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NCT Number: NCT06424782

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Katalin Dr Szendi

Pécs, Baranya, 7624, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medicinal water

Other

Medicinal water treatment in bath tub once daily.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Katalin Szendi, M.D., Ph.D.

CONTACT

[email protected]

+36702654095

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Collaborators

  • Gyirmót Sport & Wellness Hotel

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 22, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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