Ear Acupuncture for Pain Associated With Ambulatory Arthroscopic Knee Surgery (BFAKnee)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01447329
First received: October 4, 2011
Last updated: March 19, 2014
Last verified: March 2014
  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:


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 ]

Secondary Outcome Measures:
  • Number of patients with reduced analgesic use [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard treatment plus ear acupuncture
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
Placebo Comparator: standard
placebo
Drug: Standard Treatment

  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 receiving 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447329

Locations
United States, Nevada
Mike O'Callaghan Federal Hospital
Nellis ABF, Nevada, United States, 89191
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: March 19, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 20, 2014