Double-blind Randomized Controlled Clinical Trial for Evaluating the Effects of Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 88
- 主要终点
- Change of knee pain as assessed by Visual Analogue Scale
研究概览
简要总结
The aim of the study is the evaluation of the effect of balneotherapy with Acquabios bicarbonate-alkaline-sodium thermal water in ameliorating some signs and symptoms of knee osteoarthritis in human subjects suffering from this disease
详细描述
This double-blind randomized controlled clinical trial is aimed to evaluate whether the balneotherapy with Acquabios thermal water is effective in improving some signs and symptoms of gonarthrosis in subjects affected by this disease.
The evaluated outcomes will be the reduction of pain and muscle-joint stiffness, the improvement of the joint range, the improvement of the quality of life, strength in the lower limbs and tolerance to physical exercise, the quality of walking and function in specific daily activities compared to the control group. Appropriated and validated tests will be used to evaluate the achievement of these outcomes.
The evaluation will be carried out on all patients enrolled in the study at the beginning, after the first week of treatment, after the second week of treatment and at the end of the study period (90 days after the first day of treatment). All eligible patients will be evaluated at the time of selection for weight, height, blood pressure, heart rate. These parameters will be evaluated and recorded on a specific form both during the enrollment and during all the visits planned for the follow-up. Each visit will last approximately 30 minutes.
The adverse reactions known for the balneotherapy with thermal water are the temporary reduction or increase of blood pression, thermal crisis and thermal reaction.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of right knee osteoarthritis
- •Presence of pain characteristic of osteoarthritis of the right knee joint for at least 3 months
- •Absence of severe disability
- •Consent to treatment and participation in the study
排除标准
- •Bilateral knee osteoarthrosis or left knee osteoarthritis
- •Not eligilble for thermal balneotherapy treatments
- •Previous arthroprotesis
- •Previous balneotherapy treatments in last six months
- •One or more steroid treatments in last two months
- •One or more chondroprotective treatments, including infiltration with hyaluronic acid and similar in last six months
- •One or more physiotherapy treatments in last two months, with the exception of exercises carried out individually at home
- •Treatment with non-steroidal anti-inflammatory drugs in the last week
- •One or more surgery on the lower limbs
- •One or more trauma to the knee joint in the last 12 months
- •Knee joint instability and / or intra-articular effusion before or during study participation
- •Presence of palpable Baker's cyst
- •Severe psychiatric or neurological conditions
- •Being affected by severe chronic diseases: cardiovascular, respiratory, hepatic, cerebral, renal, juvenile diabetes, complicated diabetes mellitus, phlebopathies, systemic blood diseases, neoplasms
- •Ongoing rheumatic diseases
- •Being pregnant or breastfeeding
- •Being suffering from severe acute pathologies
结局指标
主要结局
Change of knee pain as assessed by Visual Analogue Scale
时间窗: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2),and after 3 months (T3) from the beginning of the study
Knee pain change measured by the use of Visual Analogue Scale (VAS). VAS scale consists of a straight line segment (100 mm) at the ends of which there are the indications "no pain" (0 mm) and "the strongest pain imaginable" (100 mm). The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (best, 0) to the right (worst, 100).
Change of knee joint stiffness as assessed by Western Ontario and McMaster Universities.(WOMAC) osteoarthritis index
时间窗: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
Knee joint stiffness change assessed by Western Ontario and McMaster Universities.(WOMAC) osteoarthritis index, a self-administered questionnaire. WOMAC questionnaire consists of 24 items divided into 3 subscales characterizing the patient's state of health: pain, joint stiffness and functionality. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
Change of knee range of motion change as assessed by the use of a universal goniometer
时间窗: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
Knee range of motion change measured by the use of a universal goniometer
Change of walking quality as assessed by the 6-meters Walking Test.
时间窗: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
Walking quality assessed by the 6-meters Walking Test, that evaluates the functional ability of walking by measuring the time required to walk 6 meters at a brisk pace. Each participants will be timed from the moment their foot cross the start line to the moment their foot cross the stop line placed at 6 meters from starting line.
Change of walking quality as assessed by Western Ontario and McMaster Universities (WOMAC) osteoarthritis score.
时间窗: At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study
Change of walking quality assessed by Western Ontario and McMaster Universities (WOMAC) osteoarthritis score. WOMAC questionnaire consists of 24 items divided into 3 subscales characterizing the patient's state of health: pain, joint stiffness and functionality. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
次要结局
- Change of quality of life as assessed by 36-Item Short Form Survey (SF-36) questionnaire(At baseline (T0) and after 3 months (T3) from the beginning of the study)
- Change of lower limbs strength as assessed by 30-seconds Chair Stand Test (30-s CST)(At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study)
研究者
Mario Fontana
Prof
University of Roma La Sapienza