Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hands: a One Year Follow-up

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: local mud-pack therapy and balneotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algofunctional state and quality of life |  | two weeks, three , six, nine and twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of symptomatic drugs and tolerability |  | two weeks, three, six, nine and twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, hands, mud-packs therapy, balneotherapy, Osteoarthritis of the hands