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Osteoarthritis, KneePhase 4NCT01538043

Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action

A Phase 4 study testing local mud-pack therapy and balneotherapy in people with Osteoarthritis, Knee, run by University of Siena at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
local mud-pack therapy and balneotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteItaly
Study dates
Dec 2010to May 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Rheumatology Unit Azienda Ospedaliera Universitaria Senese

    Siena, 53100

Other trials in Italy

About this study

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).

Read the detailed description

OA is the most common rheumatic disease and the most important from the social-economic point of view because of its frequency, causing functional impairment and disability in older people, important health resource utilization and costs (drugs, physical therapies, spa therapy, surgical prothesis, early retirement).

Thermal therapy is one of the most commonly used non-pharmacological approaches for OA, but it is still being discussed and its role in modern medicine is still not clear. The action mechanisms of mud packs and thermal baths are not completely known, and it is difficult to distinguish the effects of thermal applications from the benefits that could be derived from a stay in a spa environment. Furthermore, there are no data about cost analysis of spa therapy in OA.

The aim of this study is to analyze for the first time the cost/effectiveness- cost/utility for spa therapy in comparison to conventional treatments in knee OA (one-year-follow-up)and to assess changes of some biomarkers or mediators of cartilage damage in order to identify new possible mechanisms of action of spa therapy in rheumatic diseases.

Being tested
local mud-pack therapy and balneotherapy
Keywords
Cost-effectiveness analysis, Cost-utility analysis, Osteoarthritis, Spa therapy, Randomized clinical trial, Mechanisms of action
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • local mud-pack therapy and balneotherapyOther

    Also called mud pack therapy

    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

Study groups in NCT01538043
Study groupRoleWhat they receive
local mud packs and thermal-mineral bathActive comparator50 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
Receives: Other: local mud-pack therapy and balneotherapy
regular routine ambulatory careNo intervention50 patients, the control group, will continue regular routine ambulatory care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline and twelve months

Secondary outcomes (1)

  1. changes of certain markers or mediators of cartilage damage

    to assess changes of certain markers or mediators of cartilage damage in order to identify new possible mechanisms of action of spa therapy in rheumatic diseases.

    Measured: baseline and two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2012 (estimated)
  2. Study startDec 2010
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01538043
Sponsor's protocol ID
TAC2010
Status last verified
Jul 2014
First submitted
13 Feb 2012
Last updated
2 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14618120

  • 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.

    PubMed 17106661

  • 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.

    PubMed 19884812

  • 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.

    PubMed 20237929

  • 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.

    PubMed 21120502

  • 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.

    PubMed 21573819

  • 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.

    PubMed 19734131

  • 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.

    PubMed 27723261

  • 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.

    PubMed 27696739

  • 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.

    PubMed 25750093

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing local mud-pack therapy and balneotherapy in people with Osteoarthritis, Knee, run by University of Siena at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cost/effectiveness- cost/utility for spa therapy compared to conventional treatments in knee osteoarthritis (time frame: baseline and twelve months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01538043, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.

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