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A Randomized, Controlled Trial of Treatment for Disc Herniation With Radiating Leg Pain
This study has been completed.
Sponsor:
Texas Back Institute
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
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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-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 (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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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
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 |
Keywords provided by Texas Back Institute:
|
Randomized controlled clinical trial |
ClinicalTrials.gov processed this record on June 23, 2017