BFA Treatment of Pain

Not Applicable

Completed

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

• Registration Number: NCT04464954
• Lead Sponsor: Paul Crawford

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Study Start: 2020-11-01
• Primary Completion: 2021-04-20
• Study Completion: 2021-04-20
• Results First Submitted: 2023-08-11
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Results First Posted: 2024-04-04
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular semi-permanent (ASP gold) needles	Auricular semi-permanent (ASP gold) needles	-
Pyonex needles (Seirin Yellow 0.2 x 0.6mm)	Pyonex needles (Seirin Yellow 0.2 x 0.6mm)	-
Intradermal (long) needles using J-type No. 2 (.18)x 15mm	Intradermal (long) needles using J-type No. 2 (.18)x 15mm	-

Primary Outcome Measures

Name	Time	Method
Effectiveness: Scale	repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture)	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.
Needle Tolerance: Questionnaire	average pain at needle site 1-week post insertion	Measured using an in-house developed questionnaire. It employed a 5-point (1-5) ordinal scale to evaluate pain at needle site. Lower score (1) is no pain. Higher score (5) is constant pain.

Trial Locations

Locations (1)

Mike O'Callaghan Military Medical Center; 🇺🇸 Nellis Air Force Base, Nevada, United States