Evaluation of an external device reflecting infra-red body heat loss to the neck area for chronic mechanical neck pain: a randomised, double-blind controlled trial
| ISRCTN | ISRCTN73585687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73585687 |
| Secondary identifying numbers | N0263115136 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Mr J Lafuente
Scientific
Scientific
Department of Neurosurgery
National Hospital for Neurology & Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
| Phone | +44 020 7837 3611 |
|---|
Study information
| Study design | Randomised, double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Can the infra-red reflective device reduce neck pain and disability advantageously in patients suffering from chronic mechanical neck pain as compared with a placebo device? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Neck pain |
| Intervention | 1. Real neck device 2. Dummy device |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Pain visual analogue scale, neck disability index and general health status (SF36). |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 14/05/2002 |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 60 patients from Neurosurgery/NSITU. |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 14/05/2002 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Neurosurgery
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University College London Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
