Quality of Life Related to Health in Spa Users

Rheumatoid Arthritis Clinical Trial

Official title:

Observational Study for the Assessment of Quality of Life Related to Health in Users of the Spa of Fitero (Navarra).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03952897
• Other study ID #: EO-BALNEO-19
• Status: Active, not recruiting
• Start date: May 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2019
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Rheumatoid Arthritis

Intervention

Other:
• balneotherapy
10 days of balneotherapy with immersion techniques using Fitero spa water.

Locations

Country	Name	City	State
Spain	Universidad de Castilla-La Mancha	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAQ (Health Assessment Questionnaire)-Disability of rheumatic patients	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".	From 1st March 2019 to 1st December 2019
Primary	WOMAC	Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC)	From 1st March 2019 to 1st December 2019