Therapeutic Effect of the Natural Mineral Water of the Well B-308 OKK in Győr (Gyirmót) on Knee Osteoarthrosis

May 16, 2024 updated by: University of Pecs

Investigation of the Therapeutic Effect of the Natural Mineral Water of the Well B-308 OKK in Győr (Gyirmót) Among People With Knee Arthrosis (Randomized, Controlled, Double-blind, Follow-up Study)

The main purpose of the study is to investigate the therapeutic effect of the thermal water of Győr (Gyirmót) well No. B-308 OKK on patients with knee arthrosis, and to compare its therapeutic effect with tap water (placebo) group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and the potential risks, all patients giving written informed consent will undergo a continuous screening period, until the number of 25-25 patients is reached, to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to medicinal water or placebo group.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Katalin Dr Szendi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Knee osteoarthrosis that has existed for at least 3 months
  • Age between 50 and 80 years
  • Willingness to participate in 3-week outpatient rehabilitation treatment
  • Pain in the knee joint lasting at least 3 months and at least 5 days a week
  • At least mild pain during selection (1 point on the Likert scale)
  • Does not have a serious disability

Exclusion Criteria:

  • Any kind of physiotherapy treatment in the last 2 months (except home gymnastics)
  • Any previous knee joint surgery
  • Any trauma to the knee or hip joint in the 1 year prior to the examination
  • Knee arthroscopy performed within 3 months prior to the examination
  • Intra-articular corticosteroid treatment of the affected knee in the last 3 months
  • Palpable Baker's cyst
  • Any hip joint or spine surgery within a year before the examination
  • Intra-articular hyaluronic injection within 2 months before the examination
  • Appearance of lumbar radiculopathy
  • Presence of serious internal medicine disease, urogenital or other diseases
  • Uncooperative or psychoneurotic patients
  • Lumbago, sciatica; and any other surgery or previous fracture in the hip joint
  • Subluxation, luxation, algodystrophy, fibromyalgia, gout
  • Balneotherapy in the last 6 months
  • Systemic corticosteroid treatment in 1 month before the examination
  • Starting the treatment of osteoarthritis SYSADOA (symptomatic slow-acting drugs for osteoarthritis) in 3 months before the examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medicinal water treatment
Participants receive medicinal water treatment in bath tub once daily (30 min) on weekdays for 3 weeks.
Other: medicinal water
Medicinal water treatment in bath tub once daily.
Placebo Comparator: Tap water (placebo) treatment
Participants receive placebo water treatment in bath tub once daily (30 min) on weekdays for 3 weeks.
Other: medicinal water
Medicinal water treatment in bath tub once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the baseline in range of motion of the knee measured with goniometer at week 3 and 12
Time Frame: Baseline and week 3 and 12
Goniometer is a range of motion measuring device. Its measuring range is 180 degrees. Change = (Week 3 degree - Baseline degree), Change = (Week 12 degree - Baseline degree)
Baseline and week 3 and 12
30-second Chair Stand Test
Time Frame: Baseline and week 3 and 12
The test counts the number of times the patient comes to a full standing position in 30 seconds. Change = (Week 3 number - Baseline number), Change = (Week 12 number - Baseline number)
Baseline and week 3 and 12
Timed Up and Go (TUG)
Time Frame: Baseline and week 3 and 12
It is a simple test that measures how quickly you can stand up, walk 3 meters, turn around, walk back, and sit down. It is done to assess mobility in older adults or predict their risk of falls. Many healthy adults less than 80 years old can complete the TUG test in 10 seconds or less. Change = (Week 3 seconds - Baseline seconds), Change = (Week 12 seconds - Baseline seconds)
Baseline and week 3 and 12
Change from baseline in pain on the 10-point Visual Analogue Scale (VAS) at week 3 and 12
Time Frame: Baseline and week 3 and 12
The visual analogue scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Change = (Week 3 point - Baseline point), Change = (Week 12 point - Baseline point)
Baseline and week 3 and 12
Change from baseline in functional status with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) index at week 3 and 12
Time Frame: Baseline and week 3 and 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. Change = (Week 3 score - Baseline score), Change = (Week 12 score - Baseline score)
Baseline and week 3 and 12
Change from baseline in quality of life with the Short Form 36 Health Survey Questionnaire (SF-36) at week 3 and 12
Time Frame: Baseline and week 3 and 12
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). Scores ranges from 0 to 100. Higher scores indicate higher quality of life. Change = (Week 3 score - Baseline score), Change = (Week 12 score - Baseline score)
Baseline and week 3 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Collaborators

Gyirmót Sport & Wellness Hotel

Investigators

  • Principal Investigator: Adrienn Hanzel, Ph.D., University of Pecs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-308 OKK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The outcome measures as individual participant data can be shared. Outcome measures are the followings: range of motion, 30-second Chair Stand Test, Timed Up and Go (TUG), VAS scale, WOMAC index, SF-36 questionnaire

IPD Sharing Time Frame

April 2025 - December 2025

IPD Sharing Access Criteria

Data will be provided upon researcher request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on medicinal water

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe