NCT04208659|Completed
Veteran Ear Acupuncture Pilot Project
SAAAPP
Self-Administration of Auricular Acupuncture Pilot Project
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SAAAPP
Self-Administration of Auricular Acupuncture Pilot Project
Sponsor study identifier
interventional
12
1 country
1
Study Start
February 27, 2020
Actual (reported)Primary Completion
September 8, 2020
Actual (reported)Study Completion
July 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2019
Actual (reported)December 23, 2019
Actual (reported)February 27, 2020
Actual (reported)September 8, 2020
Actual (reported)July 1, 2021
Actual (reported)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
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.
Participants will insert semi-permanent acupuncture needles in their ears without the guidance of a prosthesis
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.
Chillicothe VA Medical Center
Chillicothe, Ohio, 45601, United States
White, A, Cummings, M, Filshie Jacqueline. An Introduction to Western Medical Acupuncture. Philadelphia, PA: Elsevier; 2008.
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.
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.
Brian L James, MD
Chillicothe VA Medical Center
12 participants (actual enrollment reported by the registry).
First Submitted
December 12, 2019
First Posted
December 23, 2019
Study Start
February 27, 2020
Actual (reported)BFA Treatment of Pain
Comparative Satisfaction with Pain Control of Self-Administered Auricular Acupuncture versus Previous Episodes of Provider Administered Auricular Acupuncture
6 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
September 8, 2020
Actual (reported)Study Completion
July 1, 2021
Actual (reported)Last Updated
November 1, 2021
Record last verified: 2020-12
There is no plan to share individual participant data from this small pilot project.
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Source: ClinicalTrials.gov.
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