Veteran Ear Acupuncture Pilot Project
NCT04208659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2021-11-01
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
Interventions
- 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.
Sponsors & Collaborators
-
Chillicothe VA Medical Center
lead FED
Principal Investigators
-
Brian L James, MD · Chillicothe VA Medical Center
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-02-27
- Primary Completion
- 2020-09-08
- Completion
- 2021-07-01
Countries
- United States
Study Locations
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