Chemonucleolysis or manipulation for lumbar disc herniation?
| ISRCTN | ISRCTN85788243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85788243 |
| Secondary identifying numbers | ND0020 T367 Burton R&D |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 22/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kim Burton
Scientific
Scientific
Spinal Research Unit
30 Queen Street
Huddersfield
HD1 2SP
United Kingdom
| Phone | +44 (0)1484 535200 |
|---|---|
| kim@spineresearch.org.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The purpose of this study is to compare the effects of two treatment modalities available for lumbar disc herniation. The principle aim of the project is to ascertain which, if either, treatment is superior in terms of reducing symptoms/disability, and the relative cost effectiveness/patient satisfaction. The treatments to be studied are chemonucleolysis and osteopathic manipulation. Despite the choice of a well defined low back pathology for this trial, it may be that some 'types' of patient respond better to one or other of the treatments; strenuous attempts will be made to identify any such categories. The benefits to the NHS will be the determination of the more cost-effective treatment for this condition. Should the result favour manipulation, there will be the potential for reduction both of therapeutic costs and of orthopaedic waiting lists. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lumbar disc herniation |
| Intervention | 1. Chemonucleolysis 2. Osteopathic manipulation |
| Intervention type | Other |
| Primary outcome measure | 1. Symptoms/disability and the relative cost effectiveness/patient satisfaction. 2. Pain (back and leg) and disability |
| Secondary outcome measures | Therapeutic failure |
| Overall study start date | 02/01/1994 |
| Completion date | 31/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key inclusion criteria | Patients with lumbar disc herniation |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 02/01/1994 |
| Date of final enrolment | 31/12/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Spinal Research Unit
Huddersfield
HD1 2SP
United Kingdom
HD1 2SP
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/06/2000 | Yes | No |
