Surgical Versus Nonsurgical Treatment for Spinal Stenosis

University of Pittsburgh

Status and phase: Completed; Phase 3

Conditions: Spinal Stenosis

Treatments: Procedure: Physical therapy; Procedure: Surgical decompression

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00022776

R01AR045622 (U.S. NIH Grant/Contract)

R01 AR45633

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

1

Experimental group

Description:

Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone.

Treatment:

Procedure: Surgical decompression

2

Experimental group

Description:

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.

Treatment:

Procedure: Physical therapy