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Recruiting NCT04552145

Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

No phase Interventional Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: surgery, Physiotherapy.
Who it may be relevant to
Registry conditions: Spinal Stenosis. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure surgery
    standard decompression surgery
  • Behavioral Physiotherapy
    3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center.

Primary outcome measures

  • The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI) [Time frame: 6 months after index treatment]
Secondary outcome measures (12)
  • Patient reported leg pain by Numeric Rating Scale (NRS) [Time frame: Baseline and 6 months]
  • Patient reported leg pain by Numeric Rating Scale (NRS) [Time frame: Baseline and 1 year]
  • Patient reported leg pain by Numeric Rating Scale (NRS) [Time frame: Baseline and 2 years]
  • Patient reported back pain by Numeric Rating Scale (NRS) [Time frame: Baseline and 6 months]
  • Patient reported back pain by Numeric Rating Scale (NRS) [Time frame: Baseline and 1 year]
  • Patient reported back pain by Numeric Rating Scale (NRS) [Time frame: Baseline and 2 years]
  • Walking capacity measured by six-minutes walk-test [Time frame: Baseline and 6 months]
  • Improvement in health-related quality of life [Time frame: Baseline and 1 year, and 2 years after index treatment]
  • Improvement in health-related quality of life [Time frame: Baseline and 2 years]
  • Fraction of patients crossing over from physical therapy to surgical decompression [Time frame: 6 months]
  • Fraction of patients crossing over from physical therapy to surgical decompression [Time frame: 1 year]
  • Improvement of walking and standing capacity measured with accelerometer [Time frame: Baseline and 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Norway · 3 centers
  • Innlandet Hospital Trust — Lillehammer
  • Martina Hansen's Hospital — Oslo
  • St Olavs Hospital — Trondheim

Identifiers

NCT: NCT04552145 · 2019/283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗