CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 289 enrolled
Drug / intervention
Decompressive laminectomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000411
NCT00000411Phase 4Completed

Spine Patient Outcomes Research Trial (SPORT): A Multicenter Trial for Spinal Stenosis (SpS)

Dartmouth-Hitchcock Medical Center·interventional·Posted Nov 4, 1999·Updated Aug 4, 2015

In Brief

A Phase 4 clinical trial evaluating Decompressive laminectomy and Non-surgical treatments for Spinal Stenosis and Low Back Pain. Completed, enrolled 289 participants across 13 sites.

Detailed 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 prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain. Low back pain is one of the most widely experienced health problems in the United States and the world. It is the second most frequent condition, after the common cold, for which people see a doctor or lose days from work. In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) with a type of surgery known as posterior decompressive laminectomy or with nonsurgical methods. This study does not cover the cost of treatment.

Study Details

Timeline

Phase 4CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartMar 1, 2000
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 15.1 yearsPosted 26.7 years ago

Interventions

Decompressive laminectomyprocedure

Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis.

Non-surgical treatmentsother

Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated