Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand
mdph
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 15, 2008
CompletedFirst Posted
Study publicly available on registry
October 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedNovember 17, 2011
September 1, 2008
1.3 years
October 15, 2008
November 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Algofunctional state and quality of life
two weeks, three , six, nine and twelve months
Secondary Outcomes (1)
Consumption of symptomatic drugs and tolerability
two weeks, three, six, nine and twelve months
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients suffering from osteoarthritis of the hands according to the ACR criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Siena, Siena, 53100, Italy
Related Publications (3)
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.
PMID: 17520260BACKGROUNDCantarini 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.
PMID: 17106661BACKGROUNDFioravanti 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.
PMID: 14618120BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonella Fioravanti, md
Rheumatology Unit- Azienda Ospedaliera Universitaria Senese-siena
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
October 15, 2008
First Posted
October 16, 2008
Study Start
June 1, 2008
Primary Completion
September 1, 2009
Study Completion
January 1, 2010
Last Updated
November 17, 2011
Record last verified: 2008-09