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Balneotherapy

Balneotherapy's Impact on Inflammation and Quality of Life in Knee Osteoarthritis

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What is being tested

Balneotherapy

+ home exercise program
Other
Who is being recruted

Arthritis
+3

+ Joint Diseases
+ Musculoskeletal Diseases
Over 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorAhi Evran University Education and Research Hospital
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2025Actual date on which the first participant was enrolled.

The study aims to explore the effects of balneotherapy, which involves treatments using mineral-rich water, on knee osteoarthritis. Specifically, the research focuses on how this therapy might reduce inflammation and improve quality of life for adults aged 50 to 80 who have moderate to severe knee osteoarthritis. This condition often leads to joint pain and stiffness, and the study seeks to understand if balneotherapy can lower harmful substances in the blood that contribute to inflammation and joint damage. By potentially reducing these markers, the treatment could offer a new way to manage symptoms and slow disease progression, providing a valuable option for those affected by this common and often painful condition. Participants in the study are randomly divided into two groups. One group receives balneotherapy sessions at a thermal center for 15 to 20 minutes each morning, five days a week, over three weeks. The other group follows a home exercise routine and uses pain relief medication like paracetamol. Both groups receive educational material on managing knee osteoarthritis. The study measures changes in specific blood markers before and after treatment to assess the effects of the therapies. Statistical tests will help determine if there are significant differences between the groups, offering insights into the potential benefits of balneotherapy for knee osteoarthritis.

Official TitleThe Effect of Balneotherapy on the Inflammatory Process and Quality of Life in Patients With Knee Osteoarthritis 
NCT07008937
Principal SponsorAhi Evran University Education and Research Hospital
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Arthritis
Joint Diseases
Musculoskeletal Diseases
Osteoarthritis
Rheumatic Diseases
Osteoarthritis, Knee
Criteria

Inclusion Criteria: * Being over 50 years old * Patients diagnosed with knee OA * At stages 2-to-4 according to the Kellgren- Lawrence classification * Patients who agree to receive balneotherapy treatment Exclusion Criteria: * Neoplasia * Infections * Uncompensated cardiac or pulmonary problems * Total knee arthroplasty * Inflammatory joint diseases (e.g., RA, AS) * Intra-articular injections in the past 6 months * Corticosteroids or anti-cytokine therapy * Patients with a BMI over 30 kg/m2

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Group 1 -Patients in the research group will receive geothermal treatment (spa therapy) for 20 minutes daily for 15 days.

For balneotherapy, patients will be treated in a thermal pool for 15-20 minutes daily, with full-body immersion, for a total of 15 days. For control, Volunteers in the control group will only receive a home exercise program. They will be called in for a check-up every five days to confirm that the home program is being followed correctly. In this way, the volunteers in the control group will not be left completely without treatment.
Group II
Group 2- Patients in the control group will be followed up with only a home exercise program

home exercise program
Study Objectives
Primary Objectives

Before starting the treatment and one day after completing the 15-session balneotherapy, levels of COMP, IL-1 beta, CRP, and HSp70 will be measured in the intervention group.
Secondary Objectives

The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations.

The SF-36 is used to objective measure of the quality of life.It comprises 36 questions that cover eight domains of health. Higher scores indicate better health status.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
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