopathy
ISRCTN | ISRCTN29660674 |
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DOI | https://doi.org/10.1186/ISRCTN29660674 |
Secondary identifying numbers | M0617 |
- Submission date
- 06/01/2003
- Registration date
- 06/01/2003
- Last edited
- 31/07/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms E Murphy
Scientific
Scientific
Department of Physiotherapy
Wessex Neurological Centre
Southampton General Hospital
Tremona Road
Southampton
S016 6DY
United Kingdom
Phone | +44 (0)23 8077 7222 |
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Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Other |
Scientific title | |
Study objectives | 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. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Cervical spondylosis |
Intervention | Randomised pre-operatively to either collar-wearing or no collar-wearing group (collars to be worn continuously for 6 weeks following surgery) |
Intervention type | Procedure/Surgery |
Primary outcome measure | Neck pain and Disability Scale (NPAD) |
Secondary outcome measures | Range of Active Cervical Flexion/Extension Movement (degrees) and Function (SF-36) |
Overall study start date | 01/06/2001 |
Completion date | 31/10/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 51 |
Key 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) |
Key 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 |
Date of first enrolment | 01/06/2001 |
Date of final enrolment | 31/10/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Physiotherapy
Southampton
S016 6DY
United Kingdom
S016 6DY
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
info@arc.org.uk | |
Website | http://www.arc.org.uk |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (ARC) (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |