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

Completed · Not applicable

Conditions studied: Radiating Leg Pain, Disc Protrusion

In brief

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.

Key facts

Study ID

NCT00220935

Run by

Texas Back Institute

People needed

150

Starts

2003-01-01

Expected to finish

2006-07-01

Last updated by the study team

2006-10-05

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• · No neurological deficit

Where it is running

• Texas Back Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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