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Sponsors and Collaborators: |
Texas Back Institute Innovative Spinal Technologies, Inc. Orthofix, Inc. |
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Information provided by: | Texas Back Institute |
ClinicalTrials.gov Identifier: | NCT00220935 |
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. Specifically, our hypothesis is that patients given the Orthotrac Pneumatic Vest (OPV) will have greater pain relief and increased self-reported functionality and fewer progressions to surgery than those using the EZ form brace.
Condition | Intervention |
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Radiating Leg Pain Disc Protrusion |
Device: Orthotrac Pneumatic Vest |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Orthotrac Pneumatic Vest: A Randomized, Controlled Trial of Treatment for Disc Herniation With Radiating Leg Pain |
Estimated Enrollment: | 150 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 21 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Texas Back Institute | |
Plano, Texas, United States, 75082 |
Principal Investigator: | John J. Triano, DC,PhD | Texas Back Institute |
Study ID Numbers: | P608 |
Study First Received: | September 13, 2005 |
Last Updated: | October 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00220935 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Randomized controlled clinical trial |
Hernia Pain |