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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis of Multiple Joints
• Intervention / Treatment: Other: Mud therapy application; Other: Sulfur water application; Other: Hygienic water

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Banja Koviljaca
    • Loznica, Banja Koviljaca, Serbia, 15316
      • Recruiting
      • Specializd Rehabilitation Hospital Banja Koviljaca
      • Contact: Aleksandar M Jokić; Phone Number: +381648731317; Email: jokic71@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Mud therapy application; Aplication the mud pack therapy from 20 minutes; Other Names: mud pack; Other: Sulfur water application; Aplication the sulfur water in bath from 20 minutes; Other Names: Sulfur bath
Active Comparator: 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.	Other: Mud therapy application; Aplication the mud pack therapy from 20 minutes; Other Names: mud pack; Other: Sulfur water application; Aplication the sulfur water in bath from 20 minutes; Other Names: Sulfur bath; Other: Hygienic water; Exercise in hygienic water; Other Names: Exercise in hygienic water

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Specialized Rehabilitation Hospital Banja Koviljaca
• Investigators: Principal Investigator: Aleksandar M Jokić, Specijalna bolnica za rehabilitaciju Banja Koviljača

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Anticipated): April 18, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: osteoarthritis; serotonin; balneotherapy; mud therapy; sulfuric water
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: SRH BanjaKoviljaca

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No