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BalneotherapyBalneotherapy'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
+12 Eligibility Criteria
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: June 6, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

In various pathologies associated with low-grade inflammation-especially rheumatic diseases-balneotherapy and mud therapy have been reported to decrease serum concentrations of pro-inflammatory cytokines such as TNF-α and IL-1β. COMP (cartilage oligomeric matrix protein) contributes to the stabilization of the collagen network by binding to collagen IX. Serum COMP levels are elevated in OA patients. There is evidence that measuring COMP levels could serve as a prognostic marker for the development of OA in patients with chronic knee pain. In OA, elevated IL-1 levels increase matrix metalloproteinase (MMP) levels and reduce TIMP synthesis. IL-1 plays the major role in the production of destructive enzymes. It also increases the synthesis of PGE2, which promotes inflammation and bone resorption. While severe heat stress causes cellular damage and cell death, the mild heat stress seen in balneotherapy induces a heat shock response. Following stress stimuli such as heat and inflammation, intracellular synthesis of heat shock proteins (HSp) increases, and there is a significant transition to the extracellular space. After heat stress, HSp levels in the blood increase, triggering the HSp-cytokine-HPA-cortisol anti-inflammatory feedback mechanism. To investigate the effect of balneotherapy on these markers; Male and female patients aged between 50 and 80 years with knee osteoarthritis (KOA) at stages 2 to 4 according to the Kellgren-Lawrence classification (Kellgren and Lawrence, 1957), based on imaging performed within the past year, were included in the study. The study is a parallel-group randomized controlled trial conducted at the Thermal Center of Kırşehir Ahi Evran Training and Research Hospital. The RCT was approved by the Ethics Committee of Kırşehir Ahi Evran University; The study is planned to start in July 2025 and to be completed in November 2025. Participants will be randomly assigned to the intervention and control groups in a 1:1 allocation ratio. The intervention group is planned to receive therapy 5 days a week, at the same time each morning, for 15-20 minutes per session, totaling 15 sessions. The control group will receive a home exercise program and simple analgesic treatment such as paracetamol. Both control and intervention groups received a booklet with general information and advice about how to improve the symptoms and progression of knee osteoarthritis. Data will be expressed as mean ± SD. Statistical analyses will be performed using SPSS version 22. A p-value of <0.05 will be considered statistically significant. Wilcoxon test will be used for comparisons before and after treatment, and Mann-Whitney U test will be used for comparisons between groups.

Principal SponsorAhi Evran University Education and Research Hospital
Last updated: June 6, 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 enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Knee

Criteria

4 inclusion criteria required to participate
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

8 exclusion criteria prevent from participating
Uncompensated cardiac or pulmonary problems

Infections

Corticosteroids or anti-cytokine therapy

Patients with a BMI over 30 kg/m2

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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.

Group II

Group 2- Patients in the control group will be followed up with only a home exercise program

Study Objectives

Primary Objectives

Secondary Objectives

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.
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