Battlefield Acupuncture Following Shoulder Surgery

NCT04094246 | Completed

• 1 other identifier: 19KACH003
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Injuries; Pain, Postoperative; Acupuncture, Ear; Pain Management

Outcome Measures

Primary Outcomes (2)

• Worst overall pain assessed by Visual Analogue Scale (VAS)

  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)

  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 Outcomes (3)

• Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire

  72 hours, 1 week, 4 weeks

• Medication Use

  1 week, 4 weeks

• Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS)

  4 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture.

Procedure: Battlefield Acupuncture

Control Group

ACTIVE COMPARATOR

Participants in the control group will receive standard post-surgical rehabilitation protocol per their surgery.

Procedure: Standard post-surgical rehabilitation

Interventions

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.

Experimental Group

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.

Control Group

Eligibility Criteria

• Age: 17 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keller Army Community Hospital: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Keller Army Community Hospital - Arvin Physical Therapy

West Point, New York, 10966, United States

Location

Related Publications (2)

• Crowell MS, Florkiewicz EM, Morris JB, Mason JS, Pitt W, Benedict T, Cameron KL, Goss DL. Battlefield Acupuncture Does Not Provide Additional Improvement in Pain When Combined With Standard Physical Therapy After Shoulder Surgery: A Randomized Clinical Trial. Mil Med. 2025 Jun 30;190(7-8):e1509-e1517. doi: 10.1093/milmed/usae577.

  PMID: 39797512 RESULT

• Crowell MS, Brindle RA, Mason JS, Pitt W, Miller EM, Posner MA, Cameron KL, Goss DL. The effectiveness of battlefield acupuncture in addition to standard physical therapy treatment after shoulder surgery: a protocol for a randomized clinical trial. Trials. 2020 Dec 3;21(1):995. doi: 10.1186/s13063-020-04909-8.

  PMID: 33272311 DERIVED

MeSH Terms

Conditions

Shoulder Injuries; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director & Associate Professor

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: September 25, 2019
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)