Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand (mdph)
To assess both the short-term and the long term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA) in a single blind, prospective controlled, randomized trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hands: a One Year Follow-up|
- Algofunctional state and quality of life [ Time Frame: two weeks, three , six, nine and twelve months ] [ Designated as safety issue: No ]
- Consumption of symptomatic drugs and tolerability [ Time Frame: two weeks, three, six, nine and twelve months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Other: local mud-pack therapy and balneotherapy
Osteoarthritis is the most common form of joint disease and a major contributor of disability in older people. Current treatment of OA include pharmacological and non-pharmacological modalities. Spa therapy has a long history in the treatment of OA, but few articles have evaluated the effectiveness of thermal treatment in patients with primary OA of the hands.
The aim of this study is to assess the duration of the clinical effectiveness of mud-packs application and mineral bath in patients with primary OA of the hands in a single blind, controlled, randomized trial.
Our study will follow the patients for a longer period of time (12 months) than was done in previous studies.
60 outpatients will be enrolled; 30 patients will be treated with a combination of daily local mud packs and mineral bath water from the spa centre of Fonteverde Natural Spa Resort (San Casciano Terme, Siena, Italy) for two weeks; 30 patients will continue regular, routine ambulatory care. Patients will be assessed at baseline time, after 2 weeks, after 3, 6, 9 and 12 months following the beginning of the study and will be evaluated by VAS for spontaneous pain, Dreiser Algofunctional index, HAQ, AIMS1 and symptomatic drugs consumption.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773682
|Rheumatology Unit Azienda Ospedaliera Universitaria Senese|
|Siena, Italy, 53100|
|Principal Investigator:||Antonella Fioravanti, md||Rheumatology Unit- Azienda Ospedaliera Universitaria Senese-siena|