Battlefield Acupuncture Following Shoulder Surgery
- Conditions
- Shoulder InjuriesPain, PostoperativeAcupuncture, EarPain Management
- Interventions
- Procedure: Battlefield AcupunctureProcedure: Standard post-surgical rehabilitation
- Registration Number
- NCT04094246
- Lead Sponsor
- Keller Army Community Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group Battlefield Acupuncture Participants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture. Control Group Standard post-surgical rehabilitation Participants in the control group will receive standard post-surgical rehabilitation protocol per their surgery.
- Primary Outcome Measures
Name Time Method Worst overall pain assessed by Visual Analogue Scale (VAS) 72 hours, 1 week 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.
Average 24-hour pain assessed by Visual Analogue Scale (VAS) 72 hours, 1 week 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.
- Secondary Outcome Measures
Name Time Method Medication Use 1 week, 4 weeks Daily opioid, NSAID, and Acetaminophen use
Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS) 4 weeks 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.
Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire 72 hours, 1 week, 4 weeks 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.
Trial Locations
- Locations (1)
Keller Army Community Hospital - Arvin Physical Therapy
🇺🇸West Point, New York, United States