Quality of Life Related to Health in Spa Users
|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)
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|