Search / Trial NCT00000409

Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis

Launched by DARTMOUTH-HITCHCOCK MEDICAL CENTER · Nov 3, 1999

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Intervertebral Disc Herniation (Idh) Degenerative Spondylolisthesis (Ds) Spinal Stenosis (Sp S) Low Back Pain (Lbp) Leg Pain Surgical Therapy Randomized Study Multicenter Mri Nonsurgical Therapy

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 physician or lose days from work. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply over time, and researchers have documented 15-fold geographic variation in rates of these surgeries. In many cases, where one lives and who one sees for the condition appear to determine the rates of su...

Gender

All

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.

Attachments

readout_NCT00000409_2024-07-23.pdf

4.5 MB

NCT00000409_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

St. Louis, Missouri, United States

Oakland, California, United States

San Francisco, California, United States

Decatur, Georgia, United States

Chicago, Illinois, United States

Scarborough, Maine, United States

Royal Oak, Michigan, United States

Omaha, Nebraska, United States

Lebanon, New Hampshire, United States

New York, New York, United States

New York, New York, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Baseline, 6 wks, 3 and 6 mos, Annually thereafter

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
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2 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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