Veteran Ear Acupuncture Pilot Project
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Pain
- Chronic Pain Syndrome
- Fibromyalgia
- Low Back Pain
- Musculoskeletal Pain
- Neuropathic Pain
- Neuropathy, Painful
- Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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
Participation Requirements
- Age
- Between 18 years and 120 years
- Gender
- Both males and females
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 t...
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.
Tracking Information
- NCT #
- NCT04208659
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Brian L James, MD Chillicothe VA Medical Center
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