Osteoarthritis, KneeNCT06542692
Effect of Whole Body Vibration Therapy on Pain, Muscle Strength, Balance and Quality of Life in Knee Osteoarthritis
A study testing Whole Body Vibration and physical therapy modalities in people with Osteoarthritis, Knee and Osteoarthritis, run by Burak Çetinkaya at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of whole body vibration therapy on knee osteoarthritis. While the participants did static exercise in one group, whole body vibration therapy was applied during static exercise in another group. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis
- What is being tested?
- Whole Body Vibration and physical therapy modalities
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2023to 28 Dec 2023
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who were diagnosed with primary symptomatic knee OA according to ACR criteria,Ages between 35 and 70, Body mass index (BMI) ⩽35, Grade II or III according to Kellgren \& Lawrence scale, Patients with persistent symptoms such as pain and stiffness for at least 3 months were included.
Who cannot join
- Those who have had knee surgery before, Those with central nervous system disease (especially epilepsy and serious psychotic disorders), those with a history of acute arthritis, Those with a history of DVT in the last 24 weeks, Those with advanced lung or heart disease (COPD and heart failure), Those diagnosed with inflammatory rheumatic diseases (Rheumatoid arthritis, Spondyloarthropathy, etc.), Patients diagnosed with advanced stage cancer were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the effects of whole body vibration therapy on knee osteoarthritis. While the participants did static exercise in one group, whole body vibration therapy was applied during static exercise in another group. As a result of 15 sessions of treatment in both groups, the effects on pain, muscle strength, balance and quality of life were compared.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis
- Being tested
- Whole Body Vibration, physical therapy modalities
- Keywords
- vibration, whole body vibration, Osteoarthritis, Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationDevice
Also called physical therapy modalities
treatment duration, frequency
physical therapy modalitiesDevice
ultrasound, hot pack, tens
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Whole body vibration therapy added group Receives: Device: Whole Body Vibration; Device: physical therapy modalities |
| control group | Experimental | Not described Receives: Device: physical therapy modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scala
Scale ranging from 0 to 10 points, where 0 points indicate no pain and 10 points indicate maximum pain.
Measured: 3 weeks
Womac
Western Ontario and McMaster Universities Osteoarthritis Index
Measured: 3 weeks
muscle strength
isometric muscle strength measurement(knee extension, flexion)
Measured: 3 weeks
Biodex
Balance test
Measured: 3 weeks
Short Form 36
A test consisting of 36 questions to assess quality of life
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start28 Aug 2023
- Primary completion20 Oct 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burak Çetinkaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burak Çetinkaya, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542692
- Sponsor's protocol ID
- E68869993-511.06.01.01-1193507
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration Therapy on Pain, Muscle Strength, Balance and Quality of Life in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06542692
- Acronym / sponsor ID
- E68869993-511.06.01.01-1193507
- Conditions
- Osteoarthritis, Knee, Osteoarthritis
- Keywords
- vibration, whole body vibration, Osteoarthritis, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Burak ÇetinkayaUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 7 Aug 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.
The aim of this study is to examine the effects of whole body vibration therapy on knee osteoarthritis. While the participants did static exercise in one group, whole body vibration therapy was applied during static exercise in another group. As a result of 15 sessions of treatment in both groups, the effects on pain, muscle strength, balance and quality of life were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: Whole Body Vibration, Device: physical therapy modalitiesWhole body vibration therapy added group |
| control group | Experimental | Device: physical therapy modalities |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who were diagnosed with primary symptomatic knee OA according to ACR criteria,Ages between 35 and 70, Body mass index (BMI) ⩽35, Grade II or III according to Kellgren \& Lawrence scale, Patients with persistent symptoms such as pain and stiffness for at least 3 months were included.
Key exclusion criteria (1 listed)
- Those who have had knee surgery before, Those with central nervous system disease (especially epilepsy and serious psychotic disorders), those with a history of acute arthritis, Those with a history of DVT in the last 24 weeks, Those with advanced lung or heart disease (COPD and heart failure), Those diagnosed with inflammatory rheumatic diseases (Rheumatoid arthritis, Spondyloarthropathy, etc.), Patients diagnosed with advanced stage cancer were excluded from the study.
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 VibrationAlso: physical therapy modalitiestreatment duration, frequency | Device | study group |
| physical therapy modalitiesultrasound, hot pack, tens | Device | control group, study group |
Primary outcome
visual analog scala
Time frame: 3 weeks
Scale ranging from 0 to 10 points, where 0 points indicate no pain and 10 points indicate maximum pain.
Womac
Time frame: 3 weeks
Western Ontario and McMaster Universities Osteoarthritis Index
muscle strength
Time frame: 3 weeks
isometric muscle strength measurement(knee extension, flexion)
Biodex
Time frame: 3 weeks
Balance test
Short Form 36
Time frame: 3 weeks
A test consisting of 36 questions to assess quality of life
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 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and physical therapy modalities in people with Osteoarthritis, Knee and Osteoarthritis, run by Burak Çetinkaya at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 7 Aug 2024. 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 Turkey (Türkiye). 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?
visual analog scala (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.