Status:

COMPLETED

Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation

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:

Herniated Disc

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 lumbar (lower) spine conditions. The purpose of the study is to learn which of two commonly prescribed ...

Detailed Description

Low back pain is considered one of the most widely experienced health problems in the United States and the world. This condition is the second most frequent condition, after the common cold, for whic...

Eligibility Criteria

Inclusion Criteria:

  • Duration of symptoms: 6 or more weeks.
  • Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy.
  • Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising.
  • 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 which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months.
  • Possible pregnancy.
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no 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 neurological deficit (usually requiring urgent surgery).
  • Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys.
  • Symptoms less than 6 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 :

501 Patients enrolled

Trial Details

Trial ID

NCT00000410

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

San Francisco, California, United States, 94143-0728

3

The Emory Clinic, Emory University

Decatur, Georgia, United States, 30033

4

Rush-Presbyterian, St. Luke's Medical Center

Chicago, Illinois, United States, 60612-3833