Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT05058092
Eligibility Criteria:
Inclusion Criteria:
* clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (Wolfe et al., 2016),
* FIQ score ≥ 39 (moderate and higher forms) on the day of inclusion (D0),
* with a smartphone that runs on Android 8 and iOS 12 or later,
* agreeing the installation of the Fibrepik app on the smartphone,
* agreeing the collection of the number of steps measured by the smartphone,
* agreeing the installation of the Google Fit app for patients whose smartphone runs on Android (necessary for the collection of the number of steps),
* wrist size compatible with the size M or L of the wristband template,
* affiliated to the social security system or beneficiary of such a system,
* who have signed a consent to participate.
Exclusion Criteria:
* with a characterized depressive episode according to the DSM 5,
* substantial change in treatment in the three months prior to inclusion and in the months to come: change in analgesic level, introduction of a new treatment.
* with a chronic inflammatory pathology (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, lupus,...),
* person in civil proceedings,
* having a dermatological pathology on the wrists, such as oozing dermatosis, hyper sweat or an unhealed lesion,
* with a surgical implant, tattoo or piercing on one of the wrists,
* allergic to metals and/or silicone,
* referred to articles L1121-5 to L1121-8 of the French Public Health Code (CSP): Pregnant, parturient or nursing woman; Person deprived of liberty by judicial or administrative decision; Person subject to a legal protection measure or unable to express his/her consent; Person under psychiatric care
* in a period of exclusion from other interventional research.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05058092
Study Brief:
Protocol Section:
NCT05058092