Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

Obstructive Sleep Apnea Clinical Trial

Official title:

Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790477
• Other study ID #: NMCSD.2012.0102
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: April 5, 2016
• Start date: November 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2016
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Peritonsillar Abscess
• Recurrent Tonsillitis
• Sleep Apnea, Obstructive
• Tonsillitis

Intervention

Procedure:
• Auricular Acupuncture
Application of auricular acupuncture to 5 points on the ear

Locations

Country	Name	City	State
United States	NMCSD Balboa	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in VAS scores between experimental and control group		2 weeks	No