Status:

COMPLETED

Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis

Lead Sponsor:

Dartmouth-Hitchcock Medical Center

Collaborating Sponsors:

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

National Institute for Occupational Safety and Health (NIOSH/CDC)

Conditions:

Spinal Stenosis

Low Back Pain

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescrib...

Detailed Description

Low back pain is considered one of the most widely experienced health problems in the U.S. and the world. It is the second most frequent condition, after the common cold, for which patients see a phys...

Eligibility Criteria

Inclusion Criteria:

  • Duration of Symptoms: 12 or more weeks.
  • Treatments tried: Nonsteroidal anti-inflammatory medical therapy and physical therapy.
  • Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms.
  • Tests: MRI to confirm diagnosis and level(s).

Exclusion Criteria:

  • Previous lumbar spine surgery.
  • Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months.
  • Possible pregnancy.
  • Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years.
  • Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
  • Age less than 18 years.
  • Cauda equina syndrome or progressive neurologic deficit (usually requiring urgent surgery).
  • Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys.
  • Symptoms less than 12 weeks.
  • Patient currently enrolled in any experimental "spine related" study.

Key Trial Info

Start Date :

March 1 2000

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2015

Estimated Enrollment :

289 Patients enrolled

Trial Details

Trial ID

NCT00000411

Start Date

March 1 2000

End Date

April 1 2015

Last Update

August 4 2015

Active Locations (13)

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Page 1 of 4 (13 locations)

1

Kaiser Permanente Spine Care Program

Oakland, California, United States, 94612

2

University of California, San Francisco (UCSF)

San Francisco, California, United States, 94143-0728

3

Emory University, The Emory Clinic

Decatur, Georgia, United States, 30033

4

Rush-Presbyterian, St. Luke's Medical Center

Chicago, Illinois, United States, 60612-3833