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

NCT00220935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2006-10-05

No results posted yet for this study

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.

Conditions

  • Radiating Leg Pain
  • Disc Protrusion

Interventions

DEVICE

Orthotrac Pneumatic Vest

Sponsors & Collaborators

  • Innovative Spinal Technologies, Inc.

    collaborator INDUSTRY

  • Orthofix Inc.

    collaborator INDUSTRY

  • Texas Back Institute

    lead OTHER

Principal Investigators

  • John J. Triano, DC,PhD · Texas Back Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Completion
2006-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00220935 on ClinicalTrials.gov