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

NCT00950326 | Unknown Phase 1 DMC

• 1 other identifier: OSF
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis of the Hip or Knee

Keywords

osteoarthritis; hydrotherapy; affusion; conventional physiotherapy; comparison

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

B1-Physio

ACTIVE COMPARATOR

In Group B1, patients will be given physiotherapy of the hip or knee joint three times a week

Procedure: Physiotherapy

A1 Hydro

EXPERIMENTAL

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

C- Hydro & Physiotherapy

ACTIVE COMPARATOR

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

Interventions

Physiotherapy PROCEDURE

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.

B1-Physio

Affusion PROCEDURE

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.

A1 Hydro

Affusion/ Physiotherapy PROCEDURE

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).

C- Hydro & Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kneippsche Stiftungen: lead
• Otto-Schönfisch Foundation/ Bad Wörishofen/ Germany: collaborator

Study Sites (1)

Kneipp-Clinic

Bad Wörishofen, Bavaria, D- 86825, Germany

RECRUITING

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  PMID: 23464642 DERIVED

• 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.

  PMID: 19689824 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Martin Schencking, MD

  Head of department, Kneipp-Clinic, Bad Wörishofen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 31, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 31, 2009

Record last verified: 2009-07

Locations

DE (1)