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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from the baseline in range of motion of the knee measured with goniometer at week 3 and 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from the baseline in range of motion of the knee measured with goniometer at week 3 and 12
时间窗: Baseline and 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)
Timed Up and Go (TUG)
时间窗: Baseline and week 3 and 12
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)
Change from baseline in pain on the 10-point Visual Analogue Scale (VAS) at week 3 and 12
时间窗: Baseline and 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)
Change from baseline in functional status with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) index at week 3 and 12
时间窗: Baseline and 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)
Change from baseline in quality of life with the Short Form 36 Health Survey Questionnaire (SF-36) at week 3 and 12
时间窗: Baseline and 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)
30-second Chair Stand Test
时间窗: Baseline and week 3 and 12
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)
次要结局
未报告次要终点