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

University of Pecs

Status: Not yet enrolling

Conditions: Knee Osteoarthritis

Treatments: Other: medicinal water

Study type: Interventional

Funder types: Other

Identifiers

NCT06424782

B-308 OKK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Medicinal water treatment

Experimental group

Description:

Participants receive medicinal water treatment in bath tub once daily (30 min) on weekdays for 3 weeks.

Treatment:

Other: medicinal water

Tap water (placebo) treatment

Placebo Comparator group

Description:

Participants receive placebo water treatment in bath tub once daily (30 min) on weekdays for 3 weeks.

Treatment:

Other: medicinal water