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Surgical Versus Nonsurgical Treatment for Spinal Stenosis

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00022776
First received: August 13, 2001
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

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 ]
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
Experimental: 1
Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone.
 Procedure: Surgical decompression
Simple decompression not requiring fusion.
Other Names:
  • Laminectomy
  • Foraminotomy
Experimental: 2
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.
 Procedure: Physical therapy
2 physical therapy sessions per week for 6 weeks Followed by home program.
Other Names:
  • Exercises
  • Aerobics
  • Strengthening

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Pittsburgh
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
ClinicalTrials.gov Identifier: NCT00022776     History of Changes
Other Study ID Numbers: R01 AR45633, R01AR045622
Study First Received: August 13, 2001
Last Updated: February 26, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
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 Stenosis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on March 03, 2015