Battlefield Acupuncture Following Shoulder Surgery

Pain, Postoperative Clinical Trial

— BFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04094246
• Other study ID #: 19KACH003
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: May 29, 2024

Study information

• Verified date: May 2024
• Source: Keller Army Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 29, 2024
• Est. primary completion date: May 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Keller Army Community Hospital - Arvin Physical Therapy	West Point	New York

Sponsors (2)

Lead Sponsor	Collaborator
Keller Army Community Hospital	Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Medication Use	Daily opioid, NSAID, and Acetaminophen use	1 week, 4 weeks
Secondary	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