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Quality-of-life and Pain After Spa Treatment in Elderly With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03388801
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jolanta Zwolińska, University of Rzeszow

Study Description
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Brief Summary:

The aim of the study was to evaluate the short- and long-term effects of spa therapy on quality of life and pain in patients aged 65 years and older with osteoarthritis.

70 patients with osteoarthritis referred to spa treatment in south-eastern Poland were enrolled in the study. Spa treatment lasted 3 weeks.

All the patients benefited from spa therapy.

VAS pain scale, the Laitinen scale and WHOQOL-BREF questionnaire were used to assess the condition of the patients. The examinations were performed three times: at the beginning of the spa treatment, after three months and one year after the first examinations.


Condition or disease Intervention/treatment Phase
Osteoarthritis Quality of Life Elderly Balneology Other: Spa therapy Not Applicable

Detailed Description:

In an interventional study design, there have been examined patients aged over 65 years with the diagnosis of osteoarthritis who were prescribed a first spa therapy course in spa resorts in south-eastern Poland, between April 2016 and July 2016.

Patients were assessed by an experienced physicians on the first day of the spa therapy (study 1), after three months (study 2) and one year (study 3) after the completion of the spa therapy.

All patients who had been enrolled to the study, were asked to fill out the appropriate questionnaires (on the first day of the spa therapy). The investigators ensured that questionnaires were properly completed, under the supervision of researcher previously trained for their application. Second (study 2) and third (study 3) stages of the study were performed after three months, and one year after the first study, respectively (participants were interviewed by telephone survey).

Interventions Spa treatment was applied during a session lasting 120 to 150 minutes a day. Spa treatment lasted 3 weeks, including treatments from Monday to Friday (15 days of treatment). As a part of comprehensive spa treatment, all the patients benefited from kinesiotherapy, physical agent modalities (electrotherapy, phototherapy), massage and balneotherapy (peloid therapy, hydrotherapy with mineral waters, crenotherapy).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short and Long-term Follow-up of Quality-of-life and Pain After Spa Treatment in Elderly With Osteoarthritis
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Spa therapy
Spa treatment was applied during a session lasting 120 to 150 minutes a day. Spa treatment lasted 3 weeks, including treatments from Monday to Friday (15 days of treatment). As a part of comprehensive spa treatment, all the patients benefited from kinesiotherapy, physical agent modalities (electrotherapy, phototherapy), massage and balneotherapy (peloid therapy, hydrotherapy with mineral waters, crenotherapy).
 Other: Spa therapy
Spa treatment was applied during a session lasting 120 to 150 minutes a day. Spa treatment lasted 3 weeks, including treatments from Monday to Friday (15 days of treatment). As a part of comprehensive spa treatment, all the patients benefited from kinesiotherapy, physical agent modalities (electrotherapy, phototherapy), massage and balneotherapy (peloid therapy, hydrotherapy with mineral waters, crenotherapy).
Other Name: balneotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Change in the quality of life [ Time Frame: at baseline, 3 and 12 months ]
    Comparison of the WHOQOL-BREF questionnaire mean between baseline, 3 and 12 months. Quantitative evaluation of the primary outcome.


Secondary Outcome Measures :
  1. Change in pain perception (VAS) [ Time Frame: at baseline, 3 and 12 months ]
    Evolution of VAS (Visual Analogic Scale) between baseline, 3 and 12 months.

  2. Change in: pain intensity, frequency of pain, frequency of using painkillers and mobility [ Time Frame: at baseline, 3 and 12 months ]
    Evolution of the Modified Laitinen Pain Questionnaire between baseline, 3 and 12 months.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age over 65
  • diagnosis of osteoarthritis,
  • completion of 3 weeks of spa treatment
  • patient's consent to participate in the study

Exclusion Criteria:

  • failure to complete 3-weeks spa treatment,
  • significant random events during follow-up
  • diagnosed other diseases during follow-up,
  • other forms of therapy implemented during follow-up,
  • refusal to participate in II or III stage of the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388801


Sponsors and Collaborators
University of Rzeszow
Investigators
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Principal Investigator: Jolanta Zwolińska, Dr Medical Faculty, University of Rzeszów
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jolanta Zwolińska, Principal Investigator, University of Rzeszow
ClinicalTrials.gov Identifier: NCT03388801    
Other Study ID Numbers: Spa-osteoarthritis
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases