NCT06662682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

October 18, 2024

Last Update Submit

January 29, 2025

Conditions

Keywords

Knee OAwhole-body vibrationpainphysical functiongait parameters

Outcome Measures

Primary Outcomes (1)

  • Changes in pain of the osteo-arthrotic knee

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

    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 (12)

  • Changes in isometric maximum leg flexion strength of the osteoarthritis knee

    Changes in isometric maximum leg flexion strength of the osteoarthritis knee before and after 5 min of Intervention.

  • Changes in isometric maximum leg extension strength of the osteoarthritis knee

    Changes in isometric maximum leg extension strength of the osteoarthritis knee before and after 5 min of Intervention

  • Changes of number of repetitions in the 30 s sit to stand (chair rise) test

    Changes in number of repetitions in the 30 s sit-to-stand test before and after 5 min of intervention

  • Changes of ipsilateral stride length

    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 time

    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.

  • +7 more secondary outcomes

Study Arms (2)

Whole-Body Vibration

EXPERIMENTAL

The intervention (IC) will be specified as a five-minute Whole-Body Vibration session.

Other: Whole-Body Vibration

Control Condition

OTHER

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.

Other: Control Condition

Interventions

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

Whole-Body Vibration

Non-intervention control condition

Control Condition

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oniversity Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (1)

  • 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.

    PMID: 20500555BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marcel Betsch, MD

    University Hospital Erlangen, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor were unaware of participants status and were not allowed to ask correpondingly
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 29, 2024

Study Start

July 15, 2024

Primary Completion

January 15, 2025

Study Completion

January 16, 2025

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations