Surgical Versus Nonsurgical Treatment for Spinal Stenosis

February 26, 2013 updated by: University of Pittsburgh

Randomized Clinical Trial of Treatment for Spinal Stenosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medical Outcomes Study 36-item Short Form Health Survey
Time Frame: Measured at Month 24
Measured at Month 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory
Time Frame: Measured at Month 24
Measured at Month 24
Oswestry Low Back Pain Disability Scale
Time Frame: Measured at Month 24
Measured at Month 24
MODEMS questionnaires
Time Frame: Measured at Month 24
Measured at Month 24
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
Measured at Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

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

Investigators

  • Principal Investigator: Anthony Delitto, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 13, 2001

First Submitted That Met QC Criteria

August 14, 2001

First Posted (Estimate)

August 15, 2001

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01 AR45633
  • R01AR045622 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Stenosis

Clinical Trials on Surgical decompression

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe