Knee OsteoarthritisNCT03952897
Quality of Life Related to Health in Spa Users
An observational study of Knee Osteoarthritis and Hip Osteoarthritis, run by University of Castilla-La Mancha at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- balneotherapy
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Users of Fitero spa
Who may be able to join
- diagnosed arthrosis of knee or hip and/or rheumatoid arthrosis
- balneotherapy treatment of at least 10 days.
- physically and mentally able to complete questionnaires
Who cannot join
- have followed a balneotherapy treatment in the six previous month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study for the Assessment of Quality of Life Related to Health in Users of the Spa of Fitero (Navarra).
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).
Read more
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.
- Being tested
- balneotherapy
- Keywords
- knee osteoarthritis, rheumatoid arthritis, balneology, hip balneology
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balneotherapyOther
10 days of balneotherapy with immersion techniques using Fitero spa water.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Subjects treated with balneotherapy for 10 days, previously diagnosed with knee and/or hip osteoarthritis, and subjects previously diagnosed with rheumatoid arthritis. Receives: Other: balneotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: From 1st March 2019 to 1st December 2019
WOMAC
Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC)
Measured: From 1st March 2019 to 1st December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 May 2018
- Primary completion1 Mar 2019
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inés Martínez-Galán, MD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952897
- Sponsor's protocol ID
- EO-BALNEO-19
- Status last verified
- May 2019
- First submitted
- 7 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for the Assessment of Quality of Life Related to Health in Users of the Spa of Fitero (Navarra).
- ClinicalTrials.gov ID
- NCT03952897
- Acronym / sponsor ID
- EO-BALNEO-19
- Keywords
- knee osteoarthritis, rheumatoid arthritis, balneology, hip balneology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: balneotherapySubjects treated with balneotherapy for 10 days, previously diagnosed with knee and/or hip osteoarthritis, and subjects previously diagnosed with rheumatoid arthritis. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Users of Fitero spa
Key inclusion criteria (3 listed)
- diagnosed arthrosis of knee or hip and/or rheumatoid arthrosis
- balneotherapy treatment of at least 10 days.
- physically and mentally able to complete questionnaires
Key exclusion criteria (1 listed)
- have followed a balneotherapy treatment in the six previous month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balneotherapy10 days of balneotherapy with immersion techniques using Fitero spa water. | Other | Group 1 |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inés Martínez-Galán, MD principal investigator
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Hip Osteoarthritis, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAQ (Health Assessment Questionnaire)-Disability of rheumatic patients (time frame: From 1st March 2019 to 1st December 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.