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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Radiating Leg Pain Disc Protrusion | Device: Orthotrac Pneumatic Vest | Not Applicable |

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 |

- VAS
- Oswestry
- SF-36
- ROM
- Pain drawing
- Medication use
- Wear compliance
- Extra-protocol treatment seeking

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Texas | |
Texas Back Institute | |
Plano, Texas, United States, 75082 |
Principal Investigator: | John J. Triano, DC,PhD | Texas Back Institute |
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 |