Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 18, 2011 | ||||
| Last Updated Date | January 18, 2011 | ||||
| Start Date ICMJE | April 2011 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in Womac [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] The primary outcome measure is the patients' evaluation of improvement on the visual analogue scale of the WOMAC indices for pain and activities of daily life, comparing baseline and post-treatment. The secondary outcome measures summarized in the appendices will also be assessed at baseline and after 6, 12, and 26 weeks |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis | ||||
| Official Title ICMJE | Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Coxarthrosis: a Randomized, Controlled Study | ||||
| Brief Summary | Osteoarthritis (OA) is the most common degenerative arthropathy. Load-bearing joints such as knee and hip are more often affected than spine or hands. The prevalence of gonarthrosis is generally higher than that of coxarthrosis. Because no cure for OA exists, the main emphasis of therapy is analgesic treatment through either mobility or medication. Non-pharmacologic treatment is the first step, followed by the addition of analgesic medication, and ultimately by surgery. The goal of non-pharmacologic and non-invasive therapy is to improve neuromuscular function, which in turn both prevents formation of and delays progression of OA. A modification of conventional physiotherapy, whole body vibration has been successfully employed for several years. Since its introduction, this therapy is in wide use at our facility not only for gonarthrosis, but also coxarthrosis and other diseases leading to muscular imbalance. |
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| Detailed Description | This study is a randomized, therapy-controlled trial in a primary care setting at a university hospital. Patients presenting to our outpatient clinic with initial symptoms of coxarthrosis will be assessed against inclusion and exclusion criteria. After patient consent, 6 weeks of treatment will ensue. During the six weeks of treatment, patients will receive one of two treatments, conventional physiotherapy or whole-body-vibration exercises of one hour three times a week. Follow-up examinations will be performed immediately after treatment and after another 6 and 20 weeks, for a total study duration of 6 months. 20 patients will be included in each therapy group. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Coxarthrosis | ||||
| Intervention ICMJE | Other: Conventional physiotherapy
Patients in this study group will attend physiotherapeutic exercise sessions of one hour three times a week for six weeks. The sessions consist of aerobic and muscle strengthening as well as coordination exercises. Patients will practice activities of daily living. The goals of these exercises are to improve joint stability, optimize knee and ankle proprioception, and advance neuromuscular innervation of the lower extremity and thereby suppress pathologic motion patterns. This should lead to optimized mobility, increased stability, and thus more endogenous analgesia of the affected joint |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | October 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01279174 | ||||
| Other Study ID Numbers ICMJE | Ortho-Koeln-1-2011, Version V1.55 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Peter Knöll, University Hospital of Cologne | ||||
| Study Sponsor ICMJE | University of Cologne | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Cologne | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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