Protocol summary

Summary
The aim of this study was to evaluate the effect of kinesiotape on pain and range of motion and knee proprioception in patients with osteoarthritis of the knee. People with knee arthritis diagnosed according to America College of Rheumatology criteria and radiography kellgrance with grades 1-2-3. Before applying the type of pain based on pain questionnaire and active range of motion is measured by a goniometer. Knee deep sense based on the ability to proactively position is measured at three different angles.One group is applied by kinesiotape and the other by sham tape. An hour after this amount of pain, active range of motion and proprioception is gonna be checked to see the effect.Functional testing "6MWT" , "Timed Up and Go Test" will also be checked. 72h after taping patients will come again and pain and range of motion and properioception and the functional tests will be checked again and tape is removed.After 2 weeks the peaple in groups are crossed and the procedure is repeated again in all stages for tow groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020527264N2
Registration date: 2017-04-02, 1396/01/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-02, 1396/01/13
Registrant information
Name
Maryam Abolhasani
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8569
Email address
m_abolhasani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Imam khomeini Hospital
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of kinesitaping on pain, range of motion and proprioception in patients with osteoarthritis of the knee (a crossover study)
Public title
Kinesiotape Effect on pain and range of motion in knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included those over 45 years with osteoarthritis of the knee based on diagnostic criteria (American College of Rheumatology knee pain plus at least three of characteristics: age greater than 50 years, morning stiffness less than 30 minutes, , bone tenderness , bony enlargement, warm untouchable or osteophytes in knee pain plus radiography as well as at least one of the following characteristics: age greater than 50 years, morning stiffness less than 30 minutes, ) grade 2 or 3 (system based on Kellgren and Lawrence). patients should not have had articular corticosteroid injection in 3 months, and PRP gel in a recent year. and also do not have previous treatment with Kinesiotape.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2016-08-04, 1395/05/14
Ethics committee reference number
94112255001 شماره نامه:IR.TUMS.IKHC.REC.1395.380

Health conditions studied

1

Description of health condition studied
knee osteoarthtiris
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral

Primary outcomes

1

Description
Pain
Timepoint
before and after taping the knee
Method of measurement
VAS questionnare

2

Description
Disease duration
Timepoint
before taping the knee
Method of measurement
questionnare

3

Description
Range of motion of knee
Timepoint
before and after taping the knee
Method of measurement
goniometer

Secondary outcomes

1

Description
Up anf Go test
Timepoint
after taping
Method of measurement
Time to stand up from the chair and walked three meters and sit in this chair

2

Description
6MWT
Timepoint
after taping
Method of measurement
distance in 6minutes gone

Intervention groups

1

Description
Intervention group: Before applying the kinesiotape pain is assessed on the basis of a VAS questionnaire and active range of motion is measured by a goniometer. Knee proprioception is measured at three different angles.Kinesiotape is applied and 1 hour after that pain on the basis of VAS and deep knee sensation by goniometer is measured.Functional tests”6MWT-Up and Go Test” is gonna be assessed. 72 hours later, patients are referred to the removal of tape prior to it are being re-assessment of pain, range of motion and proprioception and the functional tests.2weeks after,the groups are gonna be crossed.
Category
Rehabilitation

2

Description
Control group: Sham tape is appleid.Before applying the sham-tape pain is assessed on the basis of a VAS questionnaire and active range of motion is measured by a goniometer. Knee proprioception is measured at three different angles.Sham tape is applied and 1 hour after that pain on the basis of VAS and deep knee sensation by goniometer is measured.Functional tests”6MWT-Up and Go Test” is gonna be assessed. 72 hours later, patients are referred to the removal of tape prior to it are being re-assessment of pain, range of motion and proprioception and the functional tests.2weeks after,the groups are gonna be crossed.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Azadeh Hakakzade
Street address
Keshavar Blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice Chancellor of "Tehran University Of Medical Sciences"
Full name of responsible person
Masood Yoonesian
Street address
" Tehran University Of Medical Sciences"
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor of "Tehran 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
Imam khomeini hospital ,Sports medicine ward
Full name of responsible person
Azadeh Hakakzadeh
Position
Sports medicine Resident
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
ahakakzade@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University Medical Sciences
Full name of responsible person
Maryam Abolhasani
Position
Sport Medicine Specialist
Other areas of specialty/work
Street address
Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
dr_m_abolhasani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Imam khomeini Hospital
Full name of responsible person
Azadeh Hakakzadeh
Position
Sports Medicine Residnt
Other areas of specialty/work
Street address
Keshavarz blvd.
City
Tehran
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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