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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Kneippsche Stiftungen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Otto-Schönfisch Foundation/ Bad Wörishofen/ Germany
Information provided by:
Kneippsche Stiftungen
ClinicalTrials.gov Identifier:
NCT00950326
First received: July 29, 2009
Last updated: July 30, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Hip or Knee
Procedure: Physiotherapy
Procedure: Affusion
Procedure: Affusion/ Physiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kneippsche Stiftungen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950326

Locations
Germany
Kneipp-Clinic Recruiting
Bad Wörishofen, Bavaria, Germany, D- 86825
Contact: Martin Schencking, MD    0049-1718121516    naturedoc@web.de   
Contact: Hagen Sandholzer, MD, PhD    0049-341-9715710    haeb@medizin.uni-leipzig.de   
Sub-Investigator: Hagen Sandholzer, MD, PhD         
Principal Investigator: Martin Schencking, MD         
Sponsors and Collaborators
Kneippsche Stiftungen
Otto-Schönfisch Foundation/ Bad Wörishofen/ Germany
Investigators
Principal Investigator: Martin Schencking, MD Head of department, Kneipp-Clinic, Bad Wörishofen
  More Information

No publications provided by Kneippsche Stiftungen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kneippsche Stiftungen/ Bad Wörishofen
ClinicalTrials.gov Identifier: NCT00950326     History of Changes
Other Study ID Numbers: OSF
Study First Received: July 29, 2009
Last Updated: July 30, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Kneippsche Stiftungen:
osteoarthritis
hydrotherapy
affusion
conventional physiotherapy
comparison

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014