The effect of dynamic tape and kinesio tape on pain and electromyographic activity of selected thigh muscles in women with patellofemoral pain syndrome
This study aims to determine the effect of kinesio tape and dynamic tape on pain and electromyographic activity of selected thigh muscles in 20-30-year-old women with patellofemoral syndrome.
Design
A randomized, single-blind, cross-over, phase 2 study of 40 women with patellofemoral pain. A lottery will be done for randomization.
Settings and conduct
This study will be performed in the sports rehabilitation laboratory of Bu Ali Sina University. Each participant is evaluated in three different sessions with kinesio tape, dynamic tape, and control. The data analyzer will be blinded to the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patellofemoral pain syndrome; Pain higher than 3 according to the visual analog scale; Age between 20 and 30 years.
Exclusion criteria: showing skin irritation sens to tape; Having a history of lower limb surgery.
Intervention groups
Intervention 1: Kinesiotype. In this condition, kinesio tape is applied to the knee. Then the evaluations are done.
Intervention group 2: Dynamic type: In this condition the dynamic tape is applied to the knee. Then the evaluations are done.
Control group: In the control condition without tape, evaluations are done.
Main outcome variables
Pain; Electromyographic activity of muscles; Joint position sense; Balance; Postural control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046368N10
Registration date:2023-06-03, 1402/03/13
Registration timing:prospective
Last update:2023-06-03, 1402/03/13
Update count:0
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Zahra Raeisi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3492
Email address
z_raisi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-15, 1402/03/25
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dynamic tape and kinesio tape on pain and electromyographic activity of selected thigh muscles in women with patellofemoral pain syndrome
Public title
The effect of dynamic type and kinesio tape on people with patellofemoral pain syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A history of pain behind or around the one-sided patella caused by at least two of the following activities: long-term sitting, climbing stairs, squatting, running, kneeling, and jumping
positive patellar grind test
Pain level of at least 30 mm on a 100 mm visual analog scale
Exclusion criteria:
History of knee surgery
Skin irritation to the tape
Age
From 20 years old to 30 years old
Gender
Female
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 3 interventions of kinesio tape, dynamic tape, and control are investigated and compared in a group of women with patellofemoral pain syndrome. Each intervention is done in a separate session. The order of interventions for each participant will be chosen randomly and by lottery at the beginning of each session.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not be aware of the group's classification. The information of the groups will be provided to the data analyzer in the form of numbers 1, 2, and 3, and for each participant with a code.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bu Ali Sina university ethics committee in research
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.BASU.REC.1402.013
Health conditions studied
1
Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Pain
Timepoint
Before and after tape
Method of measurement
Visual analogue scale
2
Description
Electromyographic activity of muscles
Timepoint
Before and after tape
Method of measurement
Electromyography
Secondary outcomes
1
Description
Joint position sense
Timepoint
Before and after taping
Method of measurement
Photogrammetry
2
Description
Dynamic balance
Timepoint
Before and after taping
Method of measurement
Y balance test
3
Description
Postural control
Timepoint
Before and after taping
Method of measurement
Foot pressure
Intervention groups
1
Description
Intervention group 1: Kinesio tape. In this condition, kinesio tape is applied to the knee. Then the evaluations are done.
Category
Other
2
Description
Intervention group 2: Dynamic tape: In this condition the dynamic tape is applied to the knee. Then the evaluations are done.
Category
Other
3
Description
Control group: Control group: evaluations are done in control conditions (without tape).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-ali Sina university
Full name of responsible person
Ali Yalfani
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517833131
Phone
+98 81 3838 1422
Email
Ali_yalfani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Arash Ghorbani
Street address
Bu Ali Sina University, Chahar Bagh Martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517833131
Phone
+98 81 3838 1601
Email
sakhai@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali-Sina University
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
Bu Ali-Sina University
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1422
Email
ali_yalfani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1422
Email
ali_yalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1422
Email
ali_yalfani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available