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Veteran Ear Acupuncture Pilot Project (SAAAPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208659
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Chillicothe VA Medical Center

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Syndrome Pain Fibromyalgia Low Back Pain Neuropathic Pain Neuropathy, Painful Musculoskeletal Pain Chronic Pain Procedure: Self-administration of auricular acupuncture without prosthesis Procedure: Self-administration of auricular acupuncture with prosthesis Not Applicable

Detailed Description:

30 veterans who have repeatedly had good responses to BFA will be invited to participate. The PI and his collaborators will give standardized education (BFA training) to the veterans in a group session to teach them how to self-administer the BFA. The BFA training will be identical to that used by the VA for providers except that the training will focus on self-administration. The participants will be given needles in a manner similar to a prescription medication (i.e. controlled by the provider). They will self-administer BFA every two weeks for a total of 6 months and record their response in a standardized BFA template. Providers will call participants at intervals of two to four weeks to retrieve this data and assess for any adverse events other than minor bleeding, scratches and dizziness.

A plastic, custom-molded prosthesis will be developed during the first several months using 3D-scanning and 3D-printing. This prosthesis will be wearable over the ear and will have holes directly over the relevant acupuncture points to facilitate insertion. At the 3-month mark, participants will be given these. If this turns out to not be feasible with the available resources, work on this will cease for the remainder of the project. At the end of the study, participants will be asked whether the prosthesis made a significant difference in the ease of administration and open-ended comments regarding their experience will also be solicited.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Self-Administration of Auricular Acupuncture Pilot Project
Estimated Study Start Date : January 9, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-administration of Auricular Acupuncture Group
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
Participants will insert semi-permanent acupuncture needles in their ears without the guidance of a prosthesis

Procedure: Self-administration of auricular acupuncture with 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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Self-Administered Auricular Acupuncture) [ Time Frame: Six months ]
    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.

  2. Incidence of Perceived Improved Ease of Self-administration of Auricular Acupuncture with 3D-printed Ear Prostheses [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Comparative Satisfaction with Pain Control of Self-Administered Auricular Acupuncture versus Previous Episodes of Provider Administered Auricular Acupuncture [ Time Frame: 6 months ]
    Previous provider-administered post-needling auricular acupuncture pain scores as measured by the Numeric Rating Scale will be averaged for each participant according to the availability of such data. All participants will be expected to have several such data points in the electronic medical record. These scores will be averaged for each patient. This individual average will be compared to the average of post-needling NRS scores reported from the self-administration of auricular acupuncture for the same patient. The percentage of difference in the NRS score between provider-administered and self-administered acupuncture will be reported to assess for possible non-inferiority of self-administered auricular acupuncture.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Exclusion criteria include those who do not wish to participate and those who have significant contraindications to AA (auricular acupuncture) or indwelling acupuncture. These include: being immunocompromised, congenital or acquired defects in the tympanic membrane, pregnancy, severe cognitive impairment, inability to perform BFA on themselves. Medical anti-coagulation is not an automatic exclusion as many patients on these medications will not have any issues with bleeding with BFA. Those who have history of severe vasovagal/syncopal or other adverse response to skin puncture will also be excluded. Those with artificial heart valves or those with a history of heart valve infection are excluded because of risk of endocarditis. Pregnant patients will be excluded from this study to eliminate the possibility of harm to pregnant patients and developing children. Medical conditions that would exclude someone from using BFA include: 1) those with replacement heart valves; 2) those with history of heart valve infection; 3) those who are pregnant; 4) those who have a pacemaker, defibrillator, or other similar electronic device; 5) those who are afraid of needles, 6) those who are scheduled for an MRI; 7) those with non-medication induced bleeding disorders.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208659


Locations
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United States, Ohio
Chillicothe VA Medical Center
Chillicothe, Ohio, United States, 45601
Sponsors and Collaborators
Chillicothe VA Medical Center
Investigators
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Principal Investigator: Brian L James, MD Chillicothe VA Medical Center

Publications:
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.
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.

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Responsible Party: Chillicothe VA Medical Center
ClinicalTrials.gov Identifier: NCT04208659    
Other Study ID Numbers: ChilliVASAAAUC2019-0194
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data from this small pilot project.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chillicothe VA Medical Center:
acupuncture
auricular acupuncture
prosthesis-guided acupuncture
device-guided acupuncture
device-facilitated acupuncture
chronic pain
fibromyalgia
low back pain
lumbago
neuropathic pain
neuropathy
self-treatment
musculoskeletal pain
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Musculoskeletal Pain
Neuralgia
Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Peripheral Nervous System Diseases