Battlefield Acupuncture Following Shoulder Surgery (BFA)

Keller Army Community Hospital

Status: Completed

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

Treatments: Procedure: Standard post-surgical rehabilitation; Procedure: Battlefield Acupuncture

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04094246

19KACH003

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 17 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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

Treatment:

Procedure: Battlefield Acupuncture

Control Group

Active Comparator group

Description:

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

Treatment:

Procedure: Standard post-surgical rehabilitation