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 |
| Protocol serial number | N0213112412 |
| Sponsor | Department of Health (UK) |
| Funder | Royal West Sussex Trust (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A double blind randomised controlled crossover trial of radiofrequency annuloplasty for the treatment of low back pain |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 07/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 07/03/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Pain Service
Chichester
PO19 4SE
United Kingdom
PO19 4SE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
28/10/2016: No publications found, verifying study status with principal investigator
