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

NCT ID: NCT04192162

Last Updated: 2019-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2020-09-01

Brief 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.

Detailed 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.

Conditions

Osteoarthritis of Multiple Joints

Keywords

osteoarthritis; balneotherapy; mud therapy; sulfuric water; serotonin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group of sulfur balneotherapy and mud pack therapy

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.

Group Type: EXPERIMENTAL

Mud therapy application

Intervention Type: OTHER

Aplication the mud pack therapy from 20 minutes

Sulfur water application

Intervention Type: OTHER

Aplication the sulfur water in bath from 20 minutes

Group of sulfur balneotherapy, mud pack therapy and exercise

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.

Group Type: ACTIVE_COMPARATOR

Mud therapy application

Intervention Type: OTHER

Aplication the mud pack therapy from 20 minutes

Sulfur water application

Intervention Type: OTHER

Aplication the sulfur water in bath from 20 minutes

Hygienic water

Intervention Type: OTHER

Exercise in hygienic water

Interventions

Mud therapy application

Aplication the mud pack therapy from 20 minutes

Intervention Type: OTHER

Sulfur water application

Aplication the sulfur water in bath from 20 minutes

Intervention Type: OTHER

Hygienic water

Exercise in hygienic water

Intervention Type: OTHER

Other Intervention Names

mud pack; Sulfur bath; Exercise in hygienic water

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Specialized Rehabilitation Hospital Banja Koviljaca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksandar M Jokić

Role: PRINCIPAL_INVESTIGATOR

Specijalna bolnica za rehabilitaciju Banja Koviljača

Locations

Specializd Rehabilitation Hospital Banja Koviljaca

Loznica, Banja Koviljaca, Serbia

Site Status: RECRUITING

Countries

Serbia

Central Contacts

Aleksandar M Jokić

Role: CONTACT

Phone: +381648731317

Email: jokic71@gmail.com

Aleksandra B Jovanović

Role: CONTACT

Phone: +381658265992

Email: marketing@banjakoviljaca.rs

Facility Contacts

Aleksandar M Jokić

Role: primary

Other Identifiers

SRH BanjaKoviljaca

Identifier Type: -

Identifier Source: org_study_id