Determination of the effects of kinesiotaping of vastus medialis obliqus muscle on pain and balance in the elderly with knee osteoarthritis
Design
Parallel group randomized clinical trial , double blind
Settings and conduct
Samples will be entered into the study after being informed about participation in the research and to complete the informed consent form. Then, they will be randomly divided into two groups of real and placebo kinesiotapes. They will not be known about type of received kinesiotape. Also, tapes will be installed by a therapist and evaluations will be done by another therapist. The assessor will not be aware of the type of treatment they receive.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 65 years; involvement to moderate knee osteoarthritis based on Kellgren and Lawrenc criteria; gain score less than 35 from Fullerton Advanced Balance Scale and less than 7 from Geriatric Depression Scale. Gain at least 24 scores from the Mini Mental Status Examination questionnaire and 3-6 from pain Visual Analogue Scale.
Exclusion criteria: Neurological diseases (parkinson, stroke, neuropathy); joint replacement; vision and hearing impairment; ortho-static hypotension, dizziness and history of fall in the last 6 months; history of dislocation and fracture of the lower limb joints; history of knee, spine and ankle surgeries; history of menisci, quadriceps tendon and ligaments injuries of knee joint; allergy to kinsiotape
Intervention groups
In the intervention group, The 5-cm kinesiotape is applied to the skin along the vastus medialis obliqus muscle from the beginning to the end of the muscle ( 75% maximum tension). in the control group, the kinesiotape without tension is applied to the skin along the tibial crest.In the both groups intervention will take place in three sessions, with a two-day interval.
Main outcome variables
Knee pain; balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090115001552N7
Registration date:2018-06-22, 1397/04/01
Registration timing:prospective
Last update:2018-06-22, 1397/04/01
Update count:0
Registration date
2018-06-22, 1397/04/01
Registrant information
Name
Maryam Ebrahimian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
ebrahimian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-05, 1397/04/14
Expected recruitment end date
2018-11-05, 1397/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of kinesiotaping of vastus medialis obliqus muscle on pain and balance in the elderly with knee osteoarthritis
Public title
The effect of taping on pain and balance in the elderly with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 65 years old
Moderate knee osteoarthritis based on Kellgren and Lawrenc criteria approved by orthopedic surgeon or physiatrist
Gain score less than 35 from Fullerton Advanced Balance (FAB) Scale
Gain score less than 7 from Geriatric Depression Scale (GDS)
Gain at least 24 scores from the Mini Mental Status Examination (MMSE) questionnaire
Gain score 3-6 from pain Visual Analogue Scale (VAS)
Exclusion criteria:
Neurological diseases (Parkinson's disease, stroke, neuropathy, etc.) and certain orthopedic diseases such as joint replacement
Having vision and hearing impairment, color blindness and ortho-static hypotension
Dizziness and having a history of fall in the last 6 months
History of dislocation and fracture of the lower limb joints and patella
History of knee, spine and ankle surgeries
History of menisci, quadriceps tendon and ligaments injuries of knee joint
History of allergy to kinsiotape
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done based on the permutation block using the Randomizer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Samples will be entered into the study after being informed about the conditions for participation in the research, how to carry out evaluations and interventions, and to complete the informed consent form. Then, they will be randomly divided into two groups of real and placebo Kinesiotapes. They will not be known about type of received Kinesiotape. Also, tapes will be installed by a therapist and evaluations will be done by another therapist and the evaluator will not be aware of the type of treatment they receive.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Oppsite to Felestin Street, Zand Avenue
City
Shiraz
Province
Fars
Postal code
1433671348
Approval date
2018-05-08, 1397/02/18
Ethics committee reference number
IR.SUMS.REC.1397.143
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M15.4
ICD-10 code description
Erosive (osteo) arthrosis
Primary outcomes
1
Description
knee pain
Timepoint
The first session and one day after the last session of the intervention
Method of measurement
Pain Visual Analogue Scale
2
Description
Balance
Timepoint
The first session and one day after the last session of the intervention
Method of measurement
Fullerton Advanced Balance Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The 5-cm kinesiotape is applied to the skin along the vastus medialis obliqus muscle from the beginning to the end of the muscle (with 75% maximum tension). The intervention will take place in three sessions, with a two-day interval.
Category
Rehabilitation
2
Description
Control group: The 5-cm kinesiotape without tension is applied to the skin along the tibial crest. The intervention will take place in three sessions, with a two-day interval.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Jahandidegan Center
Full name of responsible person
Roya Razavi
Street address
Kholdebarin Park, Shahid Beheshti Blvd.
City
Shiraz
Province
Fars
Postal code
7183654876
Phone
+98 71 3647 5010
Fax
+98 71 3647 5010
Email
Razavi.roya@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
7th fioor of Central Building of Shiraz University of Medi cal Sciences,In front of Felestin Street, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Abiverdi Ave., Shahid Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
ebrahimian@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Moslemi Haghighi
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Abiverdi Ave., Shahid Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
moslemif@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Abiverdi Ave., Shahid Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
ebrahimian@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data are shareable after samples unidentification
When the data will become available and for how long