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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00797849
Other study ID # #871
Secondary ID Contract 1 EA-00
Status Completed
Phase N/A
First received November 24, 2008
Last updated March 12, 2012
Start date November 2008
Est. completion date November 2011

Study information

Verified date March 2012
Source Southern California Institute for Research and Education
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to determine if the group using Farabloc shows a greater reduction in pain levels than the group not using Farabloc at 6-week, 12-week and 1-month post treatment follow-ups.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Farabloc Limb Cover
Wear prosthetics, sock or glove laminated with Farabloc
Sham Limb Cover
Wear prosthetics, sock or glove laminated with sham material

Locations

Country Name City State
United States VA Long Beach Healthcare System Long Beach California

Sponsors (2)

Lead Sponsor Collaborator
Southern California Institute for Research and Education Samueli Institute for Information Biology

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome will be pain as measured by the Numerical Pain Rating Scale (NPRS). Measurements will be obtained at baseline, and 6-week and 12-week follow-ups No
Secondary A secondary outcome will measure health-related quality of life using the 36-item Sort Form Health Survey (SF-36). The assessment will be conducted at pretest, 6-week, 12-week and 1-month post treatment. No
Secondary Measurement of health care utilization will be conducted by comparing the numbers of outpatient visits emergency room visits and inpatient hospitalizations using the VA electronic medical system CPRS. At 12-week pretreatment and 12-week follow-up. No
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