A double blind randomised controlled crossover trial of radiofrequency annuloplasty for the treatment of low back pain
| ISRCTN | ISRCTN42725861 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42725861 |
| Secondary identifying numbers | N0213112412 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/10/2016
- 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
Not provided at time of registration
Contact information
Dr Simon Dolin
Scientific
Scientific
Pain Service
St Richards Hospital
Spitalfield Lane
Chichester
PO19 4SE
United Kingdom
| Phone | +44 (0)1243 788122 |
|---|---|
| Simon.Dolin@rws-tr.nhs.uk |
Study information
| Study design | Double blind randomised controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A double blind randomised controlled crossover trial of radiofrequency annuloplasty for the treatment of low back pain |
| Study hypothesis | To evaluate clinical results of patients treated with radiofrequency annuloplasty, which is used to relieve discogenic pain in the lumbar spine |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Musculoskeletal Diseases: Low back pain |
| Intervention | Treatment group will have radiofrequency annuloplasty. Placebo group same protocol but no lesioning performed - RF generator on test mode. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2002 |
| Overall study end date | 07/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | 1. 16-70 years at first assessment 2. Moderate/severe discogenic pain 3. Oswestry disability index 20% + 4. Failed 6 months conservative treatment 5. No previous disc surgery at symptomatic levels; Body Mass Index (BMI) average or overweight range 6. Loss of disc height not >50% of normal level on Magnetic Resonance Imaging (MRI) or X-ray 7. Max two level pathology on MRI scan confirmed by discography |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/03/2002 |
| Recruitment end date | 07/03/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pain Service
Chichester
PO19 4SE
United Kingdom
PO19 4SE
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
Royal West Sussex 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 |
Editorial Notes
28/10/2016: No publications found, verifying study status with principal investigator
