NCT04208659

Veteran Ear Acupuncture Pilot Project

Self-Administration of Auricular Acupuncture Pilot Project

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Chillicothe VA Medical Center · Federal
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-27
• Primary completion: 2020-09-08
• Completion: 2021-07-01
• First posted: 2019-12-23
• Last updated: 2021-11-01

Locations

1 site across 1 country: United States