Veteran Ear Acupuncture Pilot Project (SAAAPP)

October 28, 2021 updated by: Chillicothe VA Medical Center

Self-Administration of Auricular Acupuncture Pilot Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

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
    • Ohio
      • Chillicothe, Ohio, United States, 45601
        • Chillicothe VA 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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

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

Sponsor

Chillicothe VA Medical Center

Investigators

  • Principal Investigator: Brian L James, MD, Chillicothe VA Medical Center

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)

February 27, 2020

Primary Completion (Actual)

September 8, 2020

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChilliVASAAAUC2019-0194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share individual participant data from this small pilot project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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