The Effect of Balneotherapy on Knee Osteoarthritis
ConditionOsteoarthritis of Knee
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorAhi Evran University Education and Research Hospital
About this trial
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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Neoplasia
Infections
Uncompensated cardiac or pulmonary problems
Total knee arthroplasty
Trial design
Design model
Parallel
Treatments tested in this trial
Balneotherapy
Other interventionFor 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 program
Other interventionhome exercise program
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Balneotherapy group (group 1)Experimental treatment 1 intervention
Group B: Control Group (group 2)Other 1 intervention
Trial outcomes
Primary outcomes
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.
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)Secondary outcomes
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').
Time frame
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.
Time frame
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.
Time frame
Assessments will be made at baseline and at the end of treatment (15 season ) completion (15 days) for both groups.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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