- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06662682
Effects of Whole-Body Vibration in Patients with Knee Osteoarthritis.
Acute Effects of Whole-Body Vibration on Pain, Neuromuscular Performance and Gait Quality in Patients with Knee Osteoarthritis. a Randomized Controlled Trial.
Knee osteoarthritis is a chronic joint disease with an impact on quality of life and an increasing incidence what leads to huge costs and burden on the economy.
The present study investigates immediate effects of whole-body vibration on pain, neuromuscular performance, and gait quality in patients with knee osteoarthritis. Eligible patients (n=20) with knee osteoarthritis grade 2 or 3 on Kallgren Lawrence will complete a 5 minute WBV training and a control condition in a randomized order (cross over design). Pain, maximum strength of the leg flexors and extensors, the chair rise test and gait parameters will be measured directly before and after the intervention/control.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bavaria
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Erlangen, Bavaria, Germany, 91054
- Oniversity Hospital Erlangen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- x-ray confirmed knee osteoarthritis (Kallgren-Lawrence 2-3)
- knee pain (NRS 0-10 >2) for 3 months and at least 50% of the last 30 days
Exclusion Criteria:
- contraindications for WBV (acute injuries of the musculoskeletal system, new joint endoprosthesis, pregnancy, acute thrombosis, Epilepsia, cholecystolithiasis, nephrolithiasis, heart pace maker),
- other pathologies affecting gait or neuromuscular performance (rheumatic
- opioid medications, cortisol medications and intraarticular injections in the knee during the ist 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Whole-Body Vibration
The intervention (IC) will be specified as a five-minute Whole-Body Vibration session.
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The intervention (IC) will be specified as a five-minute Whole-Body Vibration session.
The WBV take place on a side alternating vibration plate (Wellengang, Germany).
The patients stand barefoot on the vibration plate on a prescribed position.
In this position the amplitude will be 6-7mm.
The WBV protocol contains mobilizing sequences with lower frequencies and activating sequences with higher frequencies
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Other: Control Condition
The control condition (CC) will conduct the same protocol as the intervention condition.
The only difference will be that the vibration plate will be switched off.
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Non-intervention control condition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in pain of the osteo-arthrotic knee
Time Frame: Changes in pain of the osteoarthrotic knee during the treadmill test as determined on a visual analogue scale (VAS 0-10) before and after 5 min of intervention
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Changes in pain of the osteo-arthrotic knee during the treadmill test as determined on a visual analogue scale (VAS 0-10).
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Changes in pain of the osteoarthrotic knee during the treadmill test as determined on a visual analogue scale (VAS 0-10) before and after 5 min of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in isometric maximum leg flexion strength of the osteoarthritis knee
Time Frame: Changes in isometric maximum leg flexion strength of the osteoarthritis knee before and after 5 min of Intervention.
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Changes in isometric maximum leg flexion strength of the osteoarthritis knee as determined by dynamometer (easy torque, Tonus, Germany)
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Changes in isometric maximum leg flexion strength of the osteoarthritis knee before and after 5 min of Intervention.
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Changes in isometric maximum leg extension strength of the osteoarthritis knee
Time Frame: Changes in isometric maximum leg extension strength of the osteoarthritis knee before and after 5 min of Intervention
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Changes in isometric maximum leg extension strength of the osteoarthritis knee as determined by dynamometer (easy torque, Tonus, Germany)
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Changes in isometric maximum leg extension strength of the osteoarthritis knee before and after 5 min of Intervention
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Changes of number of repetitions in the 30 s sit to stand (chair rise) test
Time Frame: Changes in number of repetitions in the 30 s sit-to-stand test before and after 5 min of intervention
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Changes in number of repetitions in the 30 s sit-to-stand test as suggested by Guralnik et al.
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Changes in number of repetitions in the 30 s sit-to-stand test before and after 5 min of intervention
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Changes of ipsilateral stride length
Time Frame: Changes of ipsilateral stride length (cm) at treadmill as determined by the 4D motion high-performance lab ( (Firma Diers Formetric, Germany) before and after 5 min of Intervention
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Changes of ipsilateral stride length (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
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Changes of ipsilateral stride length (cm) at treadmill as determined by the 4D motion high-performance lab ( (Firma Diers Formetric, Germany) before and after 5 min of Intervention
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Changes of ipsilateral stride time
Time Frame: Changes of ipsilateral stride length (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention.
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Changes of ipsilateral stride length (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
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Changes of ipsilateral stride length (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention.
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Changes of stride width
Time Frame: Changes of stride width (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention.
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Changes of stride width (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
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Changes of stride width (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention.
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Changes of ipsilateral stance time
Time Frame: Changes of ipsilateral stance time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of ipsilateral stance time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
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Changes of ipsilateral stance time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of ipsilateral single support time
Time Frame: Changes of ipsilateral single support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of ipsilateral single support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
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Changes of ipsilateral single support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of double support time
Time Frame: Changes of double support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of double support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
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Changes of double support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of trunk inclination
Time Frame: Changes of trunk inclination (mm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of trunk inclination (mm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
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Changes of trunk inclination (mm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of ipsilateral und kontralateral knee angle in frontal plane
Time Frame: Changes of ipsilateral und kontralateral knee angle (°) in frontal plane at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of ipsilateral und kontralateral knee angle (°) in frontal plane at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
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Changes of ipsilateral und kontralateral knee angle (°) in frontal plane at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of ipsilateral und kontralateral knee angle in sagital plane
Time Frame: Changes of ipsilateral und kontralateral knee angle in sagital plane (°) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Changes of ipsilateral und kontralateral knee angle in sagital plane (°) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
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Changes of ipsilateral und kontralateral knee angle in sagital plane (°) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany) before and after 5 min of intervention
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Collaborators and Investigators
Investigators
- Study Director: Marcel Betsch, MD, University Hospital Erlangen, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RadioSurg1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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