MastectomyATMAGDNCT05126615
Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)
A study testing Auriculotherapy and Chronic Post-Surgical Pain evaluation in people with Mastectomy and Auriculotherapy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Over the past decade, more and more healthcare professionals are using auriculotherapy as a preventative and effective therapy for pain. This therapy is applied by odontologists, anesthetists, surgeons, etc., to alleviate chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Auriculotherapy
- What is being tested?
- Auriculotherapy and Chronic Post-Surgical Pain evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2019to 17 Sep 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women patient over 18 years-old
- Patient scheduled for a mastectomy with immediate reconstruction by latissimus dorsi flap with or without symmetrization on the contralateral breast.
- Patient affiliated or beneficiary of a social security scheme.
- Patient who has given her free and informed consent.
- Preoperative blood test showing no contraindication to the operation.
Who cannot join
- Refusal of the patient.
- No indication for auriculotherapy:
- Patient having a heavy treatment with neuroleptics,
- Or tricyclic antidepressants which interfere with the action of auriculotherapy.
- Patient undergoing long-term morphine treatment for chronic pain.
- Patient with unweaned opioid addiction.
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- Chronic painful patient.
- Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent.
- Pregnant, breastfeeding or parturient woman.
- Patient participating in another interventional study.
- Patient who had already participated in this study as part of first breast surgery.
- Patient receiving regular care by auriculotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Over the past decade, more and more healthcare professionals are using auriculotherapy as a preventative and effective therapy for pain. This therapy is applied by odontologists, anesthetists, surgeons, etc., to alleviate chronic pain. The effects of auriculotherapy are known in particular in reducing preoperative anxiety, pain in cancer patients and postoperative pain.
The aim of this study is to assess the effectiveness of adding auriculotherapy to the standard global anesthetic protocol, compared to this single reference protocol, on the incidence at 3 months post-intervention of Chronic Post-Surgical Pain, in patients operated for a mastectomy with reconstruction immediate by latissimus dorsi flap.
- Conditions
- Mastectomy, Auriculotherapy
- Being tested
- Auriculotherapy, Chronic Post-Surgical Pain evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuriculotherapyDrug
Application of a bolus of 5 μ of liquid nitrogen via a cryospray on the auriculotherapy points A4, C18, D9, C9, DIX, H13, G14 and FXVII, chosen according to a neurophysiological reasoning taking into account the surgical intervention performed and innervation of the anatomical region affected by the intervention.
Chronic Post-Surgical Pain evaluationBehavioural
Different questionnaires :
BPI : Brief Pain Inventory DN4
| Study group | Role | What they receive |
|---|---|---|
| Patients with auriculotherapy | Experimental | Mastectomy operated patient then, auriculotherapy Receives: Drug: Auriculotherapy; Behavioral: Chronic Post-Surgical Pain evaluation |
| Patient with placebo | Placebo comparator | Mastectomy operated patient then, they received placebo Receives: Behavioral: Chronic Post-Surgical Pain evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence, or not, of Chronic Post-Surgical Pain (DCPC)
DCPC noted during the clinical examination of the 3rd postoperative month :
- score obtained at BPI : Brief Pain Inventory (9 items : many items with answers between 0 and 10)
Measured: 3 months
Presence, or not, of Chronic Post-Surgical Pain (DCPC)
DCPC noted during the clinical examination of the 3rd postoperative month :
- score obtained at DN4 (neuropathic pain) : 4 different items
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start10 May 2019
- Primary completion6 Aug 2021
- Study completion17 Sep 2021
Why it stopped: difficulty of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126615
- Sponsor's protocol ID
- 2018-A01108-47
- Acronym
- ATMAGD
- Status last verified
- Jul 2026
- First submitted
- 9 Nov 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)
- ClinicalTrials.gov ID
- NCT05126615
- Acronym / sponsor ID
- ATMAGD / 2018-A01108-47
- Conditions
- Mastectomy, Auriculotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty of recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 19 Nov 2021 (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.
Over the past decade, more and more healthcare professionals are using auriculotherapy as a preventative and effective therapy for pain. This therapy is applied by odontologists, anesthetists, surgeons, etc., to alleviate chronic pain. The effects of auriculotherapy are known in particular in reducing preoperative anxiety, pain in cancer patients and postoperative pain.
The aim of this study is to assess the effectiveness of adding auriculotherapy to the standard global anesthetic protocol, compared to this single reference protocol, on the incidence at 3 months post-intervention of Chronic Post-Surgical Pain, in patients operated for a mastectomy with reconstruction immediate by latissimus dorsi flap.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with auriculotherapy | Experimental | Drug: Auriculotherapy, Behavioral: Chronic Post-Surgical Pain evaluationMastectomy operated patient then, auriculotherapy |
| Patient with placebo | Placebo comparator | Behavioral: Chronic Post-Surgical Pain evaluationMastectomy operated patient then, they received placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women patient over 18 years-old
- Patient scheduled for a mastectomy with immediate reconstruction by latissimus dorsi flap with or without symmetrization on the contralateral breast.
- Patient affiliated or beneficiary of a social security scheme.
- Patient who has given her free and informed consent.
- Preoperative blood test showing no contraindication to the operation.
Key exclusion criteria (12 listed)
- Refusal of the patient.
- No indication for auriculotherapy:
- Patient having a heavy treatment with neuroleptics,
- Or tricyclic antidepressants which interfere with the action of auriculotherapy.
- Patient undergoing long-term morphine treatment for chronic pain.
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 |
|---|---|---|
| AuriculotherapyApplication of a bolus of 5 μ of liquid nitrogen via a cryospray on the auriculotherapy points A4, C18, D9, C9, DIX, H13, G14 and FXVII, chosen according to a neurophysiological reasoning taking into account the surgical intervention performed and innervation of the anatomical region affected by the intervention. | Drug | Patients with auriculotherapy |
| Chronic Post-Surgical Pain evaluationDifferent questionnaires : BPI : Brief Pain Inventory DN4 | Behavioural | Patient with placebo, Patients with auriculotherapy |
Primary outcome
Presence, or not, of Chronic Post-Surgical Pain (DCPC)
Time frame: 3 months
DCPC noted during the clinical examination of the 3rd postoperative month : - score obtained at BPI : Brief Pain Inventory (9 items : many items with answers between 0 and 10)
Presence, or not, of Chronic Post-Surgical Pain (DCPC)
Time frame: 3 months
DCPC noted during the clinical examination of the 3rd postoperative month : - score obtained at DN4 (neuropathic pain) : 4 different items
Results and safety
The study was stopped early (reason given: difficulty of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auriculotherapy and Chronic Post-Surgical Pain evaluation in people with Mastectomy and Auriculotherapy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 5 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: stopped early, as of the sponsor's last update on 16 Jul 2026. 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 France. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: difficulty of recruitment). Results are not available in the source record.
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?
Presence, or not, of Chronic Post-Surgical Pain (DCPC) (time frame: 3 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?
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 16 Jul 2026.