Back to resultsGalileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis
Primary Purpose
Coxarthrosis
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Conventional physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Coxarthrosis focused on measuring Hip, arthrosis
Eligibility Criteria
Inclusion Criteria:
- Age 30 - 80 years
- Body weight less than or equal to 160 kg
- Body-Mass-Index less than 40 kg/m²
- Outpatient
- Legal competence
- Signed informed consent
- Uni- or bilateral Coxarthrosis according to ACR criteria
- WOMAC-pain index (visual analogue scale) of 30-70 mm
- Coxarthrosis stage II-III according to Kellgren and Lawrence
Exclusion Criteria:
- Participation in parallel interventional studies
- Bilateral Coxarthrosis with WOMAC Pain index more than 70 mm
- Previous surgery during the past 6 months at the Index Joint
- Injury of the study joint during the last 6 months
- Secondary rheumatoid or septic arthrosis or systemic diseases affecting the study joint
- Activated coxarthrosis with intraarticular effusion
- Body weight > 160 kg or body mass index > 40 kg/m²
- Analgesic therapy with steroidal drugs
- Physiotherapy of the lower extremities during the past 6 weeks
- Existing endoprosthetics in the lower extremities
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Conventional physiotherapy
Whole-body-vibration exercises
Arm Description
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
Patients in this study group will attend whole body vibration exercise sessions of one hour three times a week for six weeks, using the Galileo® Fitness device. Initial training sessions will focus on patient acclimatization, and afterwards improved on muscular capacity and body coordination. During exercise sessions, patients will do 6 training cycles of 3 minutes each. The goals of this treatment are improved proprioception of the ankle and knee joints, as well as optimization of neuronal reactivation of the muscles and thereby improved joint stability. This should also increase endogenous analgesia
Outcomes
Primary Outcome Measures
Changes in Womac
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
Secondary Outcome Measures
SF-12
The SF-12 score uses subjective patient responses to measure success of therapy and thereby evaluate quality of life. SF-12 is the abbreviated version of the SF-36 Health Survey and contains 12 items representing 8 dimensions of physical and mental fitness. In our study, the validated German translation will be used
Leonardo Mechanography
Functional motion analysis, the Modified Clinical Test of Sensory Interaction in Balance, the Tandem Walk Test, and the Rhythmic Weight Shift Test will be performed using the Leonardo Mechanography Gangway (Novotec Inc., Pforzheim, Germany) and the Balance Master Analysis System (Neurocom Inc., Clackamas, USA). These will provide reliable data on essential parts of ambulation, e.g. stride length, speed of movement, shifting of balance point, force, power, and workload
Full Information
NCT ID
NCT01279174
First Posted
January 18, 2011
Last Updated
December 8, 2015
Sponsor
University of Cologne
1. Study Identification
Unique Protocol Identification Number
NCT01279174
Brief Title
Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis
Official Title
Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Coxarthrosis: a Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis
Keywords
Hip, arthrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional physiotherapy
Arm Type
Other
Arm Description
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
Arm Title
Whole-body-vibration exercises
Arm Type
Experimental
Arm Description
Patients in this study group will attend whole body vibration exercise sessions of one hour three times a week for six weeks, using the Galileo® Fitness device. Initial training sessions will focus on patient acclimatization, and afterwards improved on muscular capacity and body coordination. During exercise sessions, patients will do 6 training cycles of 3 minutes each. The goals of this treatment are improved proprioception of the ankle and knee joints, as well as optimization of neuronal reactivation of the muscles and thereby improved joint stability. This should also increase endogenous analgesia
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Womac
Description
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
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
SF-12
Description
The SF-12 score uses subjective patient responses to measure success of therapy and thereby evaluate quality of life. SF-12 is the abbreviated version of the SF-36 Health Survey and contains 12 items representing 8 dimensions of physical and mental fitness. In our study, the validated German translation will be used
Time Frame
26 weeks
Title
Leonardo Mechanography
Description
Functional motion analysis, the Modified Clinical Test of Sensory Interaction in Balance, the Tandem Walk Test, and the Rhythmic Weight Shift Test will be performed using the Leonardo Mechanography Gangway (Novotec Inc., Pforzheim, Germany) and the Balance Master Analysis System (Neurocom Inc., Clackamas, USA). These will provide reliable data on essential parts of ambulation, e.g. stride length, speed of movement, shifting of balance point, force, power, and workload
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 30 - 80 years
Body weight less than or equal to 160 kg
Body-Mass-Index less than 40 kg/m²
Outpatient
Legal competence
Signed informed consent
Uni- or bilateral Coxarthrosis according to ACR criteria
WOMAC-pain index (visual analogue scale) of 30-70 mm
Coxarthrosis stage II-III according to Kellgren and Lawrence
Exclusion Criteria:
Participation in parallel interventional studies
Bilateral Coxarthrosis with WOMAC Pain index more than 70 mm
Previous surgery during the past 6 months at the Index Joint
Injury of the study joint during the last 6 months
Secondary rheumatoid or septic arthrosis or systemic diseases affecting the study joint
Activated coxarthrosis with intraarticular effusion
Body weight > 160 kg or body mass index > 40 kg/m²
Analgesic therapy with steroidal drugs
Physiotherapy of the lower extremities during the past 6 weeks
Existing endoprosthetics in the lower extremities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Knöll
Organizational Affiliation
University Hospital of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Cologne
ZIP/Postal Code
50924
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis
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