NCT04192162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

December 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

November 12, 2019

Last Update Submit

December 18, 2019

Conditions

Osteoarthritis of Multiple Joints

Keywords

osteoarthritisbalneotherapymud therapysulfuric waterserotonin

Outcome Measures

Primary Outcomes (1)

  • The serotonin levels

    Serotonin concentration

    Time Frame: Baseline vs. 12-days

Secondary Outcomes (3)

  • Marker of inflammation

    Time Frame: Baseline vs. 12-days

  • Analysis of hemoglobin

    Time Frame: Baseline vs. 12-days

  • Analysis of red blood cell counts

    Time Frame: Baseline vs. 12-days

Study Arms (2)

Group of sulfur balneotherapy and mud pack therapy

EXPERIMENTAL

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 applicationOther: Sulfur water application

Group of sulfur balneotherapy, mud pack therapy and exercise

ACTIVE COMPARATOR

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 applicationOther: Sulfur water applicationOther: Hygienic water

Interventions

Mud therapy applicationOTHER

Aplication the mud pack therapy from 20 minutes

Also known as: mud pack
Group of sulfur balneotherapy and mud pack therapyGroup of sulfur balneotherapy, mud pack therapy and exercise
Sulfur water applicationOTHER

Aplication the sulfur water in bath from 20 minutes

Also known as: Sulfur bath
Group of sulfur balneotherapy and mud pack therapyGroup of sulfur balneotherapy, mud pack therapy and exercise
Hygienic waterOTHER

Exercise in hygienic water

Also known as: Exercise in hygienic water
Group of sulfur balneotherapy, mud pack therapy and exercise

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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…)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Specializd Rehabilitation Hospital Banja Koviljaca

Loznica, Banja Koviljaca, 15316, Serbia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Mud TherapyExercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

BalneologyTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aleksandar M Jokić

    Specijalna bolnica za rehabilitaciju Banja Koviljača

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandar M Jokić

CONTACT

+381648731317jokic71@gmail.com

Aleksandra B Jovanović

CONTACT

+381658265992marketing@banjakoviljaca.rs

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

December 10, 2019

Study Start

December 18, 2019

Primary Completion

April 18, 2020

Study Completion

September 1, 2020

Last Updated

December 20, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)