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
NCT ID: NCT00950326
Last Updated: 2009-07-31
Study Results
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Basic Information
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UNKNOWN
PHASE1/PHASE2
180 participants
INTERVENTIONAL
2009-01-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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).
B1-Physio
In Group B1, patients will be given physiotherapy of the hip or knee joint three times a week
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.
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.
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.
Interventions
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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.
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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Otto-Schönfisch Foundation/ Bad Wörishofen/ Germany
UNKNOWN
Kneippsche Stiftungen
OTHER
Responsible Party
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Kneippsche Stiftungen/ Bad Wörishofen
Principal Investigators
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Martin Schencking, MD
Role: PRINCIPAL_INVESTIGATOR
Head of department, Kneipp-Clinic, Bad Wörishofen
Locations
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Kneipp-Clinic
Bad Wörishofen, Bavaria, Germany
Countries
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Facility Contacts
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Martin Schencking, MD
Role: primary
Hagen Sandholzer, MD, PhD
Role: backup
References
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1. Buckwalter JA, Saltzman C, Brown T: The impact of osteoarthritis: implications for research. Clin Orthop Relat Res 2004;S6-15. 2. Aigner T, Rose J, Martin J, Buckwalter J: Aging theories of primary osteoarthritis: from epidemiology to molecular biology. Rejuvenation Res 2004;7:134-145. 3. Lohmander LS, Gerhardsson d, V, Rollof J, Nilsson PM, Engstrom G: Incidence of severe knee and hip osteoarthritis in relation to different measures of body mass: a population-based prospective cohort study. Ann Rheum Dis 2009;68:490-496. 4. Bijlsma JW, Knahr K: Strategies for the prevention and management of osteoarthritis of the hip and knee. Best Pract Res Clin Rheumatol 2007;21:59-76. 5. Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AMK, Hochberg M: Effectiveness of Acupuncture as Adjunctive Therapy in Osteoarthritis of the Knee. Ann intern Med. 2004; 141:901-910 6. Leardini G, Mascia MT, Stisi S, Sandri G, Franceschini M: [Sanitary costs of osteoarthritis]. Reumatismo 2001;53:316-322. 7. Solignac M: [COART France 2003 report on new socioeconomic data on osteoarthritis in France]. Presse Med 2004;33:S4-S6. 8. Zochling J, March L, Lapsley H, Cross M, Tribe K, Brooks P: Use of complementary medicines for osteoarthritis--a prospective study. Ann Rheum Dis 2004;63:549-554.
Schencking M, Wilm S, Redaelli M. A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis: a pilot trial. J Integr Med. 2013 Jan;11(1):17-25. doi: 10.3736/jintegrmed2013004.
Schencking M, Otto A, Deutsch T, Sandholzer H. 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. BMC Musculoskelet Disord. 2009 Aug 19;10:104. doi: 10.1186/1471-2474-10-104.
Other Identifiers
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OSF
Identifier Type: -
Identifier Source: org_study_id