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

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ClinicalTrials.gov Identifier: NCT00220935
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 5, 2006
Sponsor:
Collaborators:
Innovative Spinal Technologies, Inc.
Orthofix Inc.
Information provided by:
Texas Back Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Radiating Leg Pain Disc Protrusion Device: Orthotrac Pneumatic Vest Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
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
Study Start Date : January 2003
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. VAS
  2. Oswestry
  3. SF-36

Secondary Outcome Measures :
  1. ROM
  2. Pain drawing
  3. Medication use
  4. Wear compliance
  5. Extra-protocol treatment seeking

Eligibility Criteria
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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
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Keywords provided by Texas Back Institute:
Randomized controlled clinical trial