Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Placebo acupuncture; Other: Battlefield Acupuncture

• Registration Number: NCT02093637
• Lead Sponsor: Mike O'Callaghan Military Hospital

Brief Summary

The purpose of this study is to determine if the addition of Battlefield Auricular Acupuncture (BFA) to standard therapy causes reduction in pain, medication use, time to ambulation without assistance, hours missed from work and increases quality of life after lower extremity surgery at two Air Force Medical Centers.

Detailed Description

We will recruit 429subjects into this research study, for an expected 309 completing the study. We estimate 120 subjects will either withdraw consent or become ineligible for the study. Subjects will be ≥18 years or older and scheduled for lower extremity surgery. To randomize subjects, we will employ a random number generator, which will minimize difference between study groups. Additionally, we will collect data about patients' length of hospital stay, which will allow for statistical control of the variable, complexity of surgical procedure. The Research Assistants/Coordinators will be responsible for obtaining Informed Consent and HIPAA Authorization from subjects, collecting data, and de-identifying data prior to review and analysis by the Investigators. The Investigators will be responsible for ongoing protocol monitoring, insertion of needles, verifying inclusion/exclusion criteria, and analyzing data.

Study Timeline

• Study First Submitted: 2013-07-11
• Study Start: 2013-08
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-21
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

Male and female subjects (DoD beneficiaries), 18 years or older who are scheduled for lower extremity surgery below the hip.

Exclusion Criteria

Pregnant or breastfeeding Absence of their ear Active cellulitis of their ear Ear anatomy precluding identification of acupuncture landmarks Non-English speaking Use of Hearing Aids that preclude the insertion of ASP needles Inability to comply with study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo acupuncture	Placebo acupuncture	Placebo acupuncture up to 5 acupuncture needles\* in each ear (up to 10 needles total) at points identified by point-finder to have no electrical conductance) plus usual operative and post-operative care (narcotic and non-narcotic pain medication).
Battlefield Acupuncture	Battlefield Acupuncture	Usual operative and post-operative care (narcotic and non-narcotic pain medication) plus Battlefield Acupuncture (up to 5 acupuncture needles\* in each ear (up to 10 needles total), identified by a point-finder.

Primary Outcome Measures

Name	Time	Method
Pain score	1 month

Trial Locations

Locations (2)

David Grant Medical Center; 🇺🇸 Travis Air Force Base, California, United States

Mike O'Callaghan Federal Medical Center; 🇺🇸 Nellis Air Force Base, Nevada, United States