Posture control after lumbar microdiscectomy
| ISRCTN | ISRCTN14206374 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14206374 |
| Secondary identifying numbers | S50782 |
- Submission date
- 17/02/2008
- Registration date
- 10/03/2008
- Last edited
- 10/03/2008
- 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
Prof Bart Depreitere
Scientific
Scientific
Department of Neurosurgery
University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium
Study information
| Study design | Interventional, randomised, single centre trial with four arms (two variables: early specific physio versus later non-specific physio; transmuscular versus paramedian surgical approach). |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (in Dutch). |
| Scientific title | Posture control after lumbar microdiscectomy: effect of transmuscular surgical approach and of early postoperative physiotherapy - a randomised clinical trial |
| Study objectives | 1. Transmuscular surgical approach causes less damage to postoperative posture control because it does not damage the back muscle insertions 2. Early postoperative physiotherapy improves short and long term posture control |
| Ethics approval(s) | Ethics approval received from the Commissie Medische Ethiek of Leuven University Hospitals in November 2007. |
| Health condition(s) or problem(s) studied | Sciatica caused by a lumbar disc herniation |
| Intervention | 1. Transmuscular surgical approach versus classic paramedian approach to the disc herniation at surgery 2. Early postoperative physiotherapy, starting two weeks postoperatively, and consisting of an individualised program with standardised goals versus 'conservative' treatment: no physiotherapy in the first six weeks post-operation and after six weeks only when indicated Follow up is one year for all four arms. |
| Intervention type | Other |
| Primary outcome measure | Muscle control (assessed by postural balance test and sit-to-stand test), assessed in the lab at two weeks, eight weeks and six months post-operatively. |
| Secondary outcome measures | Comfort: 1. Back pain 2. Sciatica 3. Functional status 4. Return to work Secondary outcome measures are assessed by standardised patient questionnaires preoperatively and at two weeks, eight weeks, six months and one year postoperatively. |
| Overall study start date | 18/02/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. One level disc herniation, either L4-L5 or L5-S1, explaining symptoms and representing operative indication. Purely median disc herniations are excluded. 2. Age: 18 - 60 years, either sex 3. Living within 30 km perimeter of the hospital 4. Informed consent signed |
| Key exclusion criteria | 1. Emergency operation required 2. Litigation, worker's compensation 3. Clinical suspicion of depression or fibromyalgia (the suffering is not exlusively explained by the disc herniation) 4. Previous lumbar surgery, irrespective of the level 5. Significant neurological deficit (weakness worse than 4/5) 6. Systemic disease significantly affecting patient's functioning (American Society of Anaesthesiologists [ASA] grade greater than 3) 7. Median disc herniation 8. Patient unable to communicate in the Dutch language |
| Date of first enrolment | 18/02/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Department of Neurosurgery
Leuven
3000
Belgium
3000
Belgium
Sponsor information
University Hospitals Leuven (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Herestraat 49
Leuven
3000
Belgium
| Website | http://www.uzleuven.be/ |
|---|---|
"ROR" |
https://ror.org/0424bsv16 |
Funders
Funder type
Industry
Contribution for logistic expenses:
No information available
Medtronic B.V. (The Netherlands)
No information available
Stryker Nederland (The Netherlands)
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 |
