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Completed

NCT Number: NCT06662682

Effects of Whole-Body Vibration in Patients With Knee Osteoarthritis.

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.

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Key information

Conditions

Knee Osteoarthristis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oniversity Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole-Body Vibration

Other

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

Control condition

Other

Non-intervention control condition

Primary outcomes

  1. 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

    Changes in pain of the osteo-arthrotic knee during the treadmill test as determined on a visual analogue scale (VAS 0-10).

Secondary outcomes

  1. 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.

    Changes in isometric maximum leg flexion strength of the osteoarthritis knee as determined by dynamometer (easy torque, Tonus, Germany)

  2. 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

    Changes in isometric maximum leg extension strength of the osteoarthritis knee as determined by dynamometer (easy torque, Tonus, Germany)

  3. 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

    Changes in number of repetitions in the 30 s sit-to-stand test as suggested by Guralnik et al.

  4. 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

    Changes of ipsilateral stride length (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)

  5. 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.

    Changes of ipsilateral stride length (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)

  6. 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.

    Changes of stride width (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)

  7. 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

    Changes of ipsilateral stance time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)

  8. 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

    Changes of ipsilateral single support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)

  9. 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

    Changes of double support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)

  10. 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

    Changes of trunk inclination (mm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)

  11. 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

    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)

  12. 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

    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)

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Acute Effects of Whole-Body Vibration on Pain, Neuromuscular Performance and Gait Quality in Patients With Knee Osteoarthritis. A Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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