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Ear Acupuncture for Post-operative Pain Associated With Ambulatory Arthroscopic Knee Surgery - A Randomized Controlled Trial (BFA Knee)

This study is currently recruiting participants.
Verified April 2012 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01447329
First received: October 4, 2011
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

The investigators propose to complete a randomized controlled trial to compare ear acupuncture at Cingulate gyrus, thalamus, omega 2, shen-men, and point zero on the right and left ear plus standard of care versus standard of care alone for symptomatic treatment of pain following ambulatory arthroscopic knee surgery. After the subject has been discharged, phone calls, emails or text messages will be made at 24 and 48 hours, 1 week and 1 month. These contacts will be used to assess the subject's pain level, ambulation status, doses of analgesics taken and time to return to full duty. At 1 week and 1 month, subjects will be asked the PIQ-6 Pain Impact Questionnaire.


Condition Intervention
Pain
 Other: Ear Acupuncture
Drug: Standard Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Ear Acupuncture for Post-operative Pain Associated With Ambulatory Arthroscopic Knee Surgery - A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • Number of participants with a decrease in pain level [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Number of participants with a decrease in pain medication doses [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard treatment alone Drug: Standard Treatment
Analgesics
Experimental: Standard treatment plus ear acupuncture Other: Ear Acupuncture
Ear acupuncture utilizes up to 10 needles. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The subject will receive five needles intra-operatively on each ear.
Other Name: Sedatelec ASP Original Gold needles

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Tricare beneficiaries recieving care at Nellis AFB.
  • Male and female subjects (DoD beneficiaries), 18 years or older scheduled for ambulatory unilateral arthroscopic knee surgery.
  • Unilateral arthroscopic knee surgery debridement.

Exclusion:

  • History of significant gastrointestinal bleed
  • Previous documented history of stage 2 kidney disease or worse
  • Pregnant or breastfeeding
  • History of gastric bypass surgery
  • Chronic oral steroids use
  • Absence of ear
  • Active cellulitis of ear
  • Ear anatomy precluding identification of acupuncture landmarks
  • Non-English speaking
  • Taking Coumadin or any Heparin-based anticoagulant
  • Use of Hearing Aids that preclude the insertion of ASP needles
  • Allergy to study medications
  • Inability to comply with study protocol
  • Arthroscopic knee surgery with ligamentous repair
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447329

Contacts
Contact: Jennie Moss, MS, RN 702-653-2113 jennie.moss@nellis.af.mil
Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC 702-653-2756 jill.teixeira@nellis.af.mil

Locations
United States, Nevada
Mike O'Callaghan Federal Hospital Recruiting
Nellis ABF, Nevada, United States, 89191
Contact: Jennie Moss, MS, RN     702-653-2113     jennie.moss@nellis.af.mil    
Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC     702-653-2756     jill.teixeira@nellis.af.mil    
Principal Investigator: David Moss, M.D., Capt            
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
Principal Investigator: David Moss, M.D., Capt Mike O'Callaghan Federal Hospital/Nellis AFB
  More Information

No publications provided

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01447329     History of Changes
Other Study ID Numbers: FWH20110169H
Study First Received: October 4, 2011
Last Updated: April 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Mike O'Callaghan Federal Hospital:
pain
acupuncture
knee
 debridement
surgery
arthroscopic knee surgery debridement

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013