A Comparison of Kneipp Hydrotherapy With Conventional Physiotherapy in the Treatment of Osteoarthritis of the Hip or Knee: Protocol of a Prospective Randomised Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be the pain intensity of the affected joint during inpatient care, as assessed by the patient and the investigator
研究概览
简要总结
The study design consists of a prospective randomised controlled three-armed clinical trial, which will be carried out at a specialist clinic for integrative medicine, to investigate the clinical effects of hydrotherapy on osteoarthritis of the knee or hip joint, in comparison with conventional physiotherapy.
详细描述
The main aim of this three-armed clinical study will be to determine the effects of hydrotherapy with alternate cold and warm affusions of the thigh in the concomitant treatment of osteoarthritis of the hip or knee. The main outcome measures are pain reduction, improvement in the quality of life, and increased movement in the affected joint.
Research questions
- Does Kneipp hydrotherapy show a measurable effect in the sense of altered clinical findings in the affected knee or hip joint?
- How effectively does hydrotherapy influence the clinical parameters of pain, range of movement, and function of the affected joint?
- How effectively does hydrotherapy affect the secondary outcome measures of quality of life, pain experienced, mood, and blood pressure?
- Do hydrotherapeutic applications simply provide short-term therapeutic success or are there long-term changes in the clinical findings?
- Are the clinical effects of hydrotherapy comparable with those of conventional physiotherapy of the affected joint?
- Are the clinical effects of hydrotherapy used as monotherapy comparable with a combination of hydrotherapy and physiotherapy of the affected joint?
- Do unwanted effects or side effects occur with hydrotherapy?
This study was designed as a prospective randomised controlled clinical trial with three arms, which is to be carried out at a German clinic specialised in integrative medicine, to investigate the clinical effects of hydrotherapy on osteoarthritis of the knee or hip, as compared with conventional physiotherapy.
To achieve maximum scientific accuracy with respect to randomisation, random distribution, avoidance of selection bias, etc., the independent Department of General Medicine and Primary Care of the University of Leipzig Medical School will function as an external evaluation and testing centre.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Symptomatic osteoarthritis of hip or knee (following the revised criteria of the American College of Rheumatology)
- •Willingness to comply with follow-up assessments and treatment
- •Ability to understand, read and speak German
排除标准
- •Endoprothetic replacement of hip or knee joint
- •Inflammatory arthropathy of the hip or the knee
- •Acute, hot, red and swollen knee or hip joint (unknown focus)
- •Inflammatory system diseases which could interfere with the evaluation of the therapy procedure
- •CNS diseases, especially epilepsy
- •Anamnesis of deep vein thrombosis in the past 12 months
- •Severe lung disease such as e.g. COPD stages GOLD III - GOLD IV
- •Heart failure NYHA III - NYHA IV
- •Myocardial ischemia with or without intervention within the last 3 months before inpatient admission
- •Cancer in advanced stage
- •Large skin wounds or inflammatory and ulcerated dermatosis of the legs
- •Severe febrile infectious diseases
- •Non treated hypertension
- •Participation in another clinical study within the past four weeks
- •Pregnancy
研究组 & 干预措施
B1-Physio
In Group B1, patients will be given physiotherapy of the hip or knee joint three times a week
干预措施: Physiotherapy (Procedure)
A1 Hydro
In this group patients will receive a specific hydrotherapeutic procedure in the form of alternate cold and warm thigh affusions ( pouring on water) which will consist of repeated cold and warm water stimulation of the knee and hip region.
干预措施: Affusion (Procedure)
C- Hydro & Physiotherapy
Patients with active osteoarthritis of the hip or knee will receive specific, joint-related hydrotherapy in the form of a (daily) alternate cold and warm thigh affusions as well as joint-specific physiotherapy (three times a week).
干预措施: Affusion/ Physiotherapy (Procedure)
结局指标
主要结局
The primary outcome measure will be the pain intensity of the affected joint during inpatient care, as assessed by the patient and the investigator
时间窗: 2 Years
次要结局
- I) Mobility of the affected joint II) Quality of life rating for the patient with osteoarthritis, on the basis of the German version of the Arthritis Impact Measurement Scale (AIMS2)(2 Years)