Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

NCT01790477 | Completed DMC

• 1 other identifier: NMCSD.2012.0102
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Tonsillitis; Peritonsillar Abscess; Obstructive Sleep Apnea

Keywords

Tonsillectomy; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Reduction in VAS scores between experimental and control group

  2 weeks

Study Arms (2)

Auricular Acupuncture

EXPERIMENTAL

Use of auricular acupuncture in bilateral ears

Procedure: Auricular Acupuncture

Control

NO INTERVENTION

Interventions

Auricular Acupuncture PROCEDURE

Application of auricular acupuncture to 5 points on the ear

Auricular Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any adult patient who meets criteria and is scheduled for tonsillectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

NMCSD Balboa

San Diego, California, 92104, United States

Location

MeSH Terms

Conditions

Tonsillitis; Peritonsillar Abscess; Sleep Apnea, Obstructive

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Abscess; Suppuration; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Anil Shah

  NMCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 13, 2013
• Study Start: November 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)