Osteoarthritis of the Hip or KneePhase 1/2NCT00950326
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
A Phase 1/2 study testing Physiotherapy, Affusion and Affusion/ Physiotherapy in people with Osteoarthritis of the Hip or Knee, run by Kneippsche Stiftungen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Hip or Knee
- What is being tested?
- Physiotherapy, Affusion and Affusion/ Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Kneipp-Clinic
Bad Wörishofen, Bavaria, D- 86825
Martin Schencking, MD, 0049-1718121516, naturedoc@web.de
Hagen Sandholzer, MD, PhD, 0049-341-9715710, haeb@medizin.uni-leipzig.de
About this study
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.
Read the 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
- 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.
- Conditions
- Osteoarthritis of the Hip or Knee
- Being tested
- Physiotherapy, Affusion, Affusion/ Physiotherapy
- Keywords
- osteoarthritis, hydrotherapy, affusion, conventional physiotherapy, comparison
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyProcedure or surgery
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.
AffusionProcedure or surgery
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/ PhysiotherapyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| B1-Physio | Active comparator | In Group B1, patients will be given physiotherapy of the hip or knee joint three times a week Receives: 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. Receives: 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). Receives: Procedure: Affusion/ Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the pain intensity of the affected joint during inpatient care, as assessed by the patient and the investigator
Measured: 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)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the Hip or KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kneippsche Stiftungen
- Sponsor type
- University, hospital or other
- Collaborators
- Otto-Schönfisch Foundation/ Bad Wörishofen/ Germany
- Investigators
- Martin Schencking, MD, Principal investigator, Head of department, Kneipp-Clinic, Bad Wörishofen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950326
- Sponsor's protocol ID
- OSF
- Status last verified
- Jul 2009
- First submitted
- 29 Jul 2009
- Last updated
- 31 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23464642Schencking 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.
PubMed 19689824
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00950326
- Acronym / sponsor ID
- OSF
- Conditions
- Osteoarthritis of the Hip or Knee
- Keywords
- osteoarthritis, hydrotherapy, affusion, conventional physiotherapy, comparison
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Kneippsche StiftungenUniversity, hospital or other
- Collaborators
- Otto-Schönfisch Foundation/ Bad Wörishofen/ Germany
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B1-Physio | Active comparator | Procedure: PhysiotherapyIn Group B1, patients will be given physiotherapy of the hip or knee joint three times a week |
| A1 Hydro | Experimental | Procedure: AffusionIn 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. |
| C- Hydro & Physiotherapy | Active comparator | Procedure: Affusion/ PhysiotherapyPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyIn 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. | Procedure or surgery | B1-Physio |
| AffusionPatients 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. | Procedure or surgery | A1 Hydro |
| Affusion/ PhysiotherapyPatients 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 or surgery | C- Hydro & Physiotherapy |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2009.
- Background1. 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.
- Derived from this study: PubMed 23464642Schencking 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.
- Derived from this study: PubMed 19689824Schencking 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schencking, MD principal investigator
Head of department, Kneipp-Clinic, Bad Wörishofen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Physiotherapy, Affusion and Affusion/ Physiotherapy in people with Osteoarthritis of the Hip or Knee, run by Kneippsche Stiftungen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00950326, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2009.