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

ISRCTN ISRCTN29660674
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

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

Phone +44 (0)23 8077 7222

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeOther
Scientific title
Study objectivesAim 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) studiedCervical spondylosis
InterventionRandomised pre-operatively to either collar-wearing or no collar-wearing group (collars to be worn continuously for 6 weeks following surgery)
Intervention typeProcedure/Surgery
Primary outcome measureNeck pain and Disability Scale (NPAD)
Secondary outcome measuresRange of Active Cervical Flexion/Extension Movement (degrees) and Function (SF-36)
Overall study start date01/06/2001
Completion date31/10/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants51
Key inclusion criteriaPatients 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 criteria1. 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 enrolment01/06/2001
Date of final enrolment31/10/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Physiotherapy
Southampton
S016 6DY
United Kingdom

Sponsor information

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Email info@arc.org.uk
Website http://www.arc.org.uk
ROR logo "ROR" https://ror.org/02jkpm469

Funders

Funder type

Charity

Arthritis Research Campaign (ARC) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan