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

This study has been completed.
Sponsor:
Collaborators:
Innovative Spinal Technologies, Inc.
Orthofix Inc.
Information provided by:
Texas Back Institute
ClinicalTrials.gov Identifier:
NCT00220935
First received: September 13, 2005
Last updated: October 4, 2006
Last verified: July 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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

ClinicalTrials.gov Identifier: NCT00220935     History of Changes
Other Study ID Numbers: P608
Study First Received: September 13, 2005
Last Updated: October 4, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Texas Back Institute:
Randomized controlled clinical trial

ClinicalTrials.gov processed this record on April 16, 2014