Clinical trial NCT00773682: Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand
Official title: Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hands: a One Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: osteoarthritis
hands
mud-packs therapy
balneotherapy
Osteoarthritis of the hands
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Algofunctional state and quality of life
timeFrame: two weeks, three , six, nine and twelve months
Secondary outcomes:
measure: Consumption of symptomatic drugs and tolerability
timeFrame: two weeks, three, six, nine and twelve months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Study officials:
affiliation: Rheumatology Unit- Azienda Ospedaliera Universitaria Senese-siena
name: Antonella Fioravanti, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.