Accession Number:

AD1007009

Title:

Treating Intractable Post-Amputation Phantom Limb Pain with Ambulatory Continuous Peripheral Nerve Blocks

Descriptive Note:

Technical Report,26 Dec 2014,25 Dec 2015

Corporate Author:

University of California, San Diego La Jolla United States

Personal Author(s):

Report Date:

2016-01-01

Pagination or Media Count:

34.0

Abstract:

This is a randomized, double-masked, placebo-controlled clinical trial. The results will not be available until the completion of enrollment and unmasking of treatment groups. Therefore, there are no resultsfindings to report at this juncture as we are still completing enrollment. The tasks of Funding Year 3 encompassed continued recruiting, enrollment and data collection 52 subjects enrolled to date for all centers 21 subjects provided crossover treatment Expanded recruiting advertisements to multiple national publications and websites IRB-approved recruitment letters sent to prospective subjects Amputee support group outreach, prosthetics groups outreach, and clinic outreach conducted Data collection ongoing for all enrolled subjects Re-budgeted among enrolling sites due to uneven enrollment Completed the first interim analysis after 32 subjects results remained masked for treatment group and revealed only to the DSMB, which recommended continuing with enrollment

Subject Categories:

Distribution Statement:

APPROVED FOR PUBLIC RELEASE