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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
232
standard decompression surgery
3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center.
Innlandet Hospital Trust
Lillehammer, Norway
RECRUITINGMartina Hansen's Hospital
Oslo, Norway
RECRUITINGSt Olavs Hospital
Trondheim, Norway
RECRUITINGThe 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 treatment
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 months
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 year
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 years
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 months
Patient reported back pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Time frame: Baseline and 1 year
Patient reported back pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
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Time frame: 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
Time frame: Baseline and 6 months
Improvement in health-related quality of life
Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years after index treatment