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
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|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|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|
Subjects treated with balneotherapy for 10 days, previously diagnosed with knee and/or hip osteoarthritis, and subjects previously diagnosed with rheumatoid arthritis.
10 days of balneotherapy with immersion techniques using Fitero spa water.
- 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".
- WOMAC [ Time Frame: From 1st March 2019 to 1st December 2019 ]Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC)
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
|Universidad de Castilla-La Mancha|
|Toledo, Spain, 45122|
|Principal Investigator:||Inés Martínez-Galán, MD||University of Castilla-La Mancha|