BFA Treatment of Pain

Study Overview
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Brief Summary
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The aim of this pilot study is to conduct an unblinded pilot randomized clinical study on the effectiveness and tolerability of auricular semi-permanent (ASP) vs intradermal (long), and pyonex needles in Battlefield Acupuncture (BFA) for the treatment of pain.

Detailed Description
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Begin to identify which of 3 needles is most efficacious for BFA treatment of pain; Identify patient experiences and tolerance of three commonly used acupuncture needles at Mike O'Callaghan Military Medical Center at Nellis Air Force Base. This study will compare 30 patients (10 per needling group) and will serve as a pilot study for a potential larger randomized control trial (RCT) across multiple MTFs in the Defense Health Agency (DHA) to establish better BFA care practices. We will be recruiting a total of 39 subjects, which is inclusive of a 30% drop out rate to accommodate those that may be lost to the study or have missing data to achieve a final total of 30 subjects.

Official Title
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Pilot Study: Effect of Battlefield Acupuncture Needle Selection on Symptom Relief and Patient Tolerance in the Treatment of Pain

Conditions
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Musculoskeletal Pain, Acute Pain

Intervention / Treatment
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* Device: Auricular semi-permanent (ASP gold) needles
* Device: Intradermal (long) needles using J-type No. 2 (.18)x 15mm
* Device: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)


Participation Criteria
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Eligibility Criteria
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**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study** Inclusion Criteria: Active duty and DoD Beneficiaries aged 18 years or older Acute (0-4 days) musculoskeletal injury Injuries eligible for inclusion include all acute non-fracture related musculoskeletal injuries of the axial or peripheral skeleton. Exclusion Criteria: Taking any opioid medications daily Rheumatologic and autoimmune conditions which may be creating pain, such as rheumatoid arthritis, advanced osteoarthritis, or spinal stenosis Contra-indication to needle use including known bleeding disorder and psychogenic issues related to needle use (e.g., needle-phobia) Evidence or history of clinically significant immune deficiency, hematological, oncological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or severe allergic disease (including to metals and adhesive tapes) which could interfere with this study Individuals with progressive radiating pain with motor-sensory changes (including weakness or numbness) related to their presenting pain complaint Women who are pregnant, may be pregnant, or attempting to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular semi-permanent (ASP gold) needles<br> | Device: Auricular semi-permanent (ASP gold) needles<br>* ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own<br>|
| Experimental: Intradermal (long) needles using J-type No. 2 (.18)x 15mm<br> | Device: Intradermal (long) needles using J-type No. 2 (.18)x 15mm<br>* Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.<br>|
| Experimental: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)<br> | Device: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)<br>* Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: scale | Defense and Veterans Pain Rating Scale (DVPRS).DVPRS is an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS demonstrates linear scale qualities allowing parametric methods to be used. | Four repeated measurements of change in the DVRPS: preacupuncture (Day 0), post-acupuncture (10-15 minutes post needle insertion), 24 hours and one week post-therapy. | 
| Needle Tolerance: questionnaire | Will be measured using an in-house developed questionnaire. It employs 5-point ordinal scales to evaluate 12 post-therapy experiences or perception encompassing adverse outcomes, inconveniences, and satisfaction | Three repeated measurements of change in needle tolerance: post-acupuncture (10-15 minutes post needle insertion), 24 hours and 1 week posttherapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, battlefield acupuncture