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

Phase 4

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00773682
• Lead Sponsor: University of Siena

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.

Study Timeline

• Study Start: 2008-06
• Status Verified: 2008-09
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2009-09
• Study Completion: 2010-01
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Algofunctional state and quality of life	two weeks, three , six, nine and twelve months

Secondary Outcome Measures

Name	Time	Method
Consumption of symptomatic drugs and tolerability	two weeks, three, six, nine and twelve months

Trial Locations

Locations (1)

Rheumatology Unit Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy