Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

NCT ID: NCT04552145

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled multicenter study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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surgery

Decompression surgery

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

standard decompression surgery

physiotherapy

Physical therapy program

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type BEHAVIORAL

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

Interventions

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surgery

standard decompression surgery

Intervention Type PROCEDURE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Martina Hansen's Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Greger Lønne, md phd

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology, Fac MH, INB

Jorunn L Helbostad, phd prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology, Fac MH, INB

Locations

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Innlandet Hospital Trust

Lillehammer, , Norway

Site Status RECRUITING

Martina Hansen's Hospital

Oslo, , Norway

Site Status RECRUITING

St Olavs Hospital

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Greger Lønne, md phd

Role: CONTACT

+4797114107

Rønnaug Sulheim, pt

Role: CONTACT

Facility Contacts

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Greger Lønne, md phd

Role: primary

Elisabeth Thornes, md

Role: primary

Nikolaos Ikonomo, md

Role: backup

Sasha Gulati, md phd

Role: primary

Hege Andresen

Role: backup

Other Identifiers

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2019/283

Identifier Type: -

Identifier Source: org_study_id

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