Forestier, Romain
Suehs, Carey
Françon, Alain
Marty, Marc
Genevay, Stéphane
Sellam, Jérémie
Chauveton, Claire
Erol Forestier, Fatma Begüm
Molinari, Nicolas
Funding for this research was provided by:
Association Française pour la Recherche Thermale (2017-01 LOMBATHERM')
Article History
Received: 22 December 2019
Accepted: 20 March 2020
First Online: 11 May 2020
Ethics approval and consent to participate
: This clinical trial will be conducted in accordance with national regulations in force, the declaration of Helsinki and Good Clinical Practice. Informed consent (including a signed consent form) will be sought from all participants prior to enrolment. The study protocol was approved by a randomly assigned, independent ethics committee in accordance with French law: Comité de Protection des Personnes Est IV; reference number: 19/08 – SI 18.11.15.62055. This ethics committee approval applies to all French centres. Any future substantial protocol modifications are also subject to approval from the same committee, as per regulations in force. In the case of substantial modification, the associated study declarations (NCT03910023 and ExternalRef removed) will be updated and the participating investigators informed of changes immediately. For centres outside of France, appropriate, ethics committee approval will be sought by local teams and publicly posted at ExternalRef removed prior to the start of recruitment in the corresponding centres.
: Not applicable.
: RF reports prior paid work for conception and writing for previous studies (knee osteoarthritis, rheumatology, phlebology) for the following entities: General Council of Savoy, Région Rhône-Alpes, Valvital Company. CMS, AF, MM, SG, JS, CC, FBER and NM have no conflicts of interest to report.