Musculoskeletal PainTRIPLE-ANCT03096041
Phase 3 Study Randomized Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors
A study testing Auriculotherapy for analgesic use in people with Musculoskeletal Pain and Breast Cancer, run by Centre Francois Baclesse at 7 sites in France.
Trial summary
Auriculotherapy is a complementary medicine, with few side effects, without contraindication, inexpensive and not very restrictive.Its efficacy has been found in several tests especially for the treatment of intraoperative pain. It remains more controversial in other indications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Musculoskeletal Pain, Breast Cancer
- What is being tested?
- Auriculotherapy for analgesic use
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 7 sitesFrance
- Study dates
- 5 Jul 2017to 7 Jul 2025
- 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
- Patient over 18 years of age
- Patients with anti-aromatases in adjuvant treatment of breast cancer
- Menopausal women
- Treatment with aromatase inhibitors (anti-aromatase, AA) initiated for more than 3 months. In the case of a change in anti-aromatase, the last treatment must be started for more than 3 months.
- Musculoskeletal pain appearing or increased under AA:
- Overall pain score of QCD ≥3 (on a scale of 0 to 10)
Show all 13Show fewer
- Pain on at least 2 sites
- Pain for at least 3 months
- History of radiotherapy and / or adjuvant chemotherapy authorized
- Patients may have received tamoxifen
- Patient affiliated to a social security system
- Patient mastering the French language and able to complete the evaluation questionnaires
- Free and Informed Consent
Who cannot join
- Patients who have already undergone treatment in auriculotherapy for the same indication
- Patient benefiting at the same time from a PNCAVT (acupuncture or homeopathy) for musculoskeletal pain
- Wearing hearing aids hindering the placement of semi-permanent needles (ASP)
- Wearing of a valve prosthesis
- Patient under guardianship or unable to give informed consent
- Patient unable to undergo medical follow-up for geographical, social or psychopathological reasons
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre François Baclesse
Caen, 14000
Hôpital Privé Paul d'Egine
Champigny-sur-Marne
Hôpital Cognac-Jay - Forcilles
Férolles-Attilly
CHU Grenoble
Grenoble
Centre Oscar Lambret
Lille
Groupe Hospitalier Paris St Joseph
Paris
IGR
Villejuif
About this study
Official title: Phase 3 Study Randomized Against Placebo, Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors in Adjuvant Treatment of Breast Cancer (TRIPLE-A)
Auriculotherapy is a complementary medicine, with few side effects, without contraindication, inexpensive and not very restrictive.Its efficacy has been found in several tests especially for the treatment of intraoperative pain. It remains more controversial in other indications. Evaluation of the value of auriculotherapy is often difficult because of the methodological limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed to improve the articular pains of patients treated by AA. This Phase III study aims at validate this approach.
- Conditions
- Musculoskeletal Pain, Breast Cancer
- Being tested
- Auriculotherapy for analgesic use, Placebo auriculotherapy
- Keywords
- auriculotherapy, aromatase inhibitors, adjuvant treatment
- Medical subject headings
- Musculoskeletal Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auriculotherapy for analgesic useDevice
The ASP will be applied to specific pain points
Placebo auriculotherapyDevice
The ASP will be applied to placebo points (not specific to pain)
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Auriculotherapy for analgesic use Receives: Device: Auriculotherapy for analgesic use |
| Controle arm | Placebo comparator | Placebo auriculotherapy Receives: Device: Placebo auriculotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the overall pain score
The proportion of patients with a 2-point or greater decrease in the overall pain
Measured: 3 months after auriculotherapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start5 Jul 2017
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096041
- Sponsor's protocol ID
- TRIPLE-A
- Acronym
- TRIPLE-A
- Status last verified
- Sep 2025
- First submitted
- 20 Mar 2017
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study Randomized Against Placebo, Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors in Adjuvant Treatment of Breast Cancer (TRIPLE-A)
- ClinicalTrials.gov ID
- NCT03096041
- Acronym / sponsor ID
- TRIPLE-A / TRIPLE-A
- Conditions
- Musculoskeletal Pain, Breast Cancer
- Keywords
- auriculotherapy, aromatase inhibitors, adjuvant treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 30 Mar 2017 (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.
Auriculotherapy is a complementary medicine, with few side effects, without contraindication, inexpensive and not very restrictive.Its efficacy has been found in several tests especially for the treatment of intraoperative pain. It remains more controversial in other indications. Evaluation of the value of auriculotherapy is often difficult because of the methodological limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed to improve the articular pains of patients treated by AA. This Phase III study aims at validate this approach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: Auriculotherapy for analgesic useAuriculotherapy for analgesic use |
| Controle arm | Placebo comparator | Device: Placebo auriculotherapyPlacebo auriculotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient over 18 years of age
- Patients with anti-aromatases in adjuvant treatment of breast cancer
- Menopausal women
- Treatment with aromatase inhibitors (anti-aromatase, AA) initiated for more than 3 months. In the case of a change in anti-aromatase, the last treatment must be started for more than 3 months.
- Musculoskeletal pain appearing or increased under AA:
Key exclusion criteria (6 listed)
- Patients who have already undergone treatment in auriculotherapy for the same indication
- Patient benefiting at the same time from a PNCAVT (acupuncture or homeopathy) for musculoskeletal pain
- Wearing hearing aids hindering the placement of semi-permanent needles (ASP)
- Wearing of a valve prosthesis
- Patient under guardianship or unable to give informed consent
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 |
|---|---|---|
| Auriculotherapy for analgesic useThe ASP will be applied to specific pain points | Device | Experimental arm |
| Placebo auriculotherapyThe ASP will be applied to placebo points (not specific to pain) | Device | Controle arm |
Primary outcome
Decrease in the overall pain score
Time frame: 3 months after auriculotherapy initiation
The proportion of patients with a 2-point or greater decrease in the overall pain
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 12 Sep 2025.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auriculotherapy for analgesic use in people with Musculoskeletal Pain and Breast Cancer, run by Centre Francois Baclesse at 7 sites 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 13 inclusion and 6 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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?
Decrease in the overall pain score (time frame: 3 months after auriculotherapy initiation). 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 12 Sep 2025.