Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery

Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Placebo acupuncture; Other: Battlefield Acupuncture

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 Type: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Travis Air Force Base, California, United States, 94535
      • David Grant Medical Center
  • Nevada
    • Nellis Air Force Base, Nevada, United States, 89191
      • Mike O'Callaghan Federal Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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).	Other: Placebo acupuncture; Placebo Comparator; Other Names: ASP needles
Experimental: 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.	Other: Battlefield Acupuncture; Experimental; Other Names: ASP needles
No Intervention: standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain score	1 month

Collaborators and Investigators

• Sponsor: Mike O'Callaghan Military Hospital
• Investigators: Principal Investigator: Paul Crawford, MD, MOFMC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: March 19, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: FDG20120024H