Skip to main content
OpenTrials
Completed

NCT Number: NCT04094246

Battlefield Acupuncture Following Shoulder Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Injuries Acupuncture, Ear Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

17 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keller Army Community Hospital - Arvin Physical Therapy

West Point, New York, 10966, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Battlefield Acupuncture

Procedure

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.

Standard post-surgical rehabilitation

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. Medication Use

    Time frame: 1 week, 4 weeks

    Daily opioid, NSAID, and Acetaminophen use

  3. 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.

Sponsors and collaborators

Lead sponsor

Keller Army Community Hospital

Fed

Collaborators

  • Uniformed Services University of the Health Sciences

Registry information

Official study title

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

Acronym: BFA

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2019
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.