Battlefield Acupuncture Following Shoulder Surgery (BFA)

February 21, 2025 updated by: Michael Crowell, Keller Army Community Hospital

The Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone Following Shoulder Surgery: A Randomized Clinical Trial

The purpose of this randomized clinical trial is to determine the effectiveness of Battlefield Acupuncture (BFA) in addition to standard post-surgical shoulder physical therapy compared to a standard shoulder rehabilitation program in reducing medication use and pain in patients who have undergone shoulder surgery. Measurements of medication (opioid, NSAID, acetaminophen, etc.) use (daily number of pills consumed), pain rating, patient specific functional scale and global rating of change will be taken at 48-hours (baseline), 72-hours, 1-week, and 4-weeks post-surgery. It is hypothesized that the inclusion of Battlefield Acupuncture will result in a decrease in post-surgical pain levels, reduced opioid medication use, and improved patient mood when compared to rehabilitation alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • West Point, New York, United States, 10966
        • Keller Army Community Hospital - Arvin Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 17-55 Department of Defense beneficiaries (17 only if an emancipated cadet at the U.S. Military Academy)
  • Prior to or within 48 hours post shoulder stabilization surgery
  • Prior to or within 48 hours post rotator cuff repair surgery

Exclusion Criteria:

  • Self-reported pregnancy
  • History of blood borne pathogens, infectious disease, or active infection
  • History of metal allergy
  • History of bleeding disorders or currently taking anti-coagulant medications
  • Participants who are not fluent in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Participants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture.
Procedure: Battlefield Acupuncture
Battlefield Acupuncture (BFA), an auricular acupuncture protocol developed in 2001 by Dr. Niemtzow (Ret. Colonel, USAF), is widely used among civilian and military medical providers to treat pain. Participants in the Experimental Group will receive BFA in addition to standard post-surgical rehabilitation up to four times following their shoulder surgery: 24-hours, 48-hours, 72-hours, and 1-week post-surgery.
Active Comparator: Control Group
Participants in the control group will receive standard post-surgical rehabilitation protocol per their surgery.
Procedure: Standard post-surgical rehabilitation
Participants will receive rehabilitation and will perform a home exercise program in accordance with the standard post-operative shoulder protocol. Participants will be asked to record compliance on an exercise log.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worst overall pain assessed by Visual Analogue Scale (VAS)
Time Frame: 72 hours, 1 week
Worst pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
72 hours, 1 week
Average 24-hour pain assessed by Visual Analogue Scale (VAS)
Time Frame: 72 hours, 1 week
Average pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
72 hours, 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire
Time Frame: 72 hours, 1 week, 4 weeks
The POMS consists of 65 measures of mood organized into 6 mood scales: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Individual scales are combined to achieve the mood disturbance score (MDS), an aggregate indicator of overall mood. A greater MDS value indicates greater mood disturbance.
72 hours, 1 week, 4 weeks
Medication Use
Time Frame: 1 week, 4 weeks
Daily opioid, NSAID, and Acetaminophen use
1 week, 4 weeks
Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS)
Time Frame: 4 weeks
Worst pain intensity and average pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keller Army Community Hospital

Collaborators

Uniformed Services University of the Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2019

Primary Completion (Actual)

May 29, 2024

Study Completion (Actual)

May 29, 2024

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19KACH003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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