Clinical trial NCT04094246: Battlefield Acupuncture Following Shoulder Surgery
Official title: The Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone Following Shoulder Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Injuries
Pain, Postoperative
Acupuncture, Ear
Pain Management
Lead sponsor: Keller Army Community Hospital
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
First posted: 2019-09-18
Enrollment: 95
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Worst overall pain assessed by Visual Analogue Scale (VAS)
timeFrame: 72 hours, 1 week
measure: Average 24-hour pain assessed by Visual Analogue Scale (VAS)
timeFrame: 72 hours, 1 week
Secondary outcomes:
measure: Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire
timeFrame: 72 hours, 1 week, 4 weeks
measure: Medication Use
timeFrame: 1 week, 4 weeks
measure: Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: West Point
country: United States
facility: Keller Army Community Hospital - Arvin Physical Therapy
state: New York
Study officials:
References:
citation: 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 Jan 11:usae577. doi: 10.1093/milmed/usae577. Online ahead of print.
citation: 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.