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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Medicinal water treatment in bath tub once daily.
Katalin Dr Szendi
Pécs, Baranya, Hungary
Change from the baseline in range of motion of the knee measured with goniometer at 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)
Time frame: Baseline and week 3 and 12
30-second Chair Stand Test
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)
Time frame: Baseline and week 3 and 12
Timed Up and Go (TUG)
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)
Time frame: Baseline and week 3 and 12
Change from baseline in pain on the 10-point Visual Analogue Scale (VAS) at 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)
Time frame: 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
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)
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Time frame: 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
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)
Time frame: Baseline and week 3 and 12