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

Osteoarthritis of Multiple Joints Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192162
• Other study ID #: SRH BanjaKoviljaca
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: December 2019
• Source: Specialized Rehabilitation Hospital Banja Koviljaca
• Contact: Aleksandar M Jokic
• Phone: +381648731317
• Email: jokic71[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2020
• Est. primary completion date: April 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Ages of 50 - 65 , both sexes

2. Patients diagnosed with hip and / or knee OA without having used balneotherapy in the previous year

3. Patients who have not changed their medication in the last 2 months

4. Patients who have not received injections into the hip and / or knee joint in the last 6 months (PRP, Diprofos…)

Exclusion Criteria:

1. Secondary hip and / or knee OA

2. Patients with MOA inhibitors, selective serotonin inhibitors, morphine, lithium and methyldopa in therapy

3. Visible disruption of hip and / or knee joint structures

4. Treatment of malignancy

5. Diseases of the heart, lungs, decompensated conditions of other organs, infections, active bleeding

6. Severe hip and / or knee joint injuries, fractures, and previous surgical procedures

7. Physical therapy, balneotherapy back one year

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Multiple Joints

Intervention

Other:
• Mud therapy application
Aplication the mud pack therapy from 20 minutes
• Sulfur water application
Aplication the sulfur water in bath from 20 minutes
• Hygienic water
Exercise in hygienic water

Locations

Country	Name	City	State
Serbia	Specializd Rehabilitation Hospital Banja Koviljaca	Loznica	Banja Koviljaca

Sponsors (1)

Lead Sponsor	Collaborator
Specialized Rehabilitation Hospital Banja Koviljaca

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The serotonin levels	Serotonin concentration	Time Frame: Baseline vs. 12-days
Secondary	Marker of inflammation	Sedimentation concentration	Time Frame: Baseline vs. 12-days
Secondary	Analysis of hemoglobin	Concentration of hemoglobin (g/L)	Time Frame: Baseline vs. 12-days
Secondary	Analysis of red blood cell counts	The total number of erythrocytes / L	Time Frame: Baseline vs. 12-days