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Surgical Versus Nonsurgical Treatment for Spinal Stenosis
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Spinal Stenosis | Procedure: Surgical decompression Procedure: Physical therapy | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Trial of Treatment for Spinal Stenosis |
- 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 ]
| Enrollment: | 178 |
| Study Start Date: | September 2000 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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Experimental: 1
Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone.
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Procedure: Surgical decompression
Simple decompression not requiring fusion.
Other Names:
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Experimental: 2
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.
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Procedure: Physical therapy
2 physical therapy sessions per week for 6 weeks Followed by home program.
Other Names:
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00022776
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15260 | |
| Principal Investigator: | Anthony Delitto, PhD | University of Pittsburgh |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00022776 History of Changes |
| Other Study ID Numbers: |
R01 AR45633 R01AR045622 ( U.S. NIH Grant/Contract ) |
| Study First Received: | August 13, 2001 |
| Last Updated: | February 26, 2013 |
Keywords provided by University of Pittsburgh:
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Human therapy evaluation Orthopedics Physical therapy Nonsurgical treatment Surgical decompression Surgery |
Lumbar Spine disorder Spinal stenosis Gender difference Medical rehabilitation |
Additional relevant MeSH terms:
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Constriction, Pathologic Spinal Stenosis Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on August 21, 2017