Surgical Versus Nonsurgical Treatment for Spinal Stenosis - Full Text View

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00022776

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Randomized Clinical Trial of Treatment for Spinal Stenosis

Resource links provided by NLM:

MedlinePlus related topics: Spinal Stenosis Surgery

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Medical Outcomes Study 36-item Short Form Health Survey [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	178
Study Start Date:	September 2000
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will undergo surgery for spinal stenosis.	Procedure: Surgical decompression
2: Experimental Participants will undergo physical therapy for spinal stenosis.	Procedure: Physical therapy 2 physical therapy sessions per week for 6 weeks

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022776

Locations

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

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator:

Anthony Delitto, PhD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	University of Pittsburgh ( Anthony Delitto )
Study ID Numbers:	R01 AR45633, NIAMS-052
Study First Received:	August 13, 2001
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00022776 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Human therapy evaluation
Orthopedics
Physical therapy
Nonsurgical treatment
Surgical decompression
Surgery

Lumbar
Spine disorder
Spinal stenosis
Gender difference
Medical rehabilitation

Additional relevant MeSH terms:

Spinal Diseases
Pathological Conditions, Anatomical
Musculoskeletal Diseases

Constriction, Pathologic
Bone Diseases
Spinal Stenosis

ClinicalTrials.gov processed this record on March 18, 2010