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Quality of Life Related to Health in Spa Users

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ClinicalTrials.gov Identifier: NCT03952897
Recruitment Status : Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Castilla-La Mancha

Brief Summary:

Hypothesis: The spa therapy treatment could improve health-related quality of life (HRQOL) in subjects with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis.

Main objective: Analyze if HRQOL in patients with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis is modified by spa therapy treatment in the spa of Fitero (Spain).

Design: Prospective observational study Participants: Fitero's spa users aged between 45-80 years old, diagnosed with knee and/or hip osteoarthritis, and also with rheumatoid arthritis. At least 40 patients of each type will be included in the study. Participants must be receiving a treatment of at least ten days.

Main Variable: The scores obtained in the Euroqol5Dimensions-5Levels questionnaire (EQ-5D-5L) (for all subjects), the Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) questionnaire, for subjects with knee and/or hip osteoarthritis, and the Health Assessment Questionnaire (HAQ), for subjects with rheumatoid arthritis.

Other variables: sociodemographic, anthropometric, clinics, and related with spa treatment.

Follow-up duration: 9 months.


Condition or disease Intervention/treatment
Knee Osteoarthritis Hip Osteoarthritis Rheumatoid Arthritis Other: balneotherapy

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study for the Assessment of Quality of Life Related to Health in Users of the Spa of Fitero (Navarra).
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : March 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
Subjects treated with balneotherapy for 10 days, previously diagnosed with knee and/or hip osteoarthritis, and subjects previously diagnosed with rheumatoid arthritis.
Other: balneotherapy
10 days of balneotherapy with immersion techniques using Fitero spa water.




Primary Outcome Measures :
  1. HAQ (Health Assessment Questionnaire)-Disability of rheumatic patients [ Time Frame: From 1st March 2019 to 1st December 2019 ]
    Health Assessment Questionnaire (HAQ) assays the disability of rheumatic patients to carry out daily life activities. The questionary consists on 20 daily life questions, grouped in 8 areas, each one containing two or three questions related to daily life activities. Each question is scored from 0-3. 0 means "done without difficulties" (no disability), 3 score is "impossible to do" (completely disabled). The average of all responses is done. Average scores from 0-1 represent "mild to moderate difficulty", 1-2 means "moderate to severe disability", 3-2 indicates "severe to very severe disability".

  2. WOMAC [ Time Frame: From 1st March 2019 to 1st December 2019 ]
    Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Users of Fitero spa
Criteria

Inclusion Criteria:

  • diagnosed arthrosis of knee or hip and/or rheumatoid arthrosis
  • balneotherapy treatment of at least 10 days.
  • physically and mentally able to complete questionnaires

Exclusion Criteria:

  • have followed a balneotherapy treatment in the six previous month

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): NCT03952897


Locations
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Spain
Universidad de Castilla-La Mancha
Toledo, Spain, 45122
Sponsors and Collaborators
University of Castilla-La Mancha
Investigators
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Principal Investigator: Inés Martínez-Galán, MD University of Castilla-La Mancha

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Responsible Party: University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT03952897     History of Changes
Other Study ID Numbers: EO-BALNEO-19
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Castilla-La Mancha:
knee osteoarthritis
rheumatoid arthritis
balneology
hip balneology

Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Osteoarthritis, Knee
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases