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Surgical Versus Nonsurgical Treatment for Spinal Stenosis

Primary Purpose

Spinal Stenosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Surgical decompression
Physical therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis focused on measuring Human therapy evaluation, Orthopedics, Physical therapy, Nonsurgical treatment, Surgical decompression, Surgery, Lumbar, Spine disorder, Spinal stenosis, Gender difference, Medical rehabilitation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone.

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.

Outcomes

Primary Outcome Measures

Medical Outcomes Study 36-item Short Form Health Survey

Secondary Outcome Measures

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

Full Information

First Posted
August 13, 2001
Last Updated
February 26, 2013
Sponsor
University of Pittsburgh
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00022776
Brief Title
Surgical Versus Nonsurgical Treatment for Spinal Stenosis
Official Title
Randomized Clinical Trial of Treatment for Spinal Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
Human therapy evaluation, Orthopedics, Physical therapy, Nonsurgical treatment, Surgical decompression, Surgery, Lumbar, Spine disorder, Spinal stenosis, Gender difference, Medical rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical decompression
Other Intervention Name(s)
Laminectomy, Foraminotomy
Intervention Description
Simple decompression not requiring fusion.
Intervention Type
Procedure
Intervention Name(s)
Physical therapy
Other Intervention Name(s)
Exercises, Aerobics, Strengthening
Intervention Description
2 physical therapy sessions per week for 6 weeks Followed by home program.
Primary Outcome Measure Information:
Title
Medical Outcomes Study 36-item Short Form Health Survey
Time Frame
Measured at Month 24
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
Measured at Month 24
Title
Oswestry Low Back Pain Disability Scale
Time Frame
Measured at Month 24
Title
MODEMS questionnaires
Time Frame
Measured at Month 24
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Delitto, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25844995
Citation
Delitto A, Piva SR, Moore CG, Fritz JM, Wisniewski SR, Josbeno DA, Fye M, Welch WC. Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial. Ann Intern Med. 2015 Apr 7;162(7):465-73. doi: 10.7326/M14-1420.
Results Reference
derived

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Surgical Versus Nonsurgical Treatment for Spinal Stenosis

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