Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis (PTvsSD)

June 17, 2025 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Greger Lønne, md phd
  • Phone Number: +4797114107
  • Email: gloenne@me.com

Study Contact Backup

Study Locations

  • Norway
      • Lillehammer, Norway
        • Recruiting
        • Innlandet Hospital Trust
        • Contact:
      • Oslo, Norway
        • Recruiting
        • Martina Hansen's Hospital
        • Contact:
          • Elisabeth Thornes, md
        • Contact:
          • Nikolaos Ikonomo, md
      • Trondheim, Norway
        • Recruiting
        • St Olavs hospital
        • Contact:
          • Hege Andresen
        • Contact:
          • Sasha Gulati, md phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: surgery
Decompression surgery
Procedure: surgery
standard decompression surgery
Active Comparator: physiotherapy
Physical therapy program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Oswestry Disability Index 2.0 (ODI) is the most commonly used condition-specific outcome measure for spinal disorders in general. The score ranges from 0 to 100, with a lower score indicating less severe pain and disability. It has been validated into Norwegian and tested for psychometric properties.
6 months after index treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient reported leg pain by Numeric Rating Scale (NRS)
Time Frame: Baseline and 6 months
NRS, scores 0-10, where a higher score indicates more pain
Baseline and 6 months
Patient reported leg pain by Numeric Rating Scale (NRS)
Time Frame: Baseline and 1 year
NRS, scores 0-10, where a higher score indicates more pain
Baseline and 1 year
Patient reported leg pain by Numeric Rating Scale (NRS)
Time Frame: Baseline and 2 years
NRS, scores 0-10, where a higher score indicates more pain
Baseline and 2 years
Patient reported back pain by Numeric Rating Scale (NRS)
Time Frame: Baseline and 6 months
NRS, scores 0-10, where a higher score indicates more pain
Baseline and 6 months
Patient reported back pain by Numeric Rating Scale (NRS)
Time Frame: Baseline and 1 year
NRS, scores 0-10, where a higher score indicates more pain
Baseline and 1 year
Patient reported back pain by Numeric Rating Scale (NRS)
Time Frame: Baseline and 2 years
NRS, scores 0-10, where a higher score indicates more pain
Baseline and 2 years
Walking capacity measured by six-minutes walk-test
Time Frame: Baseline and 6 months
Number of patients improving by 50 m or more after six-minutes walk-test
Baseline and 6 months
Improvement in health-related quality of life
Time Frame: Baseline and 1 year, and 2 years after index treatment
Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
Baseline and 1 year, and 2 years after index treatment
Improvement in health-related quality of life
Time Frame: Baseline and 2 years
Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
Baseline and 2 years
Fraction of patients crossing over from physical therapy to surgical decompression
Time Frame: 6 months
We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment
6 months
Fraction of patients crossing over from physical therapy to surgical decompression
Time Frame: 1 year
We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment
1 year
Improvement of walking and standing capacity measured with accelerometer
Time Frame: Baseline and 6 months

We will use a body-worn tri-axial lightweight accelerometer (AX3 sensor from Axivity, York, UK) attached by a waterproof tape to the midpoint of the patients' anterior right thigh and at the lower back.

Daily physical activity such as walking, running, standing, sitting, lying down and cycling will be monitored. By comparing the continuous activity for one week before treatment, for one week at six-, and 12-month follow-up, we will be able to objectively report about changes in the activity level (25). Since LSS-patients have symptoms while walking and standing, we will report the activity as ratios of walking/standing compare to other activity, as well as summon the three longest walking/standing periods before and after treatment.
Baseline and 6 months
Improvement of walking and standing capacity measured with accelerometer
Time Frame: Baseline and 1 year

We will use a body-worn tri-axial lightweight accelerometer (AX3 sensor from Axivity, York, UK) attached by a waterproof tape to the midpoint of the patients' anterior right thigh and at the lower back.

Daily physical activity such as walking, running, standing, sitting, lying down and cycling will be monitored. By comparing the continuous activity for one week before treatment, for one week at six-, and 12-month follow-up, we will be able to objectively report about changes in the activity level (25). Since LSS-patients have symptoms while walking and standing, we will report the activity as ratios of walking/standing compare to other activity, as well as summon the three longest walking/standing periods before and after treatment.
Baseline and 1 year
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
Time Frame: 1 year after index treatment
The ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability.
1 year after index treatment
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
Time Frame: 2 years after index treatment
The ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability.
2 years after index treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Science and Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
St. Olavs Hospital
Sykehuset Innlandet HF
Martina Hansen's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Greger Lønne, md phd, Norwegian University of Science and Technology, Fac MH, INB
  • Study Director: Jorunn L Helbostad, phd prof, Norwegian University of Science and Technology, Fac MH, INB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019/283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Stenosis

Clinical Trials on surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings