NCT00220935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

October 5, 2006

Status Verified

July 1, 2005

First QC Date

September 13, 2005

Last Update Submit

October 4, 2006

Conditions

Radiating Leg PainDisc Protrusion

Keywords

Randomized controlled clinical trial

Outcome Measures

Primary Outcomes (3)

  • VAS

  • Oswestry

  • SF-36

Secondary Outcomes (5)

  • ROM

  • Pain drawing

  • Medication use

  • Wear compliance

  • Extra-protocol treatment seeking

Interventions

Orthotrac Pneumatic VestDEVICE

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Back Institute

Plano, Texas, 75082, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • John J. Triano, DC,PhD

    Texas Back Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

January 1, 2003

Study Completion

July 1, 2006

Last Updated

October 5, 2006

Record last verified: 2005-07

Locations

US(1)