NCT01037972

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

1.3 years

First QC Date

December 22, 2009

Last Update Submit

October 7, 2011

Conditions

Keywords

GalileoWhole body vibrationOsteoarthritisKneePhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Pain Reduction

    6 weeks after inclusion

Secondary Outcomes (8)

  • Motion analysis

    6 weeks after inclusion

  • Pain reduction

    12 weeks after inclusion

  • Pain reduction

    26 weeks after inclusion

  • Motion analysis

    12 weeks after inclusion

  • Motion analysis

    26 weeks after inclusion

  • +3 more secondary outcomes

Study Arms (2)

Whole body vibration

Behavioral: Whole body vibration

Conventional physiotherapy

Behavioral: Conventional physiotherapy

Interventions

3 times weekly 30 minutes of conventional physiotherapy to strengthen muscular strength and balance in the lower extremity.

Also known as: Galileo
Conventional physiotherapy

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.

Also known as: Galileo Whole body vibration
Whole body vibration

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with osteoarthritis of the knee.

You may qualify if:

  • years old
  • WOMAC 30-70 mm (VAS)
  • Gonarthrosis (Kellgren/Lawrence) II-III

You may not qualify if:

  • WOMAC \>70 mm (VAS)
  • Endoprosthesis in lower extremity
  • BMI \>40 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Cologne

Cologne, 50924, Germany

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kourosh Zarghooni, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR
  • Gregor Stein, MD

    University of Cologne

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Study Completion

October 1, 2011

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations