Clinical trial NCT06424782: Therapeutic Effect of the Natural Mineral Water of the Well B-308 OKK in Győr (Gyirmót) on Knee Osteoarthrosis
Official 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: medicinal water
healing water
balneotherapy
WOMAC
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: Gyirmót Sport & Wellness Hotel
First posted: 2024-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from the baseline in range of motion of the knee measured with goniometer at week 3 and 12
timeFrame: Baseline and week 3 and 12
measure: 30-second Chair Stand Test
timeFrame: Baseline and week 3 and 12
measure: Timed Up and Go (TUG)
timeFrame: Baseline and week 3 and 12
measure: Change from baseline in pain on the 10-point Visual Analogue Scale (VAS) at week 3 and 12
timeFrame: Baseline and week 3 and 12
measure: Change from baseline in functional status with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) index at week 3 and 12
timeFrame: Baseline and week 3 and 12
measure: Change from baseline in quality of life with the Short Form 36 Health Survey Questionnaire (SF-36) at week 3 and 12
timeFrame: Baseline and week 3 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Katalin Dr Szendi
state: Baranya
Study officials:
affiliation: University of Pecs
name: Adrienn Hanzel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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