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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

About this trial

This is an interventional treatment trial for Recurrent Tonsillitis focused on measuring Tonsillectomy, Acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

Learn more about this trial

Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

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