Chronic Pain SyndromeSAAAPPNCT04208659
Veteran Ear Acupuncture Pilot Project
A study testing Self-administration of auricular acupuncture without prosthesis and Self-administration of auricular acupuncture with prosthesis in people with Chronic Pain Syndrome and Pain, run by Chillicothe VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain Syndrome, Pain, Fibromyalgia
- What is being tested?
- Self-administration of auricular acupuncture without prosthesis and Self-administration of auricular acupuncture with prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chillicothe VA Medical Center
Chillicothe, Ohio, 45601
About this study
Official title: Self-Administration of Auricular Acupuncture Pilot Project
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.
Read the 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.
- Conditions
- Chronic Pain Syndrome, Pain, Fibromyalgia, Low Back Pain, Neuropathic Pain, Neuropathy, Painful
- Being tested
- Self-administration of auricular acupuncture without prosthesis, Self-administration of auricular acupuncture with prosthesis
- 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
- Medical subject headings
- Pain, Fibromyalgia, Low Back Pain, Neuralgia, Neuropathy, Painful, Musculoskeletal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administration of auricular acupuncture without prosthesisProcedure or surgery
Participants will insert semi-permanent acupuncture needles in their ears without the guidance of a prosthesis
Self-administration of auricular acupuncture with prosthesisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-administration of Auricular Acupuncture Group | Experimental | 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. Receives: Procedure: Self-administration of auricular acupuncture without prosthesis; Procedure: Self-administration of auricular acupuncture with prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start27 Feb 2020
- Primary completion8 Sep 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chillicothe VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Brian L James, MD, Principal investigator, Chillicothe VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208659
- Sponsor's protocol ID
- ChilliVASAAAUC2019-0194
- Acronym
- SAAAPP
- Status last verified
- Dec 2020
- First submitted
- 12 Dec 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data from this small pilot project.
Publications
White, A, Cummings, M, Filshie Jacqueline. An Introduction to Western Medical Acupuncture. Philadelphia, PA: Elsevier; 2008.
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.
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.
PubMed 17076456Niemtzow 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
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.
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.
PubMed 15777857Vas 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.
PubMed 25027493Yeh 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.
PubMed 25165482Hou 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.
PubMed 26823672Chang 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.
PubMed 22844334Fox 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.
PubMed 29550099Jan 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.
PubMed 29067138Lee 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.
PubMed 4055136Stellon 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.
PubMed 14620303Tan 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.
PubMed 25435890
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administration of Auricular Acupuncture Pilot Project
- ClinicalTrials.gov ID
- NCT04208659
- Acronym / sponsor ID
- SAAAPP / ChilliVASAAAUC2019-0194
- Conditions
- Chronic Pain Syndrome, Pain, Fibromyalgia, Low Back Pain, Neuropathic Pain, Neuropathy, Painful
- Keywords
- acupuncture, auricular acupuncture, chronic pain, fibromyalgia, low back pain, lumbago, neuropathic pain, neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Chillicothe VA Medical CenterUS federal agency
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-administration of Auricular Acupuncture Group | Experimental | Procedure: Self-administration of auricular acupuncture without prosthesis, Procedure: Self-administration of auricular acupuncture with prosthesisThere 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administration of auricular acupuncture without prosthesisParticipants will insert semi-permanent acupuncture needles in their ears without the guidance of a prosthesis | Procedure or surgery | Self-administration of Auricular Acupuncture Group |
| Self-administration of auricular acupuncture with prosthesisThe 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. | Procedure or surgery | Self-administration of Auricular Acupuncture Group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Self-Administered Auricular Acupuncture)
Time frame: Six months
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
Time frame: 3 months
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.
1 secondary outcome
Comparative Satisfaction with Pain Control of Self-Administered Auricular Acupuncture versus Previous Episodes of Provider Administered Auricular Acupuncture
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- BackgroundWhite, A, Cummings, M, Filshie Jacqueline. An Introduction to Western Medical Acupuncture. Philadelphia, PA: Elsevier; 2008.
- BackgroundAlimi D, MD, Geissmann A, MD, Gardeur D, MD. Auricular Acupuncture Stimulation Measured on Functional Magnetic Resonance Imaging, Medical Acupuncture. 2002:13(2);18-21.
- Background: PubMed 17076456Goertz 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.
- BackgroundNiemtzow 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
- BackgroundBurns 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.
- Background: PubMed 15777857Usichenko 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.
- Background: PubMed 25027493Vas 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.
- Background: PubMed 25165482Yeh 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.
- Background: PubMed 26823672Hou 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.
- Background: PubMed 22844334Chang 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.
- Background: PubMed 29550099Fox 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.
- Background: PubMed 29067138Jan 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data from this small pilot project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian L James, MD principal investigator
Chillicothe VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administration of auricular acupuncture without prosthesis and Self-administration of auricular acupuncture with prosthesis in people with Chronic Pain Syndrome and Pain, run by Chillicothe VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Self-Administered Auricular Acupuncture) (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208659, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.