Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
ConditionSpinal Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorNorwegian University of Science and Technology
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Vascular intermittent claudication
Lumbar spinal stenosis in more than two levels
Previous low back surgery
Symptomatic lumbar disc herniation
Trial design
Design model
Parallel
Treatments tested in this trial
surgery
Procedure/Surgerystandard decompression surgery
Physiotherapy
Behavioral3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center.
Treatment groups
232 Participants
are divided into 2 treatment groupsGroup A: surgeryActive comparator 1 intervention
Group B: physiotherapyActive comparator 1 intervention
Trial outcomes
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.
Time frame
6 months after index treatmentSecondary outcomes
1
Patient reported leg pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Time frame
Baseline and 6 months2
Patient reported leg pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Time frame
Baseline and 1 year3
Patient reported leg pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Time frame
Baseline and 2 years4
Patient reported back pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Time frame
Baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian University of Science and Technology
Lead sponsor
St. Olavs Hospital
Collaborator
Sykehuset Innlandet HF
Collaborator
Vestre Viken Hospital Trust
Collaborator
Source ClinicalTrials.gov