Regarding several useful effects of vibration on the muscle performance improvement, this study has been designed to investigate the local vibration effect on the knee osteoarthritis (KO) complications. 60 Patient with mild or moderate osteoarthritis were allocated into two groups (30 in each group) to receive either 1 minute 50 Hz Vibration on the quadriceps plus conventional physiotherapy protocol including Hot Pack, TENS and necessary instructions or only conventional physiotherapy protocol (as above). The interventions will be applied in 15 therapeutic sessions (5 days in week). Main outcome measures are: increase in Isokinetic muscle concentric contraction torque of both quadriceps, decrease in pain perception measured through VAS, increase in pressure pain threshold, increase in standing static and dynamic equilibrium, increase in passive and active knee range of motion without pain, decrease in knee joint effusion, decrease in knee Joint morning stiffness, increase in walking Speed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803061254N2
Registration date:2009-07-21, 1388/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-07-21, 1388/04/30
Registrant information
Name
Amir Hoshang Bakhtiary Davijani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 1983
Email address
amirbakhtiary@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2010-01-20, 1388/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of the local vibration effect on the knee Osteoarthritis complications
Public title
The investigation of the local vibration effect on the knee Osteoarthritis complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: mild to moderate unilateral or bilateral chronic tibiofemoral osteoarthritis, ability to walk with or without stick
Exclusion criteria: other conditions such as Diabetic, Musculoskeletal, neuromuscular, pulmonary disorders, Joint injection or other invasive interventions on knee during 3 months prior to study, hip or knee arthroplasty, consumption of any medicine, trauma to knee in last week, severe weakness
Age
From 35 years old to 76 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comitte of Semnan University of Medical Science
Street address
Blv. Bassij, Education Affaire Building
City
Semnan
Postal code
Approval date
2009-05-26, 1388/03/05
Ethics committee reference number
2409
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
Isokinetic muscle torque of Quadriceps and Hamstrings muscles during concentric contraction (Extension/Flexion) at angular velocity of 30°, 60° and 90° per second in each right and left leg
Timepoint
Before and After 15 Session theraputic intervention and 4 week after the last intervention
Method of measurement
Using Muscles Torque meter
Secondary outcomes
1
Description
1)Dynamic and static balance indices in anterior-posterior, Medial-lateral directions and overall balance index 2) Western Ontario and McMaster universities osteoarthritis index
Timepoint
Before and After 15 Session theraputic intervention and 4 week after the last intervention
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Physiotherapy including Hot pack, conventional TENS and recomended instruction 5 days a week for 15 sessions
Category
Other
2
Description
Physiotherapy including Hot pack, conventional TENS and recomended instruction 5 days a week for 15 sessions in addition to Local 50 Hz Vibration for 1 minute on the quadriceps 5 days in a week for 15 session
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Street address
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Faranoush
Street address
Educational and Research Affair, Semnan University of Medical Sciences, Basij Blvd.
City
Seman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Amir Hoshang Bakhtiary
Position
Associate professor/ PhD
Other areas of specialty/work
Street address
Rehabilitation Faculty, km 5 road to Damghan
City
Seman
Postal code
Phone
+98 23 1444 1983
Fax
Email
amirbakhtiary@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Amir Hoshang Bakhtiary
Position
Associate Professor/ PhD
Other areas of specialty/work
Street address
Rehabilitation Faculty, Km 5 Road to Damghan
City
Semnan
Postal code
Phone
+98 23 1444 1983
Fax
Email
amirbakhtiary@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Amir Hoshang Bakhtiary
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)