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

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: Recruiting
• Conditions: Spinal Stenosis
• Intervention / Treatment: Procedure: surgery; Behavioral: Physiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Greger Lønne, md phd; Phone Number: +4797114107; Email: gloenne@me.com
• Study Contact Backup: Name: Rønnaug Sulheim, pt; Email: ronnaug.oleanne.sulheim@sykehuset-innlandet.no

Study Locations

• Norway
  • Lillehammer, Norway
    • Recruiting
    • Innlandet Hospital Trust
    • Contact: Greger Lønne, md phd; Email: gloenne@me.com
  • Oslo, Norway
    • Recruiting
    • Martina Hansen's Hospital
    • Contact: Elisabeth Thornes, md
    • Contact: Nikolaos Ikonomo, md
  • Trondheim, Norway
    • Recruiting
    • St Olavs Hospital
    • Contact: Hege Andresen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	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

Outcome Measure	Measure Description	Time Frame
Patient reported leg pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 6 months
Patient reported leg pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 1 year
Patient reported leg pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 2 years
Patient reported back pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 6 months
Patient reported back pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 1 year
Patient reported back pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 2 years
Walking capacity measured by six-minutes walk-test	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	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	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	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	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	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	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)	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)	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

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Sykehuset Innlandet HF; Martina Hansen's Hospital
• Investigators: 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

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): July 31, 2025

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (ACTUAL): September 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Surgery; Physical Therapy Modalities
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID 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