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It involves conducting a clinical study on a population of healthy volunteers (age between 18 and 30 years) without direct benefit for the subject to explore a transfer of barium in the blood and urine following applications of thermal mud. The main objective is to highlight an increase in serum barium level of at least twice.
The presence of barium in thermal clays was noted by the ARS (french administration) who interviewed the Directorate General of Health (DGS); the latter seized the National Academy of Medicine (June 2016) which reported in February 2017.
In this report it was stated that there was no argument in favor of toxic phenomena related to the presence of barium but that it was appropriate, in particular, to evaluate a possible passage of barium in the skin in subjects who are treated with thermal mud
It will therefore be a prospective before-after interventional study, implementing 15 daily applications of 6 mud poultices made with a clay used as thermal clay and containing appreciable barium levels.
A surveillance will be put in place with the event of suspected event, the volunteer can then be seen by a doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mud therapy | Other | Application of sludge poultice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the plasma level of barium | Plasma level of barium | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the urinary rate of barium | Urinary rate of barium | 3 weeks |
| Plasma level of barium exceeds the level deemed tolerable by INRS (French Institute for Research and Security) | plasma levels of barium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jerome Dimet, PhD | Contact | 5.58.05.29.30 | 33 | jerome.dimet@ght40.fr |
| Anne-Hélène Boivin | Contact | 5.58.05.29.09 | 33 | anne-helene.boivin@ght40.fr |
| Name | Affiliation | Role |
|---|---|---|
| Frédéric Bauduer, Pr | Institut du thermalisme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut du Thermalisme | Recruiting | Dax | 40100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Roques CF, Trèves R, Queneau P, Bontoux D. Avis de l'académie nationale de médecine relatif à l'évaluation des risques sanitaires liés à la présence de baryum dans des argiles constitutives des boues thermales et à l'absence de contrôle sanitaire des boues thermales. Bull Acad Ntle Méd., , 201: 13-38, 2017. | ||
| Background | Ainouche R, Tabone W, Bouvier CE, Renaud V. Usage thérapeutique (des boues thermales), panorama du thermalisme français en 2013. Bulletin de l'AFTH (Association Française des Techniques Hydrothermales), 2014, n° 25, Symposium Utilisation des boues en établissement thermal, Enghien les Bains, Novembre 2013, pp. 7-11 | ||
| Background | Gomes C, Carretero MI, Pozo M, Maraver F, Cantista P et al. Peloids and pelotherapy : historical evolution, classification and glossary. Applied clay science 75-76:28-38, 2013. | ||
| 24008567 |
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| ID | Term |
|---|---|
| D009094 | Mud Therapy |
| ID | Term |
|---|---|
| D001452 | Balneology |
| D013812 | Therapeutics |
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| 3 weeks |
| Number of patients who doubles the urinary and plasma level of barium | plasma and urinary levels of barium | 3 weeks |
| Liu H, Zeng C, Gao SG, Yang T, Luo W, Li YS, Xiong YL, Sun JP, Lei GH. The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2013 Oct;41(5):1418-25. doi: 10.1177/0300060513488509. Epub 2013 Sep 5. |
| Background | Roques CF. Mud Therapy. Data of clinical evidence. Balnea 10:57-62, 2015. |
| 26203645 | Background | Xiang J, Wu D, Li J. Clinical Efficacy of Mudpack Therapy in Treating Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Studies. Am J Phys Med Rehabil. 2016 Feb;95(2):121-31. doi: 10.1097/PHM.0000000000000354. |
| 28644605 | Background | Roques CF, Queneau P. [SPA therapy for pain of patients with chronic low back pain, knee osteo-arthritis and fibromyalgia]. Bull Acad Natl Med. 2016 Mar;200(3):575-86; discussion 586-7. French. |
| Background | World Health Organization (WHO) - 2001 - IPCS (International Programme on Chemical Safety) - Concise international chemical assessment document 33 - barium and barium compounds. 57 pp |
| Background | Conseil canadien des Ministres de l'environnement - Recommandations canadiennes pour la qualité des sols - environnement et santé humaine. Le baryum. Feuillet d'information 2013, 1 doc 11 pp |
| 24844320 | Background | Kravchenko J, Darrah TH, Miller RK, Lyerly HK, Vengosh A. A review of the health impacts of barium from natural and anthropogenic exposure. Environ Geochem Health. 2014 Aug;36(4):797-814. doi: 10.1007/s10653-014-9622-7. Epub 2014 May 21. |
| Background | INRS - base de données de fiches toxicologiques. Baryum et composés. Fiche toxicologique complète n°125. 1 doc 12 pp, 2012 |
| 27122328 | Background | Ding C, Pan Y, Zhang A, Zhu C, Liu D, Xu G, Zheng Y, Yan H. [Distribution of rubidium, cesium, beryllium, strontium, and barium in blood and urine in general Chinese population]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2015 Dec;33(12):894-9. doi: 10.3760/cma.j.issn.1001-9391.2015.12.004. Chinese. |