NCT04552145 Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
| NCT ID | NCT04552145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Norwegian University of Science and Technology |
| Condition | Spinal Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 232 participants in total. It began in 2020-09-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized controlled multicenter trail comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis. The 0-hypothesis is that there is no difference in the efficacy of structured physical therapy compared to surgical decompression. Our aim is to evaluate if physical therapy can serve as a nonsurgical alternative for patients with LSS, where the severity of symptoms indicates the need of surgical decompression.
Eligibility 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
Contact & Investigator
Greger Lønne, md phd
PRINCIPAL INVESTIGATOR
Norwegian University of Science and Technology, Fac MH, INB
Frequently Asked Questions
Who can join the NCT04552145 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04552145 currently recruiting?
Yes, NCT04552145 is actively recruiting participants. Contact the research team at gloenne@me.com for enrollment information.
Where is the NCT04552145 trial being conducted?
This trial is being conducted at Lillehammer, Norway, Oslo, Norway, Trondheim, Norway.
Who is sponsoring the NCT04552145 clinical trial?
NCT04552145 is sponsored by Norwegian University of Science and Technology. The principal investigator is Greger Lønne, md phd at Norwegian University of Science and Technology, Fac MH, INB. The trial plans to enroll 232 participants.