Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain
Primary Purpose
Recurrent Tonsillitis, Peritonsillar Abscess, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Tonsillitis focused on measuring Tonsillectomy, Acupuncture
Eligibility Criteria
Inclusion Criteria:
- Any adult patient who meets criteria and is scheduled for tonsillectomy
Exclusion Criteria:
- Any patient with prior use of acupuncture
- Individuals under age 18
- Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy,
- Patients with a known personal or family history of a bleeding disorder will be excluded.
- Patients with a history of kidney or liver problems will also be excluded.
- Patients found to be pregnant will be excluded from participation.
- Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.
Sites / Locations
- NMCSD Balboa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Auricular Acupuncture
Control
Arm Description
Use of auricular acupuncture in bilateral ears
Outcomes
Primary Outcome Measures
Reduction in VAS scores between experimental and control group
Secondary Outcome Measures
Full Information
NCT ID
NCT01790477
First Posted
February 11, 2013
Last Updated
April 5, 2016
Sponsor
United States Naval Medical Center, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01790477
Brief Title
Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain
Official Title
Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Naval Medical Center, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. Secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or improved response with acupuncture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Tonsillitis, Peritonsillar Abscess, Obstructive Sleep Apnea
Keywords
Tonsillectomy, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular Acupuncture
Arm Type
Experimental
Arm Description
Use of auricular acupuncture in bilateral ears
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Auricular Acupuncture
Intervention Description
Application of auricular acupuncture to 5 points on the ear
Primary Outcome Measure Information:
Title
Reduction in VAS scores between experimental and control group
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any adult patient who meets criteria and is scheduled for tonsillectomy
Exclusion Criteria:
Any patient with prior use of acupuncture
Individuals under age 18
Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy,
Patients with a known personal or family history of a bleeding disorder will be excluded.
Patients with a history of kidney or liver problems will also be excluded.
Patients found to be pregnant will be excluded from participation.
Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Shah
Organizational Affiliation
NMCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMCSD Balboa
City
San Diego
State/Province
California
ZIP/Postal Code
92104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain
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