Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
History of Changes
  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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 September 29, 2016