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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое medicinal water
  Medicinal water treatment in bath tub once daily.

Первичные конечные точки

• Change from the baseline in range of motion of the knee measured with goniometer at week 3 and 12 [Срок оценки: Baseline and week 3 and 12]
• 30-second Chair Stand Test [Срок оценки: Baseline and week 3 and 12]
• Timed Up and Go (TUG) [Срок оценки: Baseline and week 3 and 12]
• Change from baseline in pain on the 10-point Visual Analogue Scale (VAS) at week 3 and 12 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline and week 3 and 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Венгрия · 1 центр

• Katalin Dr Szendi — Pécs

Публикации

• 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 2 PMID 14644851
• 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 R PMID 23595142
• 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. PMID 24594851
• 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. PMID 28457097
• 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. PMID 28682652
• 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. PMID 23677421
• 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. PMID 29327104
• 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. PMID 29102940

Идентификаторы

NCT: NCT06424782 · B-308 OKK

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗