Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand (mdph)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00773682|
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : November 17, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Other: local mud-pack therapy and balneotherapy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hands: a One Year Follow-up|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||January 2010|
- Other: local mud-pack therapy and balneotherapy
Patients will be treated with local mud-pack application on the hands for 20 minutes and thermal-mineral bath once a day for 15 days.
- Algofunctional state and quality of life [ Time Frame: two weeks, three , six, nine and twelve months ]
- Consumption of symptomatic drugs and tolerability [ Time Frame: two weeks, three, six, nine and twelve months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773682
|Rheumatology Unit Azienda Ospedaliera Universitaria Senese|
|Siena, Italy, 53100|
|Principal Investigator:||Antonella Fioravanti, md||Rheumatology Unit- Azienda Ospedaliera Universitaria Senese-siena|