Veteran Ear Acupuncture Pilot Project

NCT04208659 | Completed

• 1 other identifier: ChilliVASAAAUC2019-0194
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Veterans who have responded well to Battlefield Acupuncture (BFA), a form of auricular acupuncture, in routine clinical practice will be invited to receive education to insert the needles themselves at home. A 3D-printed wearable prosthetic will also be explored as a means to facilitate needle placement. Primary end-points will include whether adverse events occur over a six-month period and whether the aforementioned prosthesis significantly facilitates needle placement in terms of subjective ease of administration.

Conditions

Chronic Pain Syndrome; Pain; Fibromyalgia; Low Back Pain; Neuropathic Pain; Neuropathy, Painful; Musculoskeletal Pain; Chronic Pain

Keywords

acupuncture; auricular acupuncture; chronic pain; fibromyalgia; low back pain; lumbago; neuropathic pain; neuropathy; self-treatment; musculoskeletal pain; prosthesis-guided acupuncture; device-guided acupuncture; device-facilitated acupuncture

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Self-Administered Auricular Acupuncture)

  The total number of self-reported adverse events other than minor self-limited bleeding (less than 1 mL per episode of acupuncture), dizziness and mild nausea will be recorded for the participants. The absolute number and percentage of participants experiencing adverse events greater than the aforementioned will be reported.

  Six months

• Incidence of Perceived Improved Ease of Self-administration of Auricular Acupuncture with 3D-printed Ear Prostheses

  What percentage of patients affirm that the ear prostheses provided during the study make the self-administration of auricular acupuncture easier to perform? This is a dichotomous "yes/no" question.

  3 months

Secondary Outcomes (1)

• Comparative Satisfaction with Pain Control of Self-Administered Auricular Acupuncture versus Previous Episodes of Provider Administered Auricular Acupuncture

  6 months

Study Arms (1)

Self-administration of Auricular Acupuncture Group

EXPERIMENTAL

There is only one arm in this pilot project, whose purpose is to determine safety of self-administration of Battlefield Acupuncture over a six month period and how well a prosthesis facilitates needle insertion. Five ASP (Aiguille D'acupuncture semi-permanente) needles will be self-inserted into each participant's ear every two weeks according to the standardized acupuncture points in Battlefield Acupuncture.

Procedure: Self-administration of auricular acupuncture without prosthesis; Procedure: Self-administration of auricular acupuncture with prosthesis

Interventions

Self-administration of auricular acupuncture without prosthesis PROCEDURE

Participants will insert semi-permanent acupuncture needles in their ears without the guidance of a prosthesis

Self-administration of Auricular Acupuncture Group

Self-administration of auricular acupuncture with prosthesis PROCEDURE

The same participants who previous self-administered a standardized auricular acupuncture will be given custom-molded prostheses midway through the study to assess how much the prostheses facilitate insertion.

Self-administration of Auricular Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of chronic pain from any etiology
• Participant is physically and cognitively able to self-administer auricular acupuncture. This will be determined by the investigator during the educational sessions.
• Participants taking anti-coagulant or anti-platelet medications will be allowed to participate if they acknowledge an increased risk of bleeding

You may not qualify if:

• Condition causing ongoing immunocompromised state (e.g. overt AIDS, chemotherapy, anti-rejection medications)
• Acquired or congenital defects in the tympanic membrane
• Pregnancy
• Severe cognitive impairment
• Physical disability precluding self-administration of auricular acupuncture
• History of severe vasovagal reaction to acupuncture needling
• History of endocarditis
• History of artificial heart valve
• History of implanted device to support cardiac function
• Participation will be terminated for participants who use the acupuncture needles in any way other than instructed
• Participants will be removed from the study if it is discovered they are using the needles in a manner that is inconsistent with the protocol.

Sponsors & Collaborators

• Chillicothe VA Medical Center: lead

Study Sites (1)

Chillicothe VA Medical Center

Chillicothe, Ohio, 45601, United States

Location

Related Publications (16)

• White, A, Cummings, M, Filshie Jacqueline. An Introduction to Western Medical Acupuncture. Philadelphia, PA: Elsevier; 2008.

  BACKGROUND

• Alimi D, MD, Geissmann A, MD, Gardeur D, MD. Auricular Acupuncture Stimulation Measured on Functional Magnetic Resonance Imaging, Medical Acupuncture. 2002:13(2);18-21.

  BACKGROUND

• Goertz CM, Niemtzow R, Burns SM, Fritts MJ, Crawford CC, Jonas WB. Auricular acupuncture in the treatment of acute pain syndromes: A pilot study. Mil Med. 2006 Oct;171(10):1010-4. doi: 10.7205/milmed.171.10.1010.

  PMID: 17076456 BACKGROUND

• Niemtzow RC, Burns SM, Cooper J, Libretto S, Walter JAG, Baxter J., Acupuncture Clinical Pain Trial in a Military Medical Center: Outcomes, Medical Acupuncture. 2008:20(4); 255-261

  BACKGROUND

• Burns S, York A, Niemtzow RC, Garner BK, Steele N, Walter JAG. Moving Acupuncture to the Front Line of Military Medical Care; A Feasibility Study, Medical Acupuncture. 2013:25(1);48-54.

  BACKGROUND

• Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Pain. 2005 Apr;114(3):320-327. doi: 10.1016/j.pain.2004.08.021.

  PMID: 15777857 BACKGROUND

• Vas J, Aranda-Regules JM, Modesto M, Aguilar I, Baron-Crespo M, Ramos-Monserrat M, Quevedo-Carrasco M, Rivas-Ruiz F. Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial. Trials. 2014 Jul 16;15:288. doi: 10.1186/1745-6215-15-288.

  PMID: 25027493 BACKGROUND

• Yeh CH, Chiang YC, Hoffman SL, Liang Z, Klem ML, Tam WW, Chien LC, Suen LK. Efficacy of auricular therapy for pain management: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:934670. doi: 10.1155/2014/934670. Epub 2014 Jul 23.

  PMID: 25165482 BACKGROUND

• Hou PW, Hsu HC, Lin YW, Tang NY, Cheng CY, Hsieh CL. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. doi: 10.1155/2015/495684. Epub 2015 Dec 28.

  PMID: 26823672 BACKGROUND

• Chang LH, Hsu CH, Jong GP, Ho S, Tsay SL, Lin KC. Auricular acupressure for managing postoperative pain and knee motion in patients with total knee replacement: a randomized sham control study. Evid Based Complement Alternat Med. 2012;2012:528452. doi: 10.1155/2012/528452. Epub 2012 Jul 10.

  PMID: 22844334 BACKGROUND

• Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency department. Am J Emerg Med. 2018 Jun;36(6):1045-1048. doi: 10.1016/j.ajem.2018.02.038. Epub 2018 Feb 27.

  PMID: 29550099 BACKGROUND

• Jan AL, Aldridge ES, Rogers IR, Visser EJ, Bulsara MK, Niemtzow RC. Does Ear Acupuncture Have a Role for Pain Relief in the Emergency Setting? A Systematic Review and Meta-Analysis. Med Acupunct. 2017 Oct 1;29(5):276-289. doi: 10.1089/acu.2017.1237.

  PMID: 29067138 BACKGROUND

• Lee RJ, McIlwain JC. Subacute bacterial endocarditis following ear acupuncture. Int J Cardiol. 1985 Jan;7(1):62-3. doi: 10.1016/0167-5273(85)90175-5.

  PMID: 4055136 BACKGROUND

• Stellon A. Acupuncture in patients with valvular heart disease and prosthetic valves. Acupunct Med. 2003 Sep;21(3):87-91. doi: 10.1136/aim.21.3.87.

  PMID: 14620303 BACKGROUND

• Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.

  PMID: 25435890 BACKGROUND

• James BL, Welch J, Williamson C. Self-Administration of Auricular Acupuncture in Rural Veterans with Chronic Pain: A Pilot Project. Med Acupunct. 2021 Oct 1;33(5):349-352. doi: 10.1089/acu.2021.0007. Epub 2021 Oct 18.

  PMID: 35003503 DERIVED

MeSH Terms

Conditions

Pain; Fibromyalgia; Low Back Pain; Neuralgia; Neuropathy, Painful; Musculoskeletal Pain; Chronic Pain

Interventions

Prostheses and Implants

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Peripheral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Brian L James, MD

  Chillicothe VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a pilot project to assess safety of self-administration of auricular acupuncture over a six-month period and how well a custom prosthesis facilitates needle placement.

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 23, 2019
• Study Start: February 27, 2020
• Primary Completion: September 8, 2020
• Study Completion: July 1, 2021
• Last Updated: November 1, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)