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OpenTrials
Completed

NCT Number: NCT00022776

Surgical Versus Nonsurgical 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical decompression

Procedure

Simple decompression not requiring fusion.

Other names: Laminectomy, Foraminotomy

physical therapy

Procedure

2 physical therapy sessions per week for 6 weeks Followed by home program.

Other names: Exercises, Aerobics, Strengthening

Primary outcomes

  1. Medical Outcomes Study 36-item Short Form Health Survey

    Time frame: Measured at Month 24

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

Randomized Clinical Trial of Treatment for Spinal Stenosis

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2001
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.