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	Treatment or Intervention	Phase
Spinal Stenosis	Procedure: Surgical decompression  Procedure: Physical therapy	Phase III

Further Study Details: 

Primary Outcomes: Medical Outcomes Study 36-item Short Form Health Survey; Beck Depression Inventory; Oswestry Low Back Pain Disability Scale; MODEMS questionnaires; physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill test
Expected Total Enrollment:  178

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.

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Sara Piva      412-383-6712    srpst24@pitt.edu

Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15260,  United States; Recruiting

Study chairs or principal investigators

Anthony Delitto, PhD,  Principal Investigator,  University of Pittsburgh   

Study ID Numbers:  NIAMS-052; R01 AR45633
Record last reviewed:  March 2005
Last Updated:  March 23, 2005
Record first received:  August 13, 2001
ClinicalTrials.gov Identifier:  NCT00022776
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08