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

Knee Osteoarthritis Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424782
• Other study ID #: B-308 OKK
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: University of Pecs
• Contact: Katalin Szendi, M.D., Ph.D.
• Phone: +36702654095
• Email: szkata82[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• medicinal water
Medicinal water treatment in bath tub once daily.

Locations

Country	Name	City	State
Hungary	Katalin Dr Szendi	Pécs	Baranya

Sponsors (2)

Lead Sponsor	Collaborator
University of Pecs	Gyirmót Sport & Wellness Hotel

Country where clinical trial is conducted

Hungary, 

References & Publications (10)

Ayan C, Carvalho P, Varela S, Cancela JM. Effects of Water-Based Exercise Training on the Cognitive Function and Quality of Life of Healthy Adult Women. J Phys Act Health. 2017 Nov 1;14(11):899-904. doi: 10.1123/jpah.2017-0036. Epub 2017 Sep 25. — View Citation

Bender T, Balint G, Prohaszka Z, Geher P, Tefner IK. Evidence-based hydro- and balneotherapy in Hungary--a systematic review and meta-analysis. Int J Biometeorol. 2014 Apr;58(3):311-23. doi: 10.1007/s00484-013-0667-6. Epub 2013 May 16. — View Citation

Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17. — View Citation

Gutenbrunner C, Bender T, Cantista P, Karagulle Z. A proposal for a worldwide definition of health resort medicine, balneology, medical hydrology and climatology. Int J Biometeorol. 2010 Sep;54(5):495-507. doi: 10.1007/s00484-010-0321-5. Epub 2010 Jun 9. — View Citation

Gyarmati N, Kulisch A, Nemeth A, Bergmann A, Horvath J, Mando Z, Matan A, Szakal E, Sasne Peter T, Szanto D, Bender T. Evaluation of the Effect of Heviz Mud in Patients with Hand Osteoarthritis: A Randomized, Controlled, Single-Blind Follow-Up Study. Isr Med Assoc J. 2017 Mar;19(3):177-182. — View Citation

Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742. — View Citation

Karagulle M, Kardes S, Karagulle MZ. Long-term efficacy of spa therapy in patients with rheumatoid arthritis. Rheumatol Int. 2018 Mar;38(3):353-362. doi: 10.1007/s00296-017-3926-8. Epub 2018 Jan 11. — View Citation

Kulisch A, Benko A, Bergmann A, Gyarmati N, Horvath H, Kranicz A, Mando ZS, Matan A, Nemeth A, Szakal E, Szanto D, Szekeres L, Bender T. Evaluation of the effect of Lake Heviz thermal mineral water in patients with osteoarthritis of the knee: a randomized, controlled, single-blind, follow-up study. Eur J Phys Rehabil Med. 2014 Aug;50(4):373-81. Epub 2014 Mar 5. — View Citation

McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24. — View Citation

Peter I, Jagicza A, Ajtay Z, Boncz I, Kiss I, Szendi K, Kustan P, Nemeth B. Balneotherapy in Psoriasis Rehabilitation. In Vivo. 2017 Nov-Dec;31(6):1163-1168. doi: 10.21873/invivo.11184. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline and week 3 and 12
Primary	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)	Baseline and week 3 and 12
Primary	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)	Baseline and week 3 and 12
Primary	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)	Baseline and week 3 and 12
Primary	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)	Baseline and week 3 and 12
Primary	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)	Baseline and week 3 and 12