Clinical trial NCT04208659: Veteran Ear Acupuncture Pilot Project
Official title: Self-Administration of Auricular Acupuncture Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain Syndrome
Pain
Fibromyalgia
Low Back Pain
Neuropathic Pain
Neuropathy, Painful
Musculoskeletal Pain
Chronic Pain
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
Lead sponsor: Chillicothe VA Medical Center
Sponsor class: FED
First posted: 2019-12-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Self-Administered Auricular Acupuncture)
timeFrame: Six months
measure: Incidence of Perceived Improved Ease of Self-administration of Auricular Acupuncture with 3D-printed Ear Prostheses
timeFrame: 3 months
Secondary outcomes:
measure: Comparative Satisfaction with Pain Control of Self-Administered Auricular Acupuncture versus Previous Episodes of Provider Administered Auricular Acupuncture
timeFrame: 6 months
Other outcomes:
Locations:
city: Chillicothe
country: United States
facility: Chillicothe VA Medical Center
state: Ohio
Study officials:
affiliation: Chillicothe VA Medical Center
name: Brian L James, MD
role: PRINCIPAL_INVESTIGATOR
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