Clinical trial NCT00022776: Surgical Versus Nonsurgical Treatment for Spinal Stenosis
Official title: Randomized Clinical Trial of Treatment for Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Stenosis
Keywords: Human therapy evaluation
Orthopedics
Physical therapy
Nonsurgical treatment
Surgical decompression
Surgery
Lumbar
Spine disorder
Spinal stenosis
Gender difference
Medical rehabilitation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2001-08-15
Enrollment: 178
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Medical Outcomes Study 36-item Short Form Health Survey
timeFrame: Measured at Month 24
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Measured at Month 24
measure: Oswestry Low Back Pain Disability Scale
timeFrame: Measured at Month 24
measure: MODEMS questionnaires
timeFrame: Measured at Month 24
measure: Physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill test
timeFrame: Measured at Month 24
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Anthony Delitto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.