Comparing physical therapy and surgery for lumbar spinal stenosis
Physical Therapy Versus Surgical Decompression for Lumbar Spinal Stenosis: A Multicenter Randomized Controlled Trial
This study is testing whether physical therapy can help people with lumbar spinal stenosis just as well as surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Norwegian University of Science and Technology Academic / other |
| Locations | 3 sites (Lillehammer and 2 other locations) |
| Trial ID | NCT04552145 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled multicenter trial that compares the effectiveness of structured physical therapy against surgical decompression in patients suffering from lumbar spinal stenosis. The study aims to determine whether physical therapy can be a viable nonsurgical alternative for patients whose symptoms suggest the need for surgical intervention. Participants will be evaluated based on their symptoms, MRI findings, and overall fitness for physical exercise. The trial will help clarify the efficacy of non-invasive treatment options for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients experiencing intermittent neurogenic claudication with MRI-confirmed lumbar spinal stenosis for over six months who are candidates for surgical treatment.
Not a fit: Patients with more than two levels of lumbar spinal stenosis, previous low back surgery, or severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a non-surgical treatment option for lumbar spinal stenosis, potentially reducing the need for surgery.
How similar studies have performed: Other studies have explored similar comparisons between physical therapy and surgical options, indicating potential for success, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients describing intermittent neurogenic claudication when walking and symptoms revealed by flexion of the spine. * MRI shows lumbar spinal stenosis in one or two levels measured. * The duration of the symptoms is longer than six months * The patient is a candidate for surgical treatment * The patient is capable of physical exercise Exclusion Criteria: * Vascular intermittent claudication * Lumbar spinal stenosis in more than two levels * Previous low back surgery * Symptomatic lumbar disc herniation * Degenerative scoliosis with Cobbs angle 30 degrees or more * Degenerative spondylolisthesis grade 2 or more * Spondylolysis with spondylolisthesis * Recent osteoporotic fractures in the spine (last 6 month) * Severe symptomatic arthrosis in hip or knee * Locally advanced or metastatic cancer * ASA \>3 * Polyneuropathy recognized by neurography * Insufficient Norwegian language skills
Where this trial is running
Lillehammer and 2 other locations
- Innlandet Hospital Trust — Lillehammer, Norway (Recruiting)
- Martina Hansen's Hospital — Oslo, Norway (Recruiting)
- St Olavs Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Greger Lønne, md phd — Norwegian University of Science and Technology, Fac MH, INB
- Study coordinator: Greger Lønne, md phd
- Email: gloenne@me.com
- Phone: +4797114107
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.