The Effect of Balneotherapy on Knee Osteoarthritis

NCT07008937 | Not Yet Recruiting

• 1 other identifier: 2021-06/63
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Osteoarthritis of Knee

Outcome Measures

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.

  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)

• Visual Analogue Scale

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

• Western Ontario ve McMaster Universities Osteoartrit (WOMAC)

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

• Short -Form 36

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

Study Arms (2)

Balneotherapy group (group 1)

EXPERIMENTAL

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

Other: Balneotherapy

Control Group (group 2)

OTHER

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

Other: home exercise program

Interventions

Balneotherapy OTHER

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.

Balneotherapy group (group 1)

home exercise program OTHER

home exercise program

Control Group (group 2)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Balneology

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 6, 2025
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share