Pain, Postoperative Clinical Trial
Official title:
The Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone Following Shoulder Surgery: A Randomized Clinical Trial
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.
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.
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