Surgical Versus Nonsurgical Treatment for Spinal Stenosis

Study Overview
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Brief Summary
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Lumbar spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) is a condition that occurs frequently, particularly in the elderly. This condition can lead to significant pain and limit a person's ability to function. Moreover, doctors disagree about the best way to treat people with lumbar spinal stenosis. In this study we will compare surgical treatment of lumbar spinal stenosis with nonsurgical treatment using physical therapy. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.

Detailed Description
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Lumbar spinal stenosis is a frequently encountered condition, particularly in the elderly, which can lead to significant pain and functional limitations. The prevalence of this condition is growing as the population continues to age. Substantial controversy exists regarding the management of lumbar spinal stenosis. Surgery has traditionally been the treatment of choice, although physicians typically recommend a trial of nonsurgical care prior to surgery. The most effective means of nonsurgical treatment has not been identified, although a standard regimen has been developed. There is presently no evidence in the literature regarding the relative effectiveness of surgical versus nonsurgical treatment of lumbar spinal stenosis, or the efficacy of the standard nonsurgical treatment approach. This randomized clinical trial will compare surgical decompression versus nonsurgical treatment (i.e., physical therapy) of lumbar spinal stenosis. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.

Official Title
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Randomized Clinical Trial of Treatment for Spinal Stenosis

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Procedure: Surgical decompression
* Procedure: Physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Imaging evidence of stenosis Unable to walk more than 1/4 of a mile No prior surgery for stenosis Consents to surgery Speaks English Exclusion Criteria: Presence of dementia or organic brain syndrome Coronary artery disease, recent myocardial infarction, pulmonary or vascular disease Spondylolisthesis (> 5 mm slippage) Severe osteoporosis Metastatic cancer

Ages Eligible for Study
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Minimum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone. | Procedure: Surgical decompression<br>* Simple decompression not requiring fusion.<br>* Other names: Foraminotomy;|
| Experimental: 2<br>Participants will undergo physical therapy for spinal stenosis. These participants will undergo a physical therapy program emphasizing lumbar flexion exercises, general conditioning exercises, and patient education for six weeks, with a frequency of 1-2 visits per week. Each patient will receive instruction in a home exercise program. | Procedure: Physical therapy<br>* 2 physical therapy sessions per week for 6 weeks Followed by home program.<br>* Other names: Strengthening;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcomes Study 36-item Short Form Health Survey |  | Measured at Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  | Measured at Month 24 | 
| Oswestry Low Back Pain Disability Scale |  | Measured at Month 24 | 
| MODEMS questionnaires |  | Measured at Month 24 | 
| Physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill test |  | Measured at Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human therapy evaluation, Orthopedics, Physical therapy, Nonsurgical treatment, Surgical decompression, Surgery, Lumbar, Spine disorder, Spinal stenosis, Gender difference, Medical rehabilitation