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

NCT ID: NCT00773682

Last Updated: 2011-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-01-31

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.

Conditions

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Osteoarthritis

Keywords

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osteoarthritis hands mud-packs therapy balneotherapy Osteoarthritis of the hands

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Siena

OTHER

Sponsor Role lead

Responsible Party

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fioravanti antonella

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonella Fioravanti, md

Role: PRINCIPAL_INVESTIGATOR

Rheumatology Unit- Azienda Ospedaliera Universitaria Senese-siena

Locations

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Rheumatology Unit Azienda Ospedaliera Universitaria Senese

Siena, Siena, Italy

Site Status

Countries

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Italy

References

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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. doi: 10.1007/s00296-007-0358-x. Epub 2007 May 23.

Reference Type BACKGROUND
PMID: 17520260 (View on PubMed)

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. doi: 10.1007/s00296-006-0266-5. Epub 2006 Nov 15.

Reference Type BACKGROUND
PMID: 17106661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14618120 (View on PubMed)

Other Identifiers

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339/07

Identifier Type: -

Identifier Source: org_study_id