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Surgical Versus Nonsurgical Treatment for Spinal Stenosis

Randomized Clinical Trial of Treatment for Spinal Stenosis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00022776
Enrollment
178
Registered
2001-08-15
Start date
2000-09-30
Completion date
2007-12-31
Last updated
2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis

Keywords

Human therapy evaluation, Orthopedics, Physical therapy, Nonsurgical treatment, Surgical decompression, Surgery, Lumbar, Spine disorder, Spinal stenosis, Gender difference, Medical rehabilitation

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.

Interventions

Simple decompression not requiring fusion.

PROCEDUREPhysical therapy

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

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Medical Outcomes Study 36-item Short Form Health SurveyMeasured at Month 24

Secondary

MeasureTime frame
Beck Depression InventoryMeasured at Month 24
Oswestry Low Back Pain Disability ScaleMeasured at Month 24
MODEMS questionnairesMeasured at Month 24
Physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill testMeasured at Month 24

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026