Surgical Versus Nonsurgical Treatment for Spinal Stenosis
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|ClinicalTrials.gov Identifier: NCT00022776|
Recruitment Status : Completed
First Posted : August 15, 2001
Last Update Posted : February 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Stenosis||Procedure: Surgical decompression Procedure: Physical therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||178 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial of Treatment for Spinal Stenosis|
|Study Start Date :||September 2000|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone.
Procedure: Surgical decompression
Simple decompression not requiring fusion.
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
2 physical therapy sessions per week for 6 weeks Followed by home program.
- Medical Outcomes Study 36-item Short Form Health Survey [ Time Frame: Measured at Month 24 ]
- Beck Depression Inventory [ Time Frame: Measured at Month 24 ]
- Oswestry Low Back Pain Disability Scale [ Time Frame: Measured at Month 24 ]
- MODEMS questionnaires [ Time Frame: Measured at Month 24 ]
- Physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill test [ Time Frame: Measured at Month 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022776
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15260|
|Principal Investigator:||Anthony Delitto, PhD||University of Pittsburgh|