Clinical trial NCT04552145: Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
Official title: Physical Therapy Versus Surgical Decompression for Lumbar Spinal Stenosis: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Stenosis
Keywords: Surgery
Physical Therapy Modalities
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Sykehuset Innlandet HF
name: Martina Hansen's Hospital
First posted: 2020-09-17
Enrollment: 232
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
timeFrame: 6 months after index treatment
Secondary outcomes:
measure: Patient reported leg pain by Numeric Rating Scale (NRS)
timeFrame: Baseline and 6 months
measure: Patient reported leg pain by Numeric Rating Scale (NRS)
timeFrame: Baseline and 1 year
measure: Patient reported leg pain by Numeric Rating Scale (NRS)
timeFrame: Baseline and 2 years
measure: Patient reported back pain by Numeric Rating Scale (NRS)
timeFrame: Baseline and 6 months
measure: Patient reported back pain by Numeric Rating Scale (NRS)
timeFrame: Baseline and 1 year
measure: Patient reported back pain by Numeric Rating Scale (NRS)
timeFrame: Baseline and 2 years
measure: Walking capacity measured by six-minutes walk-test
timeFrame: Baseline and 6 months
measure: Improvement in health-related quality of life
timeFrame: Baseline and 1 year, and 2 years after index treatment
measure: Improvement in health-related quality of life
timeFrame: Baseline and 2 years
measure: Fraction of patients crossing over from physical therapy to surgical decompression
timeFrame: 6 months
measure: Fraction of patients crossing over from physical therapy to surgical decompression
timeFrame: 1 year
measure: Improvement of walking and standing capacity measured with accelerometer
timeFrame: Baseline and 6 months
measure: Improvement of walking and standing capacity measured with accelerometer
timeFrame: Baseline and 1 year
measure: The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
timeFrame: 1 year after index treatment
measure: The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
timeFrame: 2 years after index treatment
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Innlandet Hospital Trust
city: Oslo
country: Norway
facility: Martina Hansen's Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology, Fac MH, INB
name: Greger Lønne, md phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology, Fac MH, INB
name: Jorunn L Helbostad, phd prof
role: STUDY_DIRECTOR
References: