Condition category
Surgery
Date applied
06/01/2003
Date assigned
06/01/2003
Last edited
31/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms E Murphy

ORCID ID

Contact details

Department of Physiotherapy
Wessex Neurological Centre
Southampton General Hospital
Tremona Road
Southampton
S016 6DY
United Kingdom
+44 (0)23 8077 7222

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

http://www.arc.org.uk

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

Publication citations

Additional files

Editorial Notes