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

Primary Purpose

Osteoarthritis of Multiple Joints

Status
Unknown status
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Mud therapy application
Sulfur water application
Hygienic water
Sponsored by
Specialized Rehabilitation Hospital Banja Koviljaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Multiple Joints focused on measuring osteoarthritis, balneotherapy, mud therapy, sulfuric water, serotonin

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Specializd Rehabilitation Hospital Banja KoviljacaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group of sulfur balneotherapy and mud pack therapy

Group of sulfur balneotherapy, mud pack therapy and exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The serotonin levels
Serotonin concentration

Secondary Outcome Measures

Marker of inflammation
Sedimentation concentration
Analysis of hemoglobin
Concentration of hemoglobin (g/L)
Analysis of red blood cell counts
The total number of erythrocytes / L

Full Information

First Posted
November 12, 2019
Last Updated
December 18, 2019
Sponsor
Specialized Rehabilitation Hospital Banja Koviljaca
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1. Study Identification

Unique Protocol Identification Number
NCT04192162
Brief Title
Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis
Official Title
Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
April 18, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Specialized Rehabilitation Hospital Banja Koviljaca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Multiple Joints
Keywords
osteoarthritis, balneotherapy, mud therapy, sulfuric water, serotonin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group of sulfur balneotherapy and mud pack therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Group of sulfur balneotherapy, mud pack therapy and exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mud therapy application
Other Intervention Name(s)
mud pack
Intervention Description
Aplication the mud pack therapy from 20 minutes
Intervention Type
Other
Intervention Name(s)
Sulfur water application
Other Intervention Name(s)
Sulfur bath
Intervention Description
Aplication the sulfur water in bath from 20 minutes
Intervention Type
Other
Intervention Name(s)
Hygienic water
Other Intervention Name(s)
Exercise in hygienic water
Intervention Description
Exercise in hygienic water
Primary Outcome Measure Information:
Title
The serotonin levels
Description
Serotonin concentration
Time Frame
Time Frame: Baseline vs. 12-days
Secondary Outcome Measure Information:
Title
Marker of inflammation
Description
Sedimentation concentration
Time Frame
Time Frame: Baseline vs. 12-days
Title
Analysis of hemoglobin
Description
Concentration of hemoglobin (g/L)
Time Frame
Time Frame: Baseline vs. 12-days
Title
Analysis of red blood cell counts
Description
The total number of erythrocytes / L
Time Frame
Time Frame: Baseline vs. 12-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandar M Jokić
Phone
+381648731317
Email
jokic71@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandra B Jovanović
Phone
+381658265992
Email
marketing@banjakoviljaca.rs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandar M Jokić
Organizational Affiliation
Specijalna bolnica za rehabilitaciju Banja Koviljača
Official's Role
Principal Investigator
Facility Information:
Facility Name
Specializd Rehabilitation Hospital Banja Koviljaca
City
Loznica
State/Province
Banja Koviljaca
ZIP/Postal Code
15316
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandar M Jokić
Phone
+381648731317
Email
jokic71@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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