Comparing post-surgery treatment for lumbar spinal stenosis
Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis
NA · SRH Gesundheitszentrum Bad Herrenalb · NCT05312281
This study tests if wearing a back brace for six weeks after surgery can help people with lumbar spinal stenosis recover faster by reducing pain and improving their ability to walk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | SRH Gesundheitszentrum Bad Herrenalb (network) |
| Locations | 1 site (Karlsruhe) |
| Trial ID | NCT05312281 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of wearing a lumbar orthosis for six weeks following surgical decompression for lumbar spinal stenosis. It aims to determine if this post-operative immobilization can reduce the rate of early recurrence, increase walking distance, and decrease pain and pain medication usage more rapidly after surgery. The study addresses a gap in high-quality evidence regarding the use of orthoses in postoperative care for spinal stenosis patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-80 who are undergoing decompression surgery for lumbar spinal stenosis and can walk at least 100 meters pre-operatively.
Not a fit: Patients who have undergone fusion surgery, have spinal tumors, or suffer from autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery outcomes and quality of life for patients undergoing surgery for lumbar spinal stenosis.
How similar studies have performed: Previous studies have shown some advantages of using lumbar orthoses in conservative therapy for spinal conditions, but high-quality studies on postoperative use are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Decompression with hemi-/ partial laminectomy, one. Laminectomy, and foraminotomy. Flavectomy with undercutting due to uni-and multi-segmental spinal stenosis. * Age 20-80 years * Pre-operative walking distance at least 100m * Consent form signed by the patient Exclusion Criteria: * Fusion surgery or recurrent surgery * Tumors of the spine * Cervical spinal stenosis or myelopathy * Rheumatoid arthritis or similar autoimmune disease * Infection - request for a pension * Dyspnea due to heart failure with limited walking distance * Peripheral Arterial Occlusive Disease (PAOD)-
Where this trial is running
Karlsruhe
- Klinikum Karlsruhe — Karlsruhe, Germany (RECRUITING)
Study contacts
- Study coordinator: Uwe Spetzger, Prof
- Email: uwe.spetzger@klinikum-karlsruhe.de
- Phone: +497219740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Stenosis