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

NCT ID: NCT06424782

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-09-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Medicinal water treatment

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

Group Type: EXPERIMENTAL

medicinal water

Intervention Type: OTHER

Medicinal water treatment in bath tub once daily.

Tap water (placebo) treatment

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

Group Type: PLACEBO_COMPARATOR

medicinal water

Intervention Type: OTHER

Medicinal water treatment in bath tub once daily.

Interventions

medicinal water

Medicinal water treatment in bath tub once daily.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gyirmót Sport & Wellness Hotel

UNKNOWN

Sponsor Role: collaborator

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrienn Hanzel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pecs

Locations

Katalin Dr Szendi

Pécs, Baranya, Hungary

Countries

Hungary

Central Contacts

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

Role: CONTACT

szkata82@yahoo.co.uk

+36702654095

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Other Identifiers

B-308 OKK

Identifier Type: -

Identifier Source: org_study_id