Clinical trial NCT06662682: Effects of Whole-Body Vibration in Patients with Knee Osteoarthritis.
Official title: Acute Effects of Whole-Body Vibration on Pain, Neuromuscular Performance and Gait Quality in Patients with Knee Osteoarthritis. a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthristis
Keywords: Knee OA
whole-body vibration
pain
physical function
gait parameters
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* x-ray confirmed knee osteoarthritis (Kallgren-Lawrence 2-3)
* knee pain (NRS 0-10 \&amp;gt;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.

Primary outcomes:
measure: Changes in pain of the osteo-arthrotic knee
timeFrame: 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
Secondary outcomes:
measure: Changes in isometric maximum leg flexion strength of the osteoarthritis knee
timeFrame: Changes in isometric maximum leg flexion strength of the osteoarthritis knee before and after 5 min of Intervention.
measure: Changes in isometric maximum leg extension strength of the osteoarthritis knee
timeFrame: Changes in isometric maximum leg extension strength of the osteoarthritis knee before and after 5 min of Intervention
measure: Changes of number of repetitions in the 30 s sit to stand (chair rise) test
timeFrame: Changes in number of repetitions in the 30 s sit-to-stand test before and after 5 min of intervention
measure: Changes of ipsilateral stride length
timeFrame: 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
measure: Changes of ipsilateral stride time
timeFrame: 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.
measure: Changes of stride width
timeFrame: 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.
measure: Changes of ipsilateral stance time
timeFrame: 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
measure: Changes of ipsilateral single support time
timeFrame: 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
measure: Changes of double support time
timeFrame: 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
measure: Changes of trunk inclination
timeFrame: 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
measure: Changes of ipsilateral und kontralateral knee angle in frontal plane
timeFrame: 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
measure: Changes of ipsilateral und kontralateral knee angle in sagital plane
timeFrame: 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
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Oniversity Hospital Erlangen
state: Bavaria
Study officials:
affiliation: University Hospital Erlangen, Germany
name: Marcel Betsch, MD
role: STUDY_DIRECTOR
References:
citation: von Stengel S, Kemmler W, Engelke K, Kalender WA. Effect of whole-body vibration on neuromuscular performance and body composition for females 65 years and older: a randomized-controlled trial. Scand J Med Sci Sports. 2012 Feb;22(1):119-27. doi: 10.1111/j.1600-0838.2010.01126.x. Epub 2010 May 24.