NCT01538043

Brief Summary

The aim of this study is to evaluate both cost/effectiveness- cost/utility and the possible mechanisms of action of spa therapy in patients with primary knee osteoarthritis (OA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

2.4 years

First QC Date

February 13, 2012

Last Update Submit

July 1, 2014

Conditions

Osteoarthritis, Knee

Keywords

Cost-effectiveness analysisCost-utility analysisOsteoarthritisSpa therapyRandomized clinical trialMechanisms of action

Outcome Measures

Primary Outcomes (1)

  • cost/effectiveness- cost/utility for spa therapy compared to conventional treatments in knee osteoarthritis

    to evaluate for the first time cost/effectiveness- cost/utility for spa therapy compared to conventional treatments by a randomized single blind controlled trial in knee osteoarthritis

    baseline and twelve months

Secondary Outcomes (1)

  • changes of certain markers or mediators of cartilage damage

    baseline and two weeks

Study Arms (2)

local mud packs and thermal-mineral bath

ACTIVE COMPARATOR

50 patients with primary knee OA will be treated with daily local mud packs and thermal-mineral bath at Chianciano Terme Spa Center (Siena, Italy) for a total of 12 applications carried out over a period of two weeks

Other: local mud-pack therapy and balneotherapy

regular routine ambulatory care

NO INTERVENTION

50 patients, the control group, will continue regular routine ambulatory care

Interventions

local mud-pack therapy and balneotherapyOTHER

local mud-pack therapy and thermal-mineral bath at Chianciano Terme Spa Center (Siena, Italy) for a total of 12 applications carried out over a period of two weeks

Also known as: mud pack therapy
local mud packs and thermal-mineral bath

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients suffering from OA of the knee according to American College of Rheumatology (ACR) criteria and to standard radiography of the knee

You may not qualify if:

  • patients enrolled in other research protocols
  • patients that have been treated with mud-pack therapy and balneotherapy in the last 9 months
  • patients affected by neoplastic diseases or in the last five years, with cardiovascular disease of recent onset, suffering from inflammatory diseases in the acute phase, serious impairment of hematopoietic, renal and hepatic systems, other inflammatory rheumatic or autoimmune disorders, or unable to complete the questionnaires and the daily diary for the collection of socio-economic data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Unit Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Related Publications (10)

  • 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.

    PMID: 14618120BACKGROUND

  • 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.

    PMID: 17106661BACKGROUND

  • Fioravanti A, Iacoponi F, Bellisai B, Cantarini L, Galeazzi M. Short- and long-term effects of spa therapy in knee osteoarthritis. Am J Phys Med Rehabil. 2010 Feb;89(2):125-32. doi: 10.1097/PHM.0b013e3181c1eb81.

    PMID: 19884812BACKGROUND

  • Fioravanti A, Cantarini L, Bacarelli MR, de Lalla A, Ceccatelli L, Blardi P. Effects of spa therapy on serum leptin and adiponectin levels in patients with knee osteoarthritis. Rheumatol Int. 2011 Jul;31(7):879-82. doi: 10.1007/s00296-010-1401-x. Epub 2010 Mar 18.

    PMID: 20237929BACKGROUND

  • Fioravanti A, Cantarini L, Guidelli GM, Galeazzi M. Mechanisms of action of spa therapies in rheumatic diseases: what scientific evidence is there? Rheumatol Int. 2011 Jan;31(1):1-8. doi: 10.1007/s00296-010-1628-6. Epub 2010 Dec 1.

    PMID: 21120502BACKGROUND

  • Fioravanti A, Giannitti C, Bellisai B, Iacoponi F, Galeazzi M. Efficacy of balneotherapy on pain, function and quality of life in patients with osteoarthritis of the knee. Int J Biometeorol. 2012 Jul;56(4):583-90. doi: 10.1007/s00484-011-0447-0. Epub 2011 May 15.

    PMID: 21573819BACKGROUND

  • Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

    PMID: 19734131BACKGROUND

  • Ciani O, Pascarelli NA, Giannitti C, Galeazzi M, Meregaglia M, Fattore G, Fioravanti A. Mud-Bath Therapy in Addition to Usual Care in Bilateral Knee Osteoarthritis: An Economic Evaluation Alongside a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):966-972. doi: 10.1002/acr.23116. Epub 2017 Jun 7.

    PMID: 27723261DERIVED

  • Chung KC, Kotsis SV, Burns PB, Burke FD, Wilgis EFS, Fox DA, Kim HM. Seven-Year Outcomes of the Silicone Arthroplasty in Rheumatoid Arthritis Prospective Cohort Study. Arthritis Care Res (Hoboken). 2017 Jul;69(7):973-981. doi: 10.1002/acr.23105. Epub 2017 Jun 9.

    PMID: 27696739DERIVED

  • Fioravanti A, Giannitti C, Cheleschi S, Simpatico A, Pascarelli NA, Galeazzi M. Circulating levels of adiponectin, resistin, and visfatin after mud-bath therapy in patients with bilateral knee osteoarthritis. Int J Biometeorol. 2015 Nov;59(11):1691-700. doi: 10.1007/s00484-015-0977-y. Epub 2015 Mar 7.

    PMID: 25750093DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

BalneologyMud Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Antonella Fioravanti, MD

    Rheumatology Unit- Azienda Ospedaliera Universitaria Senese- Siena- Italy

    PRINCIPAL INVESTIGATOR

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

February 13, 2012

First Posted

February 23, 2012

Study Start

December 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

IT(1)