Battlefield Acupuncture Following Shoulder Surgery (BFA)

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: Recruiting
• Conditions: Pain, Postoperative; Shoulder Injuries; Pain Management; Acupuncture, Ear
• Intervention / Treatment: Procedure: Battlefield Acupuncture; Procedure: Standard post-surgical rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Crowell, PT, DSc; Phone Number: 8459383067; Email: michael.s.crowell.mil@mail.mil

Study Locations

• United States
  • New York
    • West Point, New York, United States, 10966
      • Recruiting
      • Keller Army Community Hospital - Arvin Physical Therapy
      • Contact: Michael Crowell, DPT; Phone Number: 845-938-3067; Email: michael.s.crowell.mil@mail.mil

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire	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	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)	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

• Sponsor: Keller Army Community Hospital
• Collaborators: Uniformed Services University of the Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 1, 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, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Pain, Postoperative; Shoulder Injuries
• 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