Clinical Trials Logo

Clinical Trial Summary

The purpose of this randomized clinical trial is to determine the effectiveness of Battlefield Acupuncture (BFA) in addition to usual 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 24, 72 hours, 7 days, 14 days and at six weeks post-surgery. It is hypothesized that the inclusion of Battlefield Acupuncture will result in a decrease in medication use and post-surgical pain when compared to rehabilitation alone. The population for this study is male and female DoD beneficiaries, ages 17-55 (17 if cadet) that are not participating in other shoulder research studies. The subjects in the experimental group will receive Battlefield Acupuncture in addition to their respective post-surgical shoulder rehabilitation protocol.


Clinical Trial Description

GROUPS Group assignment will be recorded with individual subject identifier and secured in a separate folder until completion of all data collection through the final follow up.

- Experimental Group: Battlefield Acupuncture with respective shoulder surgery protocol

- Control Group: respective post-surgical Shoulder protocol

All Battlefield Acupuncture will be performed by the PI or AI's who are trained in Battlefield Acupuncture. The Battlefield Acupuncture technique will be standardized. The subject will continue to receive the standard of care in accordance with the post-operative protocol between follow-ups.

Experimental Group: Subjects in the experimental group will receive the usual post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture. Using sterile technique, Battlefield acupuncture using the 5 points within the Battlefield Acupuncture protocol will be used until the desired 0-1/10 VAS is reported by the subject. The sequencing of the acupuncture begins on the same side of the shoulder surgery. Each ear has 5 points of puncture by the ASP needles. The points, in sequence of puncture are named: cingulate gyrus, thalamus, omega 2, point zero and shen men. The PA/AI using sterile technique (proper hand washing, PPE) will start with the ipsilateral ear. The subjects ear is cleaned with an alcohol swab, and punctured with the ASP needle in the cingulate gyrus. After waiting for pain attenuation/side effect monitoring, the subject will ambulate in the clinic to reassess their perceived pain. If the subjects' pain is above the desired 0-1/10 VAS level, the contralateral ear will be punctured with the ASP needle in the cingulate gyrus under sterile technique. After waiting for pain attenuation/side effect monitoring, the subject will ambulate in the clinic to reassess their perceived pain. If the subjects' pain is above the desired 0-1/10 VAS level, the ipsilateral ear will be punctured with the ASP needle in the thalamus point under sterile technique. After waiting for pain attenuation/side effect monitoring, the subject will ambulate in the clinic to reassess their perceived pain. This sterile acupuncture process will proceed alternating ears until the dominant ear for pain attenuation is determined (using only the 5 Battlefield Acupuncture points) until the desired 0-1/10 VAS level is achieved. The subject will be constantly monitored for side effects to include light headedness, dizziness/loss of balance or nausea. Depending on the subjects' pain response, the ASP needles may be inserted into one ear predominantly, for greater pain attenuation. The ASP needles may remain in the Subjects' ears for 3-5 days. There is no standard time for the ASP needles to remain in the Subjects' ears. The ASP needles will naturally work their way out of the Subject's skin over 3-5 days. There are no documented cases of loss of treatment effect if the Subject removes the ASP needles premature to their natural falling off.

Control Group: Subjects in this group will receive rehabilitation and will perform a home exercise program in accordance with the post-operative shoulder protocol. Subjects will be asked to record compliance on an exercise log. Handouts will be provided to each subject.

Repeat measurement of VAS, PSFS, GROC, and daily opioid/NSAID/acetaminophen use will be taken by the PI/AI or study staff on day one, 72 hours, 7days, 14 days and at 6weeks.

All study subjects will engage in supervised progression of their respective post-surgical protocols. Subjects will be progressed within their respective protocols at a safe pace, and their home exercise program compliance will be monitored throughout the 6 weeks of this study. At any time, a subject may opt out of the study without detriment in their care at KACH/Arvin Clinic. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03525275
Study type Interventional
Source Keller Army Community Hospital
Contact
Status Completed
Phase N/A
Start date August 15, 2018
Completion date April 15, 2019

See also
  Status Clinical Trial Phase
Completed NCT05480111 - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy Phase 4
Completed NCT06129305 - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed NCT04401826 - Micro-surgical Treatment of Gummy Smile N/A
Recruiting NCT04020133 - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction. N/A
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT03652103 - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy Phase 4
Completed NCT03546738 - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery N/A
Terminated NCT03261193 - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain Phase 3
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Completed NCT02525133 - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty Phase 3
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Enrolling by invitation NCT05316168 - Post Operative Pain Management for ACL Reconstruction Phase 3
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Enrolling by invitation NCT04574791 - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty N/A
Completed NCT04073069 - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults Phase 4
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Recruiting NCT05351229 - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery Phase 4
Enrolling by invitation NCT05543109 - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04919317 - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty Phase 2