ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgical Versus Nonsurgical Treatment for Spinal Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00022776
Recruitment Status : Completed
First Posted : August 15, 2001
Last Update Posted : February 27, 2013
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Pittsburgh

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Spinal Stenosis Procedure: Surgical decompression Procedure: Physical therapy Phase 3

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Treatment for Spinal Stenosis
Study Start Date : September 2000
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Medical Outcomes Study 36-item Short Form Health Survey [ Time Frame: Measured at Month 24 ]

Secondary Outcome Measures :
  1. Beck Depression Inventory [ Time Frame: Measured at Month 24 ]
  2. Oswestry Low Back Pain Disability Scale [ Time Frame: Measured at Month 24 ]
  3. MODEMS questionnaires [ Time Frame: Measured at Month 24 ]
  4. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00022776     History of Changes
Other Study ID Numbers: R01 AR45633
R01AR045622 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2001    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013

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:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases