NCT04552145

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Sep 2020Aug 2027

Study Start

First participant enrolled

September 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

6 years

First QC Date

September 10, 2020

Last Update Submit

June 17, 2025

Conditions

Spinal Stenosis

Keywords

SurgeryPhysical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

  • The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)

    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 Outcomes (15)

  • Patient reported leg pain by Numeric Rating Scale (NRS)

    Baseline and 6 months

  • Patient reported leg pain by Numeric Rating Scale (NRS)

    Baseline and 1 year

  • Patient reported leg pain by Numeric Rating Scale (NRS)

    Baseline and 2 years

  • Patient reported back pain by Numeric Rating Scale (NRS)

    Baseline and 6 months

  • Patient reported back pain by Numeric Rating Scale (NRS)

    Baseline and 1 year

  • +10 more secondary outcomes

Study Arms (2)

surgery

ACTIVE COMPARATOR

Decompression surgery

Procedure: surgery

physiotherapy

ACTIVE COMPARATOR

Physical therapy program

Behavioral: Physiotherapy

Interventions

surgeryPROCEDURE

standard decompression surgery

surgery
PhysiotherapyBEHAVIORAL

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

physiotherapy

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Innlandet Hospital Trust

Lillehammer, Norway

RECRUITING

Martina Hansen's Hospital

Oslo, Norway

RECRUITING

St Olavs Hospital

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Surgical Procedures, OperativePhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Greger Lønne, md phd

    Norwegian University of Science and Technology, Fac MH, INB

    PRINCIPAL INVESTIGATOR

  • Jorunn L Helbostad, phd prof

    Norwegian University of Science and Technology, Fac MH, INB

    STUDY DIRECTOR

Central Study Contacts

Greger Lønne, md phd

CONTACT

+4797114107gloenne@me.com

Rønnaug Sulheim, pt

CONTACT

ronnaug.oleanne.sulheim@sykehuset-innlandet.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled multicenter study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 17, 2020

Study Start

September 1, 2020

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)