Osteoarthritis
Conditions
Keywords
osteoarthritis, hands, mud-packs therapy, balneotherapy, Osteoarthritis of the hands
Brief summary
Objective 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.
Detailed description
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.
Interventions
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.
Sponsors
University of Siena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients suffering from osteoarthritis of the hands according to the ACR criteria
Exclusion criteria
* Patients suffering from any other rheumatological disease other than osteoarthritis * Patients that have been treated with mud-pack therapy and balneotherapy in the last 9 months * Contraindications to mud-packs and balneotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Algofunctional state and quality of life | two weeks, three , six, nine and twelve months |
Secondary
| Measure | Time frame |
|---|---|
| Consumption of symptomatic drugs and tolerability | two weeks, three, six, nine and twelve months |
Countries
Italy
Outcome results
None listed