Quality of Life Related to Health in Spa Users

• Conditions: Hip Osteoarthritis; Rheumatoid Arthritis; Knee Osteoarthritis
• Interventions: Other: balneotherapy

• Registration Number: NCT03952897
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-03-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Last Update Submitted: 2019-05-22
• Last Update Posted: 2019-05-24
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	balneotherapy	Subjects treated with balneotherapy for 10 days, previously diagnosed with knee and/or hip osteoarthritis, and subjects previously diagnosed with rheumatoid arthritis.

Primary Outcome Measures

Name	Time	Method
HAQ (Health Assessment Questionnaire)-Disability of rheumatic patients	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	From 1st March 2019 to 1st December 2019	Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC)

Trial Locations

Locations (1)

Universidad de Castilla-La Mancha; 🇪🇸 Toledo, Spain