Surgical Versus Nonsurgical Treatment for Spinal Stenosis

Spinal Stenosis Clinical Trial

Official title:

Randomized Clinical Trial of Treatment for Spinal Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022776
• Other study ID #: R01 AR45633
• Secondary ID: R01AR045622
• Status: Completed
• Phase: Phase 3
• First received: August 13, 2001
• Last updated: February 26, 2013
• Start date: September 2000
• Est. completion date: December 2007

Study information

• Verified date: February 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis

Intervention

Procedure:
• Surgical decompression
Simple decompression not requiring fusion.
• Physical therapy
2 physical therapy sessions per week for 6 weeks Followed by home program.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Outcomes Study 36-item Short Form Health Survey		Measured at Month 24	No
Secondary	Beck Depression Inventory		Measured at Month 24	No
Secondary	Oswestry Low Back Pain Disability Scale		Measured at Month 24	No
Secondary	MODEMS questionnaires		Measured at Month 24	No
Secondary	Physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill test		Measured at Month 24	No