Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand (mdph)

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ClinicalTrials.gov Identifier: NCT00773682

Recruitment Status : Completed

First Posted : October 16, 2008

Last Update Posted : November 17, 2011

Sponsor:

Information provided by (Responsible Party):

fioravanti antonella, University of Siena

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Other: local mud-pack therapy and balneotherapy	Phase 4

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Osteoarthritis

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Arms and Interventions

Intervention Details:

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.

Outcome Measures

Primary Outcome Measures :

Algofunctional state and quality of life [ Time Frame: two weeks, three , six, nine and twelve months ]

Secondary Outcome Measures :

Consumption of symptomatic drugs and tolerability [ Time Frame: two weeks, three, six, nine and twelve months ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Italy
Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100

Sponsors and Collaborators

University of Siena

Investigators


Principal Investigator:	Antonella Fioravanti, md	Rheumatology Unit- Azienda Ospedaliera Universitaria Senese-siena

More Information

Publications:

Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F. Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int. 2007 Oct;27(12):1157-61. Epub 2007 May 23.

Cantarini L, Leo G, Giannitti C, Cevenini G, Barberini P, Fioravanti A. Therapeutic effect of spa therapy and short wave therapy in knee osteoarthritis: a randomized, single blind, controlled trial. Rheumatol Int. 2007 Apr;27(6):523-9. Epub 2006 Nov 15.

Fioravanti A, Valenti M, Altobelli E, Di Orio F, Nappi G, Crisanti A, Cantarini L, Marcolongo R. Clinical efficacy and cost-effectiveness evidence of spa therapy in osteoarthritis. The results of "Naiade" Italian Project. Panminerva Med. 2003 Sep;45(3):211-7.


Responsible Party:	fioravanti antonella, medical doctor, University of Siena
ClinicalTrials.gov Identifier:	NCT00773682 History of Changes
Other Study ID Numbers:	339/07
First Posted:	October 16, 2008 Key Record Dates
Last Update Posted:	November 17, 2011
Last Verified:	September 2008

Keywords provided by fioravanti antonella, University of Siena:


osteoarthritis hands mud-packs therapy balneotherapy Osteoarthritis of the hands

Additional relevant MeSH terms:


Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

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