OsteoarthritisNCT01037972
Influence of Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Gonarthrosis
An observational study of Osteoarthritis, run by University of Cologne at 1 site in Germany.
Trial summary
40 patients with osteoarthritis of the knee will be randomly assigned to conventional physiotherapy on the one and whole body vibration exercises on the other hand. The duration of the training will be 6 weeks, three times a week. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Conventional physiotherapy and Whole body vibration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Oct 2011
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with osteoarthritis of the knee.
Who may be able to join
- 30-80 years old
- WOMAC 30-70 mm (VAS)
- Gonarthrosis (Kellgren/Lawrence) II-III
Who cannot join
- WOMAC >70 mm (VAS)
- Endoprosthesis in lower extremity
- BMI >40 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
40 patients with osteoarthritis of the knee will be randomly assigned to conventional physiotherapy on the one and whole body vibration exercises on the other hand. The duration of the training will be 6 weeks, three times a week.
The outcome will be measured by WOMAC and SF-12 scores relating to pain and quality of life. The second outcome criteria will be a motion analysis and balance testing before and after the training.
The follow-up is 26 weeks.
- Conditions
- Osteoarthritis
- Being tested
- Conventional physiotherapy, Whole body vibration
- Keywords
- Galileo, Whole body vibration, Osteoarthritis, Knee, Physiotherapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyBehavioural
Also called Galileo
3 times weekly 30 minutes of conventional physiotherapy to strengthen muscular strength and balance in the lower extremity.
Whole body vibrationBehavioural
Also called Galileo Whole body vibration
3 times weekly 30 minutes of exercises on a whole body vibration device to strengthen muscular strength and improve muscular balance in the lower extremity.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration | Not described Receives: Behavioral: Whole body vibration | |
| Conventional physiotherapy | Not described Receives: Behavioral: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Measured: 6 weeks after inclusion
Secondary outcomes (8)
Motion analysis
Measured: 6 weeks after inclusion
Pain reduction
Measured: 12 weeks after inclusion
Pain reduction
Measured: 26 weeks after inclusion
Motion analysis
Measured: 12 weeks after inclusion
Motion analysis
Measured: 26 weeks after inclusion
Quality of life
Measured: 6 weeks after inclusion
Quality of life
Measured: 12 weeks after inclusion
Quality of life
Measured: 26 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionOct 2011
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 OsteoarthritisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gregor Stein, University of Cologne
- Investigators
- Kourosh Zarghooni, MD, Principal investigator, University of CologneGregor Stein, MD, Study director, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037972
- Sponsor's protocol ID
- Galileo
- Other IDs
- 2009-017617-29, 2009
- Status last verified
- Oct 2011
- First submitted
- 22 Dec 2009
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein G, Knoell P, Faymonville C, Kaulhausen T, Siewe J, Otto C, Eysel P, Zarghooni K. Whole body vibration compared to conventional physiotherapy in patients with gonarthrosis: a protocol for a randomized, controlled study. BMC Musculoskelet Disord. 2010 Jun 21;11:128. doi: 10.1186/1471-2474-11-128.
PubMed 20565956
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Gonarthrosis
- ClinicalTrials.gov ID
- NCT01037972
- Acronym / sponsor ID
- Galileo
- Conditions
- Osteoarthritis
- Keywords
- Galileo, Whole body vibration, Osteoarthritis, Knee, Physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Dec 2009 (estimated)
- 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.
40 patients with osteoarthritis of the knee will be randomly assigned to conventional physiotherapy on the one and whole body vibration exercises on the other hand. The duration of the training will be 6 weeks, three times a week.
The outcome will be measured by WOMAC and SF-12 scores relating to pain and quality of life. The second outcome criteria will be a motion analysis and balance testing before and after the training.
The follow-up is 26 weeks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration | – | Behavioral: Whole body vibration |
| Conventional physiotherapy | – | Behavioral: Conventional physiotherapy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoarthritis of the knee.
Key inclusion criteria (3 listed)
- 30-80 years old
- WOMAC 30-70 mm (VAS)
- Gonarthrosis (Kellgren/Lawrence) II-III
Key exclusion criteria (3 listed)
- WOMAC >70 mm (VAS)
- Endoprosthesis in lower extremity
- BMI >40 kg/m2
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 |
|---|---|---|
| Conventional physiotherapyAlso: Galileo3 times weekly 30 minutes of conventional physiotherapy to strengthen muscular strength and balance in the lower extremity. | Behavioural | Conventional physiotherapy |
| Whole body vibrationAlso: Galileo Whole body vibration3 times weekly 30 minutes of exercises on a whole body vibration device to strengthen muscular strength and improve muscular balance in the lower extremity. | Behavioural | Whole body vibration |
Primary outcome
Pain Reduction
Time frame: 6 weeks after inclusion
8 secondary outcomes
Motion analysis
Time frame: 6 weeks after inclusion
Pain reduction
Time frame: 12 weeks after inclusion
Pain reduction
Time frame: 26 weeks after inclusion
Motion analysis
Time frame: 12 weeks after inclusion
Motion analysis
Time frame: 26 weeks after inclusion
Quality of life
Time frame: 6 weeks after inclusion
Quality of life
Time frame: 12 weeks after inclusion
Quality of life
Time frame: 26 weeks after inclusion
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 12 Oct 2011.
- Derived from this study: PubMed 20565956Stein G, Knoell P, Faymonville C, Kaulhausen T, Siewe J, Otto C, Eysel P, Zarghooni K. Whole body vibration compared to conventional physiotherapy in patients with gonarthrosis: a protocol for a randomized, controlled study. BMC Musculoskelet Disord. 2010 Jun 21;11:128. doi: 10.1186/1471-2474-11-128.
- University Hospital of CologneLink provided by the sponsor.
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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.
Kourosh Zarghooni, MD principal investigator
University of Cologne
Gregor Stein, MD study director
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by University of Cologne 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 3 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 12 Oct 2011. 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?
Pain Reduction (time frame: 6 weeks after inclusion). 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 NCT01037972, 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 12 Oct 2011.