Knee OsteoarthristisNCT06662682
Effects of Whole-Body Vibration in Patients With Knee Osteoarthritis.
A study testing Whole-Body Vibration in people with Knee Osteoarthristis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Whole-Body Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2024to 16 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Knee Osteoarthristis
- Being tested
- Whole-Body Vibration, Control Condition
- Keywords
- Knee OA, whole-body vibration, pain, physical function, gait parameters
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body VibrationOther
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 ConditionOther
Non-intervention control condition
| Study group | Role | What they receive |
|---|---|---|
| Whole-Body Vibration | Experimental | The intervention (IC) will be specified as a five-minute Whole-Body Vibration session. Receives: 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. Receives: Other: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 as determined by dynamometer (easy torque, Tonus, Germany)
Measured: 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 as determined by dynamometer (easy torque, Tonus, Germany)
Measured: 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 as suggested by Guralnik et al.
Measured: 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)
Measured: 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)
Measured: 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 stride width
Changes of stride width (cm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
Measured: 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 ipsilateral stance time
Changes of ipsilateral stance time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
Measured: 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 single support time
Changes of ipsilateral single support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
Measured: 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 double support time
Changes of double support time (%) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
Measured: 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 trunk inclination
Changes of trunk inclination (mm) at treadmill as determined by the 4D motion high-performance lab (Firma Diers Formetric, Germany)
Measured: 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 ipsilateral und kontralateral knee angle in frontal plane
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)
Measured: 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 sagital plane
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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start15 Jul 2024
- Primary completion15 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Kemmler, PhD, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Investigators
- Marcel Betsch, MD, Study director, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662682
- Sponsor's protocol ID
- RadioSurg1
- Status last verified
- Jan 2025
- First submitted
- 18 Oct 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20500555
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Whole-Body Vibration on Pain, Neuromuscular Performance and Gait Quality in Patients With Knee Osteoarthritis. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06662682
- Acronym / sponsor ID
- RadioSurg1
- Conditions
- Knee Osteoarthristis
- Keywords
- Knee OA, whole-body vibration, pain, physical function, gait parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-Body Vibration | Experimental | Other: Whole-Body VibrationThe intervention (IC) will be specified as a five-minute Whole-Body Vibration session. |
| Control Condition | Other | Other: Control ConditionThe 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Body VibrationThe 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 | Other | Whole-Body Vibration |
| Control ConditionNon-intervention control condition | Other | Control Condition |
Primary outcome
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).
12 secondary outcomes
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 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 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 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 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 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 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 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 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 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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Results publication: PubMed 20500555von 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Betsch, MD study director
University Hospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Vibration in people with Knee Osteoarthristis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.