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

July 30, 2009 updated by: Kneippsche Stiftungen
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

  1. Does Kneipp hydrotherapy show a measurable effect in the sense of altered clinical findings in the affected knee or hip joint?
  2. How effectively does hydrotherapy influence the clinical parameters of pain, range of movement, and function of the affected joint?
  3. How effectively does hydrotherapy affect the secondary outcome measures of quality of life, pain experienced, mood, and blood pressure?
  4. Do hydrotherapeutic applications simply provide short-term therapeutic success or are there long-term changes in the clinical findings?
  5. Are the clinical effects of hydrotherapy comparable with those of conventional physiotherapy of the affected joint?
  6. Are the clinical effects of hydrotherapy used as monotherapy comparable with a combination of hydrotherapy and physiotherapy of the affected joint?
  7. 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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Bad Wörishofen, Bavaria, Germany, D- 86825
        • Recruiting
        • Kneipp-Clinic
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hagen Sandholzer, MD, PhD
        • Principal Investigator:
          • Martin Schencking, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B1-Physio
In Group B1, patients will be given physiotherapy of the hip or knee joint three times a week
Procedure: Physiotherapy
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.
Experimental: 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.
Procedure: Affusion
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.
Active Comparator: 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).
Procedure: Affusion/ 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 2 Years
2 Years

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: 2 Years
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kneippsche Stiftungen

Collaborators

Otto-Schönfisch Foundation/ Bad Wörishofen/ Germany

Investigators

  • Principal Investigator: Martin Schencking, MD, Head of department, Kneipp-Clinic, Bad Wörishofen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

July 31, 2009

Last Update Submitted That Met QC Criteria

July 30, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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