Veteran Ear Acupuncture Pilot Project
Condition: Chronic Pain Syndrome; Pain; Fibromyalgia; Low Back Pain; Neuropathic Pain; Neuropathy, Painful; Musculoskeletal Pain; Chronic Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Musculoskeletal Pain; Neuralgia; Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): Self-administration of auricular acupuncture without prosthesis; Self-administration of auricular acupuncture with prosthesis
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants will insert semi-permanent acupuncture needles in their ears without the guidance of a 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.
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
Keywords: acupuncture; auricular acupuncture; chronic pain; fibromyalgia; low back pain; lumbago; neuropathic pain; neuropathy; self-treatment; musculoskeletal pain; prosthesis-guided acupuncture; device-guided acupuncture; device-facilitated acupuncture