RecruitingNot ApplicableNCT04552145

Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

Physical Therapy Versus Surgical Decompression for Lumbar Spinal Stenosis: A Multicenter Randomized Controlled Trial


Sponsor

Norwegian University of Science and Technology

Enrollment

232 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria13

  • 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

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Interventions

PROCEDUREsurgery

standard decompression surgery

BEHAVIORALPhysiotherapy

3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center.


Locations(3)

Innlandet Hospital Trust

Lillehammer, Norway

Martina Hansen's Hospital

Oslo, Norway

St Olavs Hospital

Trondheim, Norway

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NCT04552145


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