Wise Young
08-21-2001, 06:40 PM
Surgical versus Nonsurgical Treatment for Spinal Stenosis
This study is currently recruiting patients.
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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 Treatment or Intervention Phase Spinal Stenosis
Procedure:Surgical decompression
Procedure:Physical therapy
Phase III
MEDLINEplusrelated topics:SpinalStenosis
Study Type:Interventional
Study Design:Treatment,Randomized,Single Blind,Active Control,Parallel Assignment,Efficacy Study
Official Title:Randomized Clinical Trial of Treatment for Spinal Stenosis
Further Study Details:
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 above , Genders Eligible for Study: Both
Participants: Patients
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
Expected Total Enrollment: 240
Location and Contact Information
Steven George 412-383-6630 georgesz@msx.upmc.edu
Pennsylvania
University of Pittsburgh,Pittsburgh, Pennsylvania, 15261, United States;Recruiting
Steven George georgesz@msx.upmc.edu]
Study chairs or principal investigators
Anthony Delitto, Ph.D., Principal Investigator University of Pittsburgh
More Information
Study ID Numbers NIAMS-052; R01 AR45633
NLM Identifier NCT00022776
Date study startedSeptember 2000; Date Study Completed August 2004 Record last reviewed March 2001
This study is currently recruiting patients.
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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 Treatment or Intervention Phase Spinal Stenosis
Procedure:Surgical decompression
Procedure:Physical therapy
Phase III
MEDLINEplusrelated topics:SpinalStenosis
Study Type:Interventional
Study Design:Treatment,Randomized,Single Blind,Active Control,Parallel Assignment,Efficacy Study
Official Title:Randomized Clinical Trial of Treatment for Spinal Stenosis
Further Study Details:
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 above , Genders Eligible for Study: Both
Participants: Patients
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
Expected Total Enrollment: 240
Location and Contact Information
Steven George 412-383-6630 georgesz@msx.upmc.edu
Pennsylvania
University of Pittsburgh,Pittsburgh, Pennsylvania, 15261, United States;Recruiting
Steven George georgesz@msx.upmc.edu]
Study chairs or principal investigators
Anthony Delitto, Ph.D., Principal Investigator University of Pittsburgh
More Information
Study ID Numbers NIAMS-052; R01 AR45633
NLM Identifier NCT00022776
Date study startedSeptember 2000; Date Study Completed August 2004 Record last reviewed March 2001