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Osteoarthritis of KneeBalneotherapyNCT07008937

The Effect of Balneotherapy on Knee Osteoarthritis

A study testing Balneotherapy and home exercise program in people with Osteoarthritis of Knee, run by Ahi Evran University Education and Research Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Osteoarthritis (OA) is a chronic degenerative disease characterized by the breakdown and repair processes of the cartilage structure in synovial joints. Balneotherapy is one of the most commonly applied treatment methods in patients with OA. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Osteoarthritis of Knee
What is being tested?
Balneotherapy and home exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Jul 2025to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: The Effect of Balneotherapy on the Inflammatory Process and Quality of Life in Patients With Knee Osteoarthritis

Osteoarthritis (OA) is a chronic degenerative disease characterized by the breakdown and repair processes of the cartilage structure in synovial joints. Balneotherapy is one of the most commonly applied treatment methods in patients with OA. It is used to reduce pain and stiffness, improve joint mobility and quality of life, and prevent disease progression. Hyperthermia caused by balneotherapy activates the sympathetic nervous system and the hypothalamic-pituitary-adrenal (HPA) axis. After heat stress, HSp levels in the blood increase, triggering the HSp-cytokine-HPA-cortisol anti-inflammatory feedback mechanism, resulting in an anti-inflammatory effect and neuroendocrine immune regulation.

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. 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. It is evaluated not only as a cartilage marker but also as an indicator of synovial inflammation.

Read more

The aim of this study is to evaluate the response to inflammation and stress in patients with knee OA by examining the levels of CRP, IL-1 beta, COMP, and HSp following balneotherapy treatment. Additionally, changes in patients' quality of life and functional status after balneotherapy will also be evaluated.Fifty patients with primary osteoarthritis who meet the inclusion criteria and are receiving inpatient or outpatient treatment in the Physical Medicine and Rehabilitation clinic will be included in the study. It is planned to include 30 patients in the treatment group and 20 patients in the control group. Pain will be assessed using VAS, physical function and stiffness using WOMAC, and quality of life using the SF-36 scale. To determine the serum levels of COMP, IL-1 beta, CRP, and HSp70, blood samples will be collected under standard conditions from patients in a fasting state between 8:00-9:00 AM. Biochemical markers will be evaluated using ELISA kits.

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.

Read the detailed description

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.

Being tested
Balneotherapy, home exercise program
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BalneotherapyOther

    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.

  • home exercise programOther

    home exercise program

Study groups in NCT07008937
Study groupRoleWhat they receive
Balneotherapy group (group 1)ExperimentalGroup 1 -Patients in the research group will receive geothermal treatment (spa therapy) for 20 minutes daily for 15 days.
Receives: Other: Balneotherapy
Control Group (group 2)OtherGroup 2- Patients in the control group will be followed up with only a home exercise program
Receives: Other: home exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the serum levels of COMP, IL-1 beta, CRP, and HSp70

    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.

    Measured: Levels of COMP, IL-1 beta, CRP, and HSp70 will be measured one day before the start of the balneotherapy (baseline) and one day after completing the 15-session therapy (15 days)

Secondary outcomes (3)
  1. Visual Analogue Scale

    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').

    Measured: Assessments will be made at baseline and at the end of treatment (15 season ) completion (15 days) for both groups.

  2. Western Ontario ve McMaster Universities Osteoartrit (WOMAC)

    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.

    Measured: Assessments will be made at baseline and at the end of treatment (15 season ) completion (15 days) for both groups.

  3. Short -Form 36

    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.

    Measured: Assessments will be made at baseline and at the end of treatment (15 season ) completion (15 days) for both groups.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionNov 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07008937
Sponsor's protocol ID
2021-06/63
Acronym
Balneotherapy
Status last verified
Jun 2025
First submitted
23 May 2025
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Balneotherapy and home exercise program in people with Osteoarthritis of Knee, run by Ahi Evran University Education and Research Hospital.

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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

the serum levels of COMP, IL-1 beta, CRP, and HSp70 (time frame: Levels of COMP, IL-1 beta, CRP, and HSp70 will be measured one day before the start of the balneotherapy (baseline) and one day after completing the 15-session therapy (15 days)). 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 6 Jun 2025.

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