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Battlefield Acupuncture for Shoulder Injuries (BFA Trial)
N/A
Recruiting
Research Sponsored by Keller Army Community Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours, 1 week, 4 weeks
Awards & highlights
BFA Trial Summary
This trial is testing whether adding acupuncture to standard shoulder rehab can help reduce pain and reliance on pain medication after surgery.
Who is the study for?
This trial is for Department of Defense beneficiaries aged 17-55 who are either about to have shoulder surgery or had it within the last 48 hours. It's specifically for those undergoing shoulder stabilization or rotator cuff repair. Emancipated cadets at the U.S. Military Academy can also join if they're 17.Check my eligibility
What is being tested?
The study is testing Battlefield Acupuncture (BFA) alongside standard post-surgical physical therapy against just regular rehabilitation after shoulder surgery. The goal is to see if BFA helps reduce pain and medication use, with assessments up to four weeks post-surgery.See study design
What are the potential side effects?
While specific side effects aren't listed, acupuncture typically has minimal risks which may include slight bleeding, bruising at needle sites, and rare cases of dizziness or fainting.
BFA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours, 1 week, 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours, 1 week, 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average 24-hour pain assessed by Visual Analogue Scale (VAS)
Worst overall pain assessed by Visual Analogue Scale (VAS)
Secondary outcome measures
Medication Use
Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire
Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS)
BFA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental GroupExperimental Treatment1 Intervention
Participants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture.
Group II: Control GroupActive Control1 Intervention
Participants in the control group will receive standard post-surgical rehabilitation protocol per their surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Battlefield Acupuncture
2016
Completed Phase 2
~410
Find a Location
Who is running the clinical trial?
Keller Army Community HospitalLead Sponsor
15 Previous Clinical Trials
1,979 Total Patients Enrolled
1 Trials studying Shoulder Injuries
40 Patients Enrolled for Shoulder Injuries
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
91,503 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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