Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
M0617
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Neck pain and Disability Scale (NPAD)
Secondary outcome measures
Range of Active Cervical Flexion/Extension Movement (degrees) and Function (SF-36)
Overall trial start date
01/06/2001
Overall trial end date
31/10/2003
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
51
Participant 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
Recruitment start date
01/06/2001
Recruitment end date
31/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Physiotherapy
Southampton
S016 6DY
United Kingdom
Sponsor information
Organisation
Arthritis Research Campaign (ARC) (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (ARC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary