Resumen de Balneotherapy in knee osteoarthritis: a cost/effectiveness analysis alongside an Italian randomized controlled clinical trial
Andrea M Fioravanti, O. Ciani, S. Cheleschi, S. Tenti
Objective To perform a cost-effectiveness analysis of mud-bath therapy (MBT) in addition to usual treatment compared to usual treatment alone in patients with bilateral knee osteoarthritis (OA).
Design and Method This is a prospective randomized, controlled single-blind (assessor) trial. The study protocol was approved by the Ethics Committee of Siena University Hospital and registered on http://www.clinicaltrials.gov (NCT01538043).
Patients aged between 40 and 80 years of both sexes with primary symptomatic bilateral knee OA (ACR criteria) and with a Kellgren - Lawrence radiological score between I–III were recruited in the area near the Health Resort of Chianciano Terme (Siena, Italy), allowing them to continue to live at home and carry out their daily routines during the study period.
Patients were randomly assigned to receive either a 2 weeks cycle of MBT in addition to their usual treatment or to continue routine care alone. The European Quality-of-Life Questionnaire-5 Dimensions (EQ-5D) was administered at baseline, 2 weeks, 3, 6, 9, and 12 months. Direct healthcare resource consumption (drug’s consumption, laboratory and imaging tests, general practitioners and specialists visits, physical therapies and devices) for the treatment of knee OA up until 12 months were derived from a daily diary given to patients and returned at prescheduled follow-up visits.
