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Completed

NCT Number: NCT04464954

BFA Treatment of Pain

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.

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Key information

Conditions

Musculoskeletal Pain Acute Pain Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**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

Treatment and study plan

Auricular semi-permanent (ASP gold) needles

Device

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

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

Device

Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.

Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

Device

Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.

Primary outcomes

  1. Effectiveness: Scale

    Time frame: 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.

  2. Needle Tolerance: Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Paul Crawford

Fed

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2020
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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