The use of cervical collars following anterior cervical discectomy for radiculopathy or myelopathy

ISRCTN	ISRCTN29660674
DOI	https://doi.org/10.1186/ISRCTN29660674
Protocol serial number	M0617
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (ARC) (UK)

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

Ms E Murphy
Scientific

Department of Physiotherapy
Wessex Neurological Centre
Southampton General Hospital
Tremona Road
Southampton
S016 6DY
United Kingdom

Phone	+44 (0)23 8077 7222

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Neck pain and Disability Scale (NPAD)
Key secondary outcome measure(s)	Range of Active Cervical Flexion/Extension Movement (degrees) and Function (SF-36)
Completion date	31/10/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Department of Physiotherapy

Southampton
S016 6DY
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan