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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220935
First Posted: September 22, 2005
Last Update Posted: October 5, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Innovative Spinal Technologies, Inc.
Orthofix Inc.
Information provided by:
Texas Back Institute
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Orthotrac Pneumatic Vest: A Randomized, Controlled Trial of Treatment for Disc Herniation With Radiating Leg Pain

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00220935     History of Changes
Other Study ID Numbers: P608
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: October 5, 2006
Last Verified: July 2005

Keywords provided by Texas Back Institute:
Randomized controlled clinical trial