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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The design and concept of this study, as well as its ethical validity, were reviewed and approved by the Ethics Committee of the Bavarian State Chamber of Physicians [Ethikkommission der Bayerischen Landesärztekammer], (Study Number 08032, dated 04.05.2008). One hundred and eighty patients diagnosed with osteoarthritis of hip or knee will be randomly assigned to one of three intervention groups: hydrotherapy, physiotherapy, and both physiotherapy and hydrotherapy of the affected joint. In the first group, patients will receive Kneipp hydrotherapy daily, with water applied in the form of alternate cold and warm thigh affusions (alternating cold and warm water stimulation is particularly relevant to the knee and hip regions). Patients in the second group will receive physiotherapy of the hip or knee joint three times a week. Patients in the physiotherapy-hydrotherapy combination group will receive both joint-specific physiotherapy three times a week and alternate cold and warm thigh affusions every day.

Official Title
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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

Conditions
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Osteoarthritis of the Hip or Knee

Intervention / Treatment
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* Procedure: Physiotherapy
* Procedure: Affusion
* Procedure: Affusion/ Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B1-Physio<br>In Group B1, patients will be given physiotherapy of the hip or knee joint three times a week | Procedure: Physiotherapy<br>* In intervention group B1, patients with osteoarthritis of the hip or knee will receive specific physiotherapy of the affected hip or knee joint three times a week, but without any disease-specific hydrotherapy. Because of the holistic approach of the clinic, however, these patients will still receive hydrotherapy at sites other than the affected joint, for example, alternate cold and warm affusions of the back or an ascending lumbar affusion.<br>|
| Experimental: A1 Hydro<br>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. | Procedure: Affusion<br>* 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 (daily). Physiotherapy of other regions, such as the back, is permitted but there will be no specific physiotherapy of the hip or knee joint.<br>|
| Active Comparator: C- Hydro & Physiotherapy<br>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). | Procedure: Affusion/ Physiotherapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure will be the pain intensity of the affected joint during inpatient care, as assessed by the patient and the investigator |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, hydrotherapy, affusion, conventional physiotherapy, comparison