Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Procedure: surgery
* Behavioral: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery<br>Decompression surgery | Procedure: surgery<br>* standard decompression surgery<br>|
| Active Comparator: physiotherapy<br>Physical therapy program | Behavioral: Physiotherapy<br>* 3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Physical Therapy Modalities