Spinal Stenosis
Conditions
Keywords
Surgery, Physical Therapy Modalities
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.
Interventions
PROCEDUREsurgery
standard decompression surgery
BEHAVIORALPhysiotherapy
3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center.
Sponsors
St. Olavs Hospital
Sykehuset Innlandet HF
Vestre Viken Hospital Trust
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomised controlled multicenter study
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patient reported back pain by Numeric Rating Scale (NRS) | Baseline and 6 months | 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 1 year, and 2 years after index treatment | Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index |
| Patient reported leg pain by Numeric Rating Scale (NRS) | Baseline and 6 months | NRS, scores 0-10, where a higher score indicates more pain |
| Improvement of walking and standing capacity measured with accelerometer | Baseline and 6 months | 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. |
| The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI) | 1 year after index treatment | The ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability. |
| Fraction of patients crossing over from physical therapy to surgical decompression | 6 months | We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment |
Countries
Norway
Contacts
Primary ContactGreger Lønne, md phd
Backup ContactRønnaug Sulheim, pt
Outcome results
None listed