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CompletedNCT03096041TRIPLE-AUpdated Sep 12, 2025

Phase 3 Study Randomized Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors

An interventional study of Auriculotherapy for analgesic use and Placebo auriculotherapy in Musculoskeletal Pain and Breast Cancer, sponsored by Centre Francois Baclesse. Completed at 7 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Centre Francois Baclesse · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
197
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

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Conditions studied

  • Musculoskeletal Pain
  • Breast Cancer

Keywords

  • auriculotherapy
  • aromatase inhibitors
  • adjuvant treatment
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In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.

This study's enrollment of 197 is above the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

Centre Francois Baclesse is the lead sponsor of 109 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
197 participants (actual)

Study arms

  • Experimental
    Experimental arm

    Auriculotherapy for analgesic use

    Device: Auriculotherapy for analgesic use

  • Placebo comparator
    Controle arm

    Placebo auriculotherapy

    Device: Placebo auriculotherapy

Interventions

  • DeviceAuriculotherapy for analgesic use

    The ASP will be applied to specific pain points

  • DevicePlacebo auriculotherapy

    The ASP will be applied to placebo points (not specific to pain)

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What researchers measure

Primary outcomes

  1. Decrease in the overall pain score

    The proportion of patients with a 2-point or greater decrease in the overall pain

    Time frame: 3 months after auriculotherapy initiation

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Study locations

7 sites
  • Centre François Baclesse
    Caen, 14000, France
  • Hôpital Privé Paul d'Egine
    Champigny-sur-Marne, France
  • Hôpital Cognac-Jay - Forcilles
    Férolles-Attilly, France
  • CHU Grenoble
    Grenoble, France
  • Centre Oscar Lambret
    Lille, France
  • Groupe Hospitalier Paris St Joseph
    Paris, France
  • IGR
    Villejuif, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03096041
Lead sponsor
Centre Francois Baclesse
Responsible party
Sponsor
First posted
Mar 30, 2017
Start date
Jul 5, 2017
Primary completion
Jul 7, 2025
Completion
Jul 7, 2025
Last update
Sep 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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