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A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults
The purpose of this study is to determine if auricular acupuncture significantly reduces post-operative pain in comparison to the standard of care. Post-operative pain score will be collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0= no pain, 10 = worst imaginable pain) up to 10 days post-operation.
DESIGN: Design type: Prospective, randomized control trial Sample * Description of the population: All adults, greater than or equal to 18 years, undergoing a tonsillectomy with or without adenoidectomy at Womack Army Medical Center are eligible for participation in the study. * Sample Size: 100 subjects. A target of 45 subjects per group for a total of 90 subjects, and accounting for a 10 percent drop out rate. In Fiscal Year 12, 92 tonsilectomies in patients over the age of 12 were performed at Womack Army Medical Center. Therefore, the investigators anticipate the study will take up to 4 years to enroll 100 adult subjects. * Power Analysis: Under the assumption of a linear time by treatment interaction, assuming subject-level randomization, five time-points, power of 80 percent, a Type I error rate of 5 per cent and no attrition, to detect a 1.6 difference in pain score requires a total sample size of 90 subjects or 45 per treatment arm.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Start Date
November 1, 2013
Primary Completion Date
June 8, 2017
Completion Date
August 23, 2017
Last Updated
June 9, 2020
95
ACTUAL participants
Auricular acupuncture
OTHER
Lead Sponsor
Defense and Veterans Center for Integrative Pain Management
NCT06326983
NCT06370208
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06576830