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Veteran Ear Acupuncture Pilot Project (SAAAPP)

Primary Purpose

Chronic Pain Syndrome, Pain, Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Self-administration of auricular acupuncture without prosthesis

Self-administration of auricular acupuncture with prosthesis

About this trial

This is an interventional other trial for Chronic Pain Syndrome focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Chillicothe VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-administration of Auricular Acupuncture Group

Arm Description

There is only one arm in this pilot project, whose purpose is to determine safety of self-administration of Battlefield Acupuncture over a six month period and how well a prosthesis facilitates needle insertion. Five ASP (Aiguille D'acupuncture semi-permanente) needles will be self-inserted into each participant's ear every two weeks according to the standardized acupuncture points in Battlefield Acupuncture.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (Self-Administered Auricular Acupuncture)

The total number of self-reported adverse events other than minor self-limited bleeding (less than 1 mL per episode of acupuncture), dizziness and mild nausea will be recorded for the participants. The absolute number and percentage of participants experiencing adverse events greater than the aforementioned will be reported.

Incidence of Perceived Improved Ease of Self-administration of Auricular Acupuncture with 3D-printed Ear Prostheses

What percentage of patients affirm that the ear prostheses provided during the study make the self-administration of auricular acupuncture easier to perform? This is a dichotomous "yes/no" question.

Secondary Outcome Measures

Comparative Satisfaction with Pain Control of Self-Administered Auricular Acupuncture versus Previous Episodes of Provider Administered Auricular Acupuncture

Previous provider-administered post-needling auricular acupuncture pain scores as measured by the Numeric Rating Scale will be averaged for each participant according to the availability of such data. All participants will be expected to have several such data points in the electronic medical record. These scores will be averaged for each patient. This individual average will be compared to the average of post-needling NRS scores reported from the self-administration of auricular acupuncture for the same patient. The percentage of difference in the NRS score between provider-administered and self-administered acupuncture will be reported to assess for possible non-inferiority of self-administered auricular acupuncture.

Full Information

NCT ID

NCT04208659

First Posted

December 12, 2019

Last Updated

October 28, 2021

Sponsor

Chillicothe VA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04208659

Brief Title

Veteran Ear Acupuncture Pilot Project

Acronym

SAAAPP

Official Title

Self-Administration of Auricular Acupuncture Pilot Project

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

February 27, 2020 (Actual)

Primary Completion Date

September 8, 2020 (Actual)

Study Completion Date

July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chillicothe VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Self-administration of Auricular Acupuncture Group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Self-administration of auricular acupuncture without prosthesis

Intervention Description

Participants will insert semi-permanent acupuncture needles in their ears without the guidance of a prosthesis

Intervention Type

Procedure

Intervention Name(s)

Self-administration of auricular acupuncture with prosthesis

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events (Self-Administered Auricular Acupuncture)

Description

Time Frame

Six months

Title

Incidence of Perceived Improved Ease of Self-administration of Auricular Acupuncture with 3D-printed Ear Prostheses

Description

What percentage of patients affirm that the ear prostheses provided during the study make the self-administration of auricular acupuncture easier to perform? This is a dichotomous "yes/no" question.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Comparative Satisfaction with Pain Control of Self-Administered Auricular Acupuncture versus Previous Episodes of Provider Administered Auricular Acupuncture

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian L James, MD

Organizational Affiliation

Chillicothe VA Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chillicothe VA Medical Center

City

Chillicothe

State/Province

Ohio

ZIP/Postal Code

45601

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share individual participant data from this small pilot project.

Citations:

Citation

White, A, Cummings, M, Filshie Jacqueline. An Introduction to Western Medical Acupuncture. Philadelphia, PA: Elsevier; 2008.

Results Reference

background

Citation

Alimi D, MD, Geissmann A, MD, Gardeur D, MD. Auricular Acupuncture Stimulation Measured on Functional Magnetic Resonance Imaging, Medical Acupuncture. 2002:13(2);18-21.

Results Reference

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PubMed Identifier

17076456

Citation

Goertz CM, Niemtzow R, Burns SM, Fritts MJ, Crawford CC, Jonas WB. Auricular acupuncture in the treatment of acute pain syndromes: A pilot study. Mil Med. 2006 Oct;171(10):1010-4. doi: 10.7205/milmed.171.10.1010.

Results Reference

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Citation

Niemtzow RC, Burns SM, Cooper J, Libretto S, Walter JAG, Baxter J., Acupuncture Clinical Pain Trial in a Military Medical Center: Outcomes, Medical Acupuncture. 2008:20(4); 255-261

Results Reference

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Citation

Burns S, York A, Niemtzow RC, Garner BK, Steele N, Walter JAG. Moving Acupuncture to the Front Line of Military Medical Care; A Feasibility Study, Medical Acupuncture. 2013:25(1);48-54.

Results Reference

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PubMed Identifier

15777857

Citation

Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Pain. 2005 Apr;114(3):320-327. doi: 10.1016/j.pain.2004.08.021.

Results Reference

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PubMed Identifier

25027493

Citation

Vas J, Aranda-Regules JM, Modesto M, Aguilar I, Baron-Crespo M, Ramos-Monserrat M, Quevedo-Carrasco M, Rivas-Ruiz F. Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial. Trials. 2014 Jul 16;15:288. doi: 10.1186/1745-6215-15-288.

Results Reference

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PubMed Identifier

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Citation

Yeh CH, Chiang YC, Hoffman SL, Liang Z, Klem ML, Tam WW, Chien LC, Suen LK. Efficacy of auricular therapy for pain management: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:934670. doi: 10.1155/2014/934670. Epub 2014 Jul 23.

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Citation

Hou PW, Hsu HC, Lin YW, Tang NY, Cheng CY, Hsieh CL. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. doi: 10.1155/2015/495684. Epub 2015 Dec 28.

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PubMed Identifier

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Citation

Chang LH, Hsu CH, Jong GP, Ho S, Tsay SL, Lin KC. Auricular acupressure for managing postoperative pain and knee motion in patients with total knee replacement: a randomized sham control study. Evid Based Complement Alternat Med. 2012;2012:528452. doi: 10.1155/2012/528452. Epub 2012 Jul 10.

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PubMed Identifier

29550099

Citation

Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency department. Am J Emerg Med. 2018 Jun;36(6):1045-1048. doi: 10.1016/j.ajem.2018.02.038. Epub 2018 Feb 27.

Results Reference

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PubMed Identifier

29067138

Citation

Jan AL, Aldridge ES, Rogers IR, Visser EJ, Bulsara MK, Niemtzow RC. Does Ear Acupuncture Have a Role for Pain Relief in the Emergency Setting? A Systematic Review and Meta-Analysis. Med Acupunct. 2017 Oct 1;29(5):276-289. doi: 10.1089/acu.2017.1237.

Results Reference

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PubMed Identifier

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Citation

Lee RJ, McIlwain JC. Subacute bacterial endocarditis following ear acupuncture. Int J Cardiol. 1985 Jan;7(1):62-3. doi: 10.1016/0167-5273(85)90175-5.

Results Reference

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PubMed Identifier

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Citation

Stellon A. Acupuncture in patients with valvular heart disease and prosthetic valves. Acupunct Med. 2003 Sep;21(3):87-91. doi: 10.1136/aim.21.3.87.

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PubMed Identifier

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Citation

Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.

Results Reference

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PubMed Identifier

35003503

Citation

James BL, Welch J, Williamson C. Self-Administration of Auricular Acupuncture in Rural Veterans with Chronic Pain: A Pilot Project. Med Acupunct. 2021 Oct 1;33(5):349-352. doi: 10.1089/acu.2021.0007. Epub 2021 Oct 18.

Results Reference

derived

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Veteran Ear Acupuncture Pilot Project

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