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Surgical Versus Nonsurgical Treatment for Spinal Stenosis
This study has been completed.
Study NCT00022776   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First Received: August 13, 2001   Last Updated: March 10, 2008   History of Changes

August 13, 2001
March 10, 2008
September 2000
December 2007   (final data collection date for primary outcome measure)
Medical Outcomes Study 36-item Short Form Health Survey [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00022776 on ClinicalTrials.gov Archive Site
  • Beck Depression Inventory [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Oswestry Low Back Pain Disability Scale [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • MODEMS questionnaires [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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
 
Surgical Versus Nonsurgical Treatment for Spinal Stenosis
Randomized Clinical Trial of Treatment for Spinal Stenosis

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.

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.

Phase III
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Spinal Stenosis
  • Procedure: Surgical decompression
  • Procedure: Physical therapy
  • Experimental: Participants will undergo surgery for spinal stenosis.
  • Experimental: Participants will undergo physical therapy for spinal stenosis.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
178
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022776
Anthony Delitto, University of Pittsburgh
R01 AR45633, NIAMS-052
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 
Principal Investigator: Anthony Delitto, PhD University of Pittsburgh
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP