Surgical Versus Nonsurgical Treatment for Spinal Stenosis

Phase 3

Completed

• Conditions: Spinal Stenosis
• Interventions: Procedure: Surgical decompression; Procedure: Physical therapy

• Registration Number: NCT00022776
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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 Timeline

• Study Start: 2000-09
• Study First Submitted: 2001-08-13
• Study First Submitted QC: 2001-08-14
• Study First Posted: 2001-08-15
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Surgical decompression	Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone.
2	Physical therapy	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.

Primary Outcome Measures

Name	Time	Method
Medical Outcomes Study 36-item Short Form Health Survey	Measured at Month 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States