Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

Not Applicable

Recruiting

• Conditions: Spinal Stenosis
• Interventions: Procedure: surgery; Behavioral: Physiotherapy

• Registration Number: NCT04552145
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19
• Primary Completion: 2022-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 232

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery	surgery	Decompression surgery
physiotherapy	Physiotherapy	Physical therapy program

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient reported back pain by Numeric Rating Scale (NRS)	Baseline and 2 years	NRS, scores 0-10, where a higher score indicates more pain
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)	2 years after index treatment	The ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability.
Patient reported leg pain by Numeric Rating Scale (NRS)	Baseline and 2 years	NRS, scores 0-10, where a higher score indicates more pain
Walking capacity measured by six-minutes walk-test	Baseline and 6 months	Number of patients improving by 50 m or more after six-minutes walk-test
Improvement in health-related quality of life	Baseline and 2 years	Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
Improvement of walking and standing capacity measured with accelerometer	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.
Fraction of patients crossing over from physical therapy to surgical decompression	1 year	We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment

Trial Locations

Locations (3)

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Martina Hansen's Hospital; 🇳🇴 Oslo, Norway

Innlandet Hospital Trust; 🇳🇴 Lillehammer, Norway