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Completed

NCT Number: NCT00773682

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rheumatology Unit Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

local mud-pack therapy and balneotherapy

Other

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.

Primary outcomes

  1. Algofunctional state and quality of life

    Time frame: two weeks, three , six, nine and twelve months

Secondary outcomes

  1. Consumption of symptomatic drugs and tolerability

    Time frame: two weeks, three, six, nine and twelve months

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

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

Acronym: mdph

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 16, 2008
Registry last updated
Nov 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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