BFA Treatment of Pain

April 2, 2024 updated by: Paul Crawford

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Nellis Air Force Base, Nevada, United States, 89191
        • Mike O'Callaghan Military Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

**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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture)
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.
average pain at needle site 1-week post insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Crawford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

April 20, 2021

Study Completion (Actual)

April 20, 2021

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20200117H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan on sharing data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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