Status:
COMPLETED
A Randomized, Controlled Trial of Treatment for Disc Herniation With Radiating Leg Pain
Lead Sponsor:
Texas Back Institute
Collaborating Sponsors:
Innovative Spinal Technologies, Inc.
Orthofix Inc.
Conditions:
Radiating Leg Pain
Disc Protrusion
Eligibility:
All Genders
21-55 years
Phase:
NA
Brief Summary
Hypothesis - This study is designed to evaluate the results of using the Orthotrac Pneumatic Vest versus an EZ form brace in patients with radiating leg pain from disc bulge / protrusion / herniation....
Detailed Description
Patient Inclusion / Exclusion Criteria: Patient's who present with low back and unilateral leg pain are potential candidates for recruitment in this study. For purposes of the research, leg pain will...
Eligibility Criteria
Inclusion
- Age 21 - 55
- Preferred no prior surgery or no spine surgery in previous 6 months.
- VAS \> 4.0
- Symptoms unresolved after 4 weeks
- Minimal antalgic lean of the trunk when initially weight bearing
- Pain aggravated by weight bearing standing / walking
- Reduced leg pain on recumbency
- MRI Confirmed disc bulge / protrusion / herniation (HNP) site consistent with symptoms - preferred.
Exclusion
- · No neurological deficit
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00220935
Start Date
January 1 2003
End Date
July 1 2006
Last Update
October 5 2006
Active Locations (1)
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1
Texas Back Institute
Plano, Texas, United States, 75082