Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

Spinal Stenosis Clinical Trial

— PTvsSD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04552145
• Other study ID #: 2019/283
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: September 2022
• Source: Norwegian University of Science and Technology
• Contact: Greger Lønne, md phd
• Phone: +4797114107
• Email: gloenne[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis

Intervention

Procedure:
• surgery
standard decompression surgery

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.

Locations

Country	Name	City	State
Norway	Innlandet Hospital Trust	Lillehammer
Norway	Martina Hansen's Hospital	Oslo
Norway	St Olavs Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Martina Hansen's Hospital, St. Olavs Hospital, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient reported leg pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 6 months
Secondary	Patient reported leg pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 1 year
Secondary	Patient reported leg pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 2 years
Secondary	Patient reported back pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 6 months
Secondary	Patient reported back pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 1 year
Secondary	Patient reported back pain by Numeric Rating Scale (NRS)	NRS, scores 0-10, where a higher score indicates more pain	Baseline and 2 years
Secondary	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
Secondary	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
Secondary	Improvement in health-related quality of life	Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index	Baseline and 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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