Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis

Study Overview
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Brief Summary
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This study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the osteoarthritis patients, as well as water the application of exercise in water effects the results we receive.

Detailed Description
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Sulfur baths and mud packs are known to have a positive effect in patients with osteoarthritis (OA). OA is a chronic degenerative disease accompanied by a constant pain that often leads to changes in the mood of patients. Over the last few decades, numerous articles reported various beneficial effects of sulfur water and peloid therapeutic applications. Serotonin is one of the important neurotransmitters that have numerous functions such as regulation of body temperature, sleep, appetite, while its main function is reflected in controling of depression. The aim of this study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the OA patients, as well as whether the application of exercise in water effects the results we receive. Randomized controlled study included patients with hip and/or knee OA both sexes, randomized into two groups. The first group patients underwent sulfur balneotherapy and mud pack therapy. Patients in the second group had sulfur balneotherapy, mud pack therapy and exercise in hygienic water. The duration of spa therapy program was 12 days. Serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy. This study is expected to be another contribution to existing evidence and shed light on the mechanisms of beneficial effects of balneotherapy and mud therapy and whether addition underwater exercise would have extra therapeutic effects.

Official Title
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Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis

Conditions
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Osteoarthritis of Multiple Joints

Intervention / Treatment
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* Other: Mud therapy application
* Other: Sulfur water application
* Other: Hygienic water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages of 50 - 65 , both sexes Patients diagnosed with hip and / or knee OA without having used balneotherapy in the previous year Patients who have not changed their medication in the last 2 months Patients who have not received injections into the hip and / or knee joint in the last 6 months (PRP, Diprofos…) Exclusion Criteria: Secondary hip and / or knee OA Patients with MOA inhibitors, selective serotonin inhibitors, morphine, lithium and methyldopa in therapy Visible disruption of hip and / or knee joint structures Treatment of malignancy Diseases of the heart, lungs, decompensated conditions of other organs, infections, active bleeding Severe hip and / or knee joint injuries, fractures, and previous surgical procedures Physical therapy, balneotherapy back one year

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group of sulfur balneotherapy and mud pack therapy<br>Experimental group patients underwent sulfur balneotherapy and mud pack therapy. The duration of spa therapy program was 12 days.From the blood of patients, serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy. | Other: Mud therapy application<br>* Aplication the mud pack therapy from 20 minutes<br>* Other names: mud pack;Other: Sulfur water application<br>* Aplication the sulfur water in bath from 20 minutes<br>* Other names: Sulfur bath;|
| Active Comparator: Group of sulfur balneotherapy, mud pack therapy and exercise<br>Control group of patients had mud pack therapy, sulfur balneotherapy and exercise in hygienic water. This group is a hydro group. From the blood of patients we analyzed parameters od complete blood count, serotonin values, lipid status and inflammatory markers before and after the therapy. | Other: Mud therapy application<br>* Aplication the mud pack therapy from 20 minutes<br>* Other names: mud pack;Other: Sulfur water application<br>* Aplication the sulfur water in bath from 20 minutes<br>* Other names: Sulfur bath;Other: Hygienic water<br>* Exercise in hygienic water<br>* Other names: Exercise in hygienic water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The serotonin levels | Serotonin concentration | Time Frame: Baseline vs. 12-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marker of inflammation | Sedimentation concentration | Time Frame: Baseline vs. 12-days | 
| Analysis of hemoglobin | Concentration of hemoglobin (g/L) | Time Frame: Baseline vs. 12-days | 
| Analysis of red blood cell counts | The total number of erythrocytes / L | Time Frame: Baseline vs. 12-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, balneotherapy, mud therapy, sulfuric water, serotonin