BFA Treatment of Pain

NCT04464954 | Completed Results FDA Device

• 1 other identifier: FWH20200117H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Acute Pain

Keywords

acupuncture; battlefield acupuncture

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

Study Arms (3)

Auricular semi-permanent (ASP gold) needles

EXPERIMENTAL

Device: Auricular semi-permanent (ASP gold) needles

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

EXPERIMENTAL

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

Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

EXPERIMENTAL

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

Interventions

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

Auricular semi-permanent (ASP gold) needles

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.

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

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.

Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active duty and DoD Beneficiaries aged 18 years or older
• Acute (0-4 days) musculoskeletal injury

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul Crawford: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (17)

• Chen YM. Clinical application of lower He-Sea points for abdominal pain [presentation] 28th Annual International Symposium on Acupuncture, Electro-Therapeutics Researches, Columbia University Faculty House, New York, NY, October 27, 2012.

  BACKGROUND

• Melzack, Ronald. Pain Forum. Volume 5 (2). Summer 1996. Pages 128-138.

  BACKGROUND

• Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009 Jan 27;338:a3115. doi: 10.1136/bmj.a3115.

  PMID: 19174438 BACKGROUND

• Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.

  PMID: 29198932 BACKGROUND

• Yuan QL, Wang P, Liu L, Sun F, Cai YS, Wu WT, Ye ML, Ma JT, Xu BB, Zhang YG. Acupuncture for musculoskeletal pain: A meta-analysis and meta-regression of sham-controlled randomized clinical trials. Sci Rep. 2016 Jul 29;6:30675. doi: 10.1038/srep30675.

  PMID: 27471137 BACKGROUND

• Devitt M. Research Finds Acupuncture Effective for Chronic Pain [Internet]. AAFP Home | American Academy of Family Physicians. 2018 [cited 2020Apr1]. Available from: https://www.aafp.org/home. html

  BACKGROUND

• Center for Medicare and Medicaid Services. Decision Summary: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N). Center for Medicare and Medicaid Services. July 15, 2019. https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decisionmemo. aspx?NCAId=295

  BACKGROUND

• Pain management task force final report77. (2010). Office of the Army Surgeon General. Retrieved from http://www.armymedicine.army.mil/reports/Pain_Management_Task_Force.pdf.

  BACKGROUND

• Walker PH, Pock A, Ling CG, Kwon KN, Vaughan M. Battlefield acupuncture: Opening the door for acupuncture in Department of Defense/Veteran's Administration health care. Nurs Outlook. 2016 Sep-Oct;64(5):491-8. doi: 10.1016/j.outlook.2016.07.008. Epub 2016 Jul 20.

  PMID: 27601311 BACKGROUND

• Defense and Veterans Center for Integrative Pain Management.(2016). Retrieved from http://www. dvcipm.org/.

  BACKGROUND

• Spotswood, S. (2014). Auricular acupuncture: Convenient technique for battlefield pain. U.S. Medicine, Retrieved from http://www.usmedicine.com/agencies/department-ofdefense-dod/auricular-acupunctureconvenient- techniquefor-battlefield-pain/.

  BACKGROUND

• Koffman, R., & Helms, M. (2013). Acupuncture and PTSD: 'come for the needles, stay for the therapy'. Psychiatric Annals, 43(5),236e239.

  BACKGROUND

• Crawford P, Penzien DB, Coeytaux R. Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Med Acupunct. 2017 Aug 1;29(4):229-231. doi: 10.1089/acu.2017.1234.

  PMID: 28874924 BACKGROUND

• Niemtzow, R. (2007). Battlefield acupuncture. Medical Acupuncture,19, 225e228.

  BACKGROUND

• DHA-PI 6025.33, Acupuncture Practice in Military Medical Treatment Facilities February 20, 2020. Retrieved from pdf.

  BACKGROUND

• Bonakdar RA, Mills PJ. Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial. United States Naval Medical Center San Diego in collaboration with Scripps Integrative Medical Center at La Jolla, CA. NIH Clinical Trail NCT02263001. Last Updated May 4, 2017.

  BACKGROUND

• Burton SJ, Moss DA, Crawford PF 3rd. Effect of needle selection on battlefield acupuncture tolerance and pain reduction: an exploratory randomized controlled trial. Acupunct Med. 2025 Nov 29:9645284251400386. doi: 10.1177/09645284251400386. Online ahead of print.

  PMID: 41317090 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain; Acute Pain

Interventions

Needles; Injections, Intradermal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Amanda Crawford
• Organization: Mike O'Callaghan Military Medical Center

amanda.j.crawford.ctr@health.mil

7026532067

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 9, 2020
• Study Start: November 1, 2020
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)