A Randomized, Controlled Trial of Treatment for Disc Herniation With Radiating Leg Pain

This study has been completed.

First Received: September 13, 2005 Last Updated: October 4, 2006 History of Changes

Sponsors and Collaborators:	Texas Back Institute Innovative Spinal Technologies, Inc. Orthofix, Inc.
Information provided by:	Texas Back Institute
ClinicalTrials.gov Identifier:	NCT00220935

Purpose

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
Radiating Leg Pain Disc Protrusion	Device: Orthotrac Pneumatic Vest

MedlinePlus related topics: Hernia

U.S. FDA Resources

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

Further study details as provided by Texas Back Institute:

Primary Outcome Measures:

VAS
Oswestry
SF-36

Secondary Outcome Measures:

ROM
Pain drawing
Medication use
Wear compliance
Extra-protocol treatment seeking

Estimated Enrollment:	150
Study Start Date:	January 2003
Estimated Study Completion Date:	July 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

No neurological deficit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220935

Locations

United States, Texas
Texas Back Institute
Plano, Texas, United States, 75082

Sponsors and Collaborators

Texas Back Institute

Innovative Spinal Technologies, Inc.

Orthofix, Inc.

Investigators

Principal Investigator:

John J. Triano, DC,PhD

Texas Back Institute

More Information

No publications provided

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

Keywords provided by Texas Back Institute:

Randomized controlled clinical trial

Study placed in the following topic categories:

Hernia
Pain

ClinicalTrials.gov processed this record on May 06, 2009