Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone After Shoulder Surgery
Condition: Opioid Use; Pain, Postoperative; SLAP Lesion; Bankart Lesion; Subacromial Impingement Syndrome; Rotator Cuff Tear; Glenohumeral Dislocation; Glenohumeral Subluxation; Hill Sach Lesion; Bony Bankart Lesion; Acromioclavicular Separation
MeSH terms: Shoulder Impingement Syndrome; Shoulder Dislocation; Pain, Postoperative; Rotator Cuff Injuries; Bankart Lesions
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Battlefield Acupuncture; Post-surgical shoulder protocol
Intervention type(s): Device; Procedure
Intervention description(s): Battlefield Acupuncture uses ASP semi-permanent needles inserted into their ears for pain attenuation in 5 known points. Both groups receive their respective post-surgical rehabilitation protocols; Surgery specific post-surgical physical therapy protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 x 5 Mixed model ANOVA
Masking: None (Open Label)
Primary purpose: Treatment