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Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

This study is currently recruiting participants.
Verified February 2013 by United States Naval Medical Center, San Diego
Sponsor:
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01790477
First received: February 11, 2013
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Recurrent Tonsillitis
Recurrent Peritonsillar Abscess
Obstructive Sleep Apnea
 Procedure: Auricular Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: AURICULAR ACUPUNCTURE FOR THE TREATMENT OF POST-TONSILLECTOMY PAIN

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Reduction in VAS scores between experimental and control group [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auricular Acupuncture
Use of auricular acupuncture in bilateral ears
 Procedure: Auricular Acupuncture
Application of auricular acupuncture to 5 points on the ear
Placebo Comparator: Control group
No needles with bandages on ears.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790477

Contacts
Contact: Anil N Shah, MD anil.shah@med.navy.mil

Locations
United States, California
NMCSD Balboa Recruiting
San Diego, California, United States, 92104
Contact: Anil Shah, MD     619-532-6818     anil.shah@med.navy.mil    
Principal Investigator: Anil N Shah            
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Anil Shah NMCSD
  More Information

No publications provided

Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01790477     History of Changes
Other Study ID Numbers: NMCSD.2012.0102
Study First Received: February 11, 2013
Last Updated: February 12, 2013
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:
Tonsillectomy
Acupuncture

Additional relevant MeSH terms:
Abscess
Peritonsillar Abscess
Sleep Apnea Syndromes
Tonsillitis
Sleep Apnea, Obstructive
Suppuration
Infection
Inflammation
Pathologic Processes
Pharyngitis
Pharyngeal Diseases
 Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013