Surgery versus conservative care for lumbar disc herniation
| ISRCTN | ISRCTN50552565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50552565 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/03/2009
- Registration date
- 10/08/2009
- Last edited
- 11/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Heikki Österman
Scientific
Scientific
Tenholantie 10
Helsinki
00280
Finland
| heikki.osterman@orton.fi |
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 | Effectiveness of microdiscectomy for lumbar disc herniation: a randomised controlled trial |
| Study acronym | Iskari |
| Study objectives | Evidence on the best management of sciatica of 6 to 12 weeks' duration is limited. Surgical patients seem to have a more rapid recovery in the very short term, but the effectiveness of surgical management in mid- and long-term is unclear. |
| Ethics approval(s) | Ethical Boards of Jorvi Hospital and University Hospitals of Tampere, Kupio and Oulu approved in Autumn 1996 |
| Health condition(s) or problem(s) studied | Lumbar disc herniation |
| Intervention | Lumbar microdiscectomy versus continued non-surgical care. The non-surgical group was intended to mimic the natural course of healing of disc herniation, thus there was no specific program. The patients were encouraged to do isometric muscle exercises and walk right from the start; passive forms of treatment were discouraged. Treatment in the operative arm involved having a disc operation and a period of convalescence after that. Duration of treatment in that sense was about six weeks. Duration of treatment can be estimated at six weeks, after that the study involved observation only. Follow-up of both arms is planned to last ten years, 2- and 6-year results have been assessed (2-year results published). |
| Intervention type | Other |
| Primary outcome measure | Leg pain (Visual Analogue Scale [VAS]). Assessed 6 weeks, 3 months, 6 months, 1 year, 2 years and 6 years post randomisation. A ten-year follow-up will take place in due course. |
| Secondary outcome measures | 1. Back pain (VAS) 2. Recovery of working ability (VAS) 3. Satisfaction with treatment (VAS) 4. Disability associated with back pain (Oswestry index) 5. Self-assessed global recovery (Likert scale 0 - 6) 6. Physical findings Assessed 6 weeks, 3 months, 6 months, 1 year, 2 years and 6 years post randomisation. A ten-year follow-up will take place in due course. |
| Overall study start date | 01/01/1997 |
| Completion date | 31/12/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 56 |
| Total final enrolment | 56 |
| Key inclusion criteria | 1. Aged 20 to 50 years, either sex 2. Sciatic pain of 6 - 12 weeks' duration 3. Sciatica below knee and at least one physical finding suggestive of nerve root involvement 4. Computed tomography (CT) verified disc extrusion or sequester compatible with the clinical symptoms and findings |
| Key exclusion criteria | 1. Spontaneous resolution of sciatic symptoms during a minimum follow-up of two weeks 2. Sick leave of more than three months' duration preceding randomisation 3. Spondylolisthesis 4. Symptomatic spinal stenosis 5. Previous spine surgery 6. Pregnancy 7. Major medical or post-traumatic conditions confounding the assessment of effectiveness of treatment 8. Mental or behavioural disorder jeopardising the attachment to the trial protocol |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 31/12/1999 |
Locations
Countries of recruitment
- Finland
Study participating centre
Tenholantie 10
Helsinki
00280
Finland
00280
Finland
Sponsor information
Finnish Centre for Welfare and Health (Finland)
Government
Government
P.O. Box 30
Helsinki
00271
Finland
| info@thl.fi | |
| Website | http://www.thl.fi |
"ROR" |
https://ror.org/03tf0c761 |
Funders
Funder type
Government
Finnish Centre for Welfare and Health (Finland) - funding in the planning phase of the study
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 | 01/10/2006 | 11/07/2019 | Yes | No |
Editorial Notes
11/07/2019: Publication reference and total final enrolment added.
