BFA Treatment of Pain

Paul Crawford

Status: Completed

Conditions: Musculoskeletal Pain; Acute Pain

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04464954

FWH20200117H

Details and patient eligibility

About

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.

Full description

1. Begin to identify which of 3 needles is most efficacious for BFA treatment of pain;
2. 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

**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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Auricular semi-permanent (ASP gold) needles

Experimental group

Treatment:

Device: Auricular semi-permanent (ASP gold) needles

Intradermal (long) needles using J-type No. 2 (.18)x 15mm

Experimental group

Treatment:

Device: Intradermal (long) needles using J-type No. 2 (.18)x 15mm

Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

Experimental group

Treatment:

Device: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)