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Comparison of effects of Kinesio taping versus McConnell taping on function and dynamic postural control in athletes with patellofemoral pain syndrome

Protocol summary

Study aim
To compare the effects of Kinesio taping versus McConnell taping on function and dynamic postural control in athletes with patellofemoral pain syndrome.
Design
Parallel groups, single blinded, single setting randomized control trial
Settings and conduct
Spine Physiotherapy Clinic, Sahiwal.
Participants/Inclusion and exclusion criteria
Inclusion Criteria • Referred athletes with chronic PFPS, Patients diagnosed with chronic PFPS, Subject not received taping before, Subject not receiving any pain killer or medical treatment, Positive Clark’s test , Age: 18 to 40 years, Both gender Exclusion Criteria Patients with history of: Ankle and hip pathology, Any other knee abnormality or arthritis, Lower limb fracture, Subject using corticosteroids, Pregnancy, Irritation from taping,Surgery
Intervention groups
60 athlete patients were randomly allocated into 2 groups, 30 patients in each group. Group A patient were treated with Kinesio taping while Group B patients were treated with McConnell taping technique. Randomization of patients into groups were done by mean of lottery method. Taking in account an inclusion and exclusion criteria before enrolling them in this study. Informed consent was considered in written about their willingness in the study. Volunteers was provided with the detailed information i.e. both verbal and written regarding the study procedure. Both groups receive conventional therapy, that was TENS, ultrasound and quadriceps exercises
Main outcome variables
• Functional Activity was assessed by using lower extremity functional scale • Postural and Dynamic Control measured by star excursion balance test

General information

Reason for update
Acronym
PFPS
IRCT registration information
IRCT registration number: IRCT20200611047734N1
Registration date: 2020-06-17, 1399/03/28
Registration timing: retrospective

Last update: 2020-06-17, 1399/03/28
Update count: 0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
AYESHA RAZZAQ
Name of organization / entity
King Edward Medical University,Lahore
Country
Pakistan
Phone
+92 61 6521475
Email address
drayesharazzak@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-01, 1398/09/10
Expected recruitment end date
2020-06-01, 1399/03/12
Actual recruitment start date
2019-12-01, 1398/09/10
Actual recruitment end date
2020-06-01, 1399/03/12
Trial completion date
2020-06-01, 1399/03/12
Scientific title
Comparison of effects of Kinesio taping versus McConnell taping on function and dynamic postural control in athletes with patellofemoral pain syndrome
Public title
Comparison of effects of Kinesio taping versus McConnell taping on function and dynamic postural control in athletes with patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Referred athletes with chronic patellofemoral pain syndrome. • Patients diagnosed with chronic PFPS• Subject not received taping before• Subject not receiving any pain killer or medical treatment • Positive Clark’s test • Age: 18 to 40 years• Both gender
Exclusion criteria:
Patients with history of: • Ankle and hip pathology• Any other knee abnormality or arthritis• Lower limb fracture• Subject using corticosteroids • Pregnancy • Irritation from taping• Surgery
Age
From 18 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 30
30 patient diagnosed with PFPS was randomly allocated in each group
Actual sample size reached: 60
More than 1 sample in each individual
Actual sample size in each individual: 30
30 patient diagnosed with PFPS was randomly allocated in each group
Randomization (investigator's opinion)
Randomized
Randomization description
The patients having diagnosed patellofemoral pain syndrome was recruited in the study by convenient sampling, and the patients who fulfilled the inclusion and exclusion criteria was selected, with similar baseline characteristics. The consent was taken from the subjects to participate in the study. It was a single blinded trial in which the assessor was kept blind. The subjects was randomly assigned to one of two groups by using a lottery method, using a restricted randomization scheme to assure equal numbers in each group. Random allocation to all groups was ensured, from all study personnel and participants by entry of data.
Blinding (investigator's opinion)
Single blinded
Blinding description
it was a single blinded trial in which participant/ patients were kept blind about the 2 of treatment technique which was provided to them during management session.
Placebo
Not used
Assignment
Parallel
Other design features
Parallel groups, single blinded, single setting

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
institutional review board
Street address
1 km, Bhobatiyan chowk, Raiwind road
City
Lahore
Postal code
0544
Approval date
2019-12-01, 1398/09/10
Ethics committee reference number
IRB-UOL-FAHS/657/2019

Health conditions studied

1

Description of health condition studied
patellofemoral pain syndrome
ICD-10 code
M25.56
ICD-10 code description
Pain in knee

Primary outcomes

1

Description
• Functional Activity
Timepoint
Baseline and after 24 hour
Method of measurement
lower extremity functional scale

2

Description
• Postural and Dynamic Control
Timepoint
Baseline and after 24 hour
Method of measurement
Star excursion balance test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 60 athlete patients were randomly allocated into 2 groups, 30 patients in each group. Group A patient were treated with Kinesio taping. Taking in account an inclusion and exclusion criteria before enrolling them in this study. Informed consent was considered in written about their willingness in the study. Volunteers was provided with the detailed information i.e. both verbal and written regarding the study procedure. Both groups receive conventional therapy, that was TENS, ultrasound and quadriceps exercises. Assessment was done before and after the application of tape. For the baseline measure, Pre tape assessment, which was measured just before the application of tape, Post taping assessment after 24 hours while tape still in place and follow up measurement after 24 hours of tape removal. Pre tape assessment was used as baseline measurement. Excursion Balance Test (SEBT) was used for the measurement actual dynamic postural control. To measure the functional activity LEFS was be used. SEBT assessment was done in i.e. anterior, posteromedial, and posterolateral direction. Group A (Kinesio taping): - Kinesio taping plusTENS plus ultrasound plus quadriceps exercises. Dosage: - o K-taping for 24 hourso Ultrasound = 1MHZ, 0.8W/cm2, for 4 minutes o TENS= 100Hz, 50 µ s pulse, 20 minutes.o Quadriceps exercise = 10 times repetition
Category
Treatment - Devices

2

Description
Intervention group: 60 athlete patients were randomly allocated into 2 groups, 30 patients in each group. Group B patient were treated with McConnell taping. Taking in account an inclusion and exclusion criteria before enrolling them in this study. Informed consent was considered in written about their willingness in the study. Volunteers was provided with the detailed information i.e. both verbal and written regarding the study procedure. Both groups receive conventional therapy, that was TENS, ultrasound and quadriceps exercises. Assessment was done before and after the application of tape. For the baseline measure, Pre tape assessment, which was measured just before the application of tape, Post taping assessment after 24 hours while tape still in place and follow up measurement after 24 hours of tape removal. Pre tape assessment was used as baseline measurement. Excursion Balance Test (SEBT) was used for the measurement actual dynamic postural control. To measure the functional activity LEFS was be used. SEBT assessment was done in i.e. anterior, posteromedial, and posterolateral direction. Group B (McConnell taping): - McConnell taping+ TENS+ ultrasound+ quadriceps exercises. Dosage: - o M-taping for 24 hourso Ultrasound = 1MHZ, 0.8W/cm2, for 4 minutes o TENS= 100Hz, 50 µ s pulse, 20 minutes.o Quadriceps exercise = 10 times repetition
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Spine Physiotherapy Clinic, Sahiwal.
Full name of responsible person
Naeem Aslam
Street address
spine clinic, 21 main fateh sher road sahiwal
City
Sahiwal
Postal code
57000
Phone
+92 40 4462978
Email
naeemaslam693@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Umair Ahmad
Street address
1 km, Raiwind road
City
lahore
Postal code
0544
Phone
+92 42 35963421
Email
umairahmad@gmail.com
Grant name
student
Grant code / Reference number
NA
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Academic support Only
Proportion provided by this source
20
Public or private sector
Private
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
University of Lahore
Full name of responsible person
Naeem Aslam
Position
consultant physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
spine clinic, 21 main fateh sher road
City
Sahiwal
Province
punjab
Postal code
57000
Phone
+92 40 4462978
Email
naeemaslam693@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Arooj Fatima
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 km, Raiwind road
City
Lahore
Province
punjab
Postal code
0544
Phone
+92 42 35963421
Email
aruj43@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Naeem Aslam
Position
consultant physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
spine clinic, 21 Main Fateh sher road, Sahiwal
City
Sahiwal
Province
punjab
Postal code
57000
Phone
+92 40 4462978
Email
naeemaslam693@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Comparison of effects of Kinesio taping versus McConnell taping on function and dynamic postural control in athletes with patellofemoral pain syndrome
When the data will become available and for how long
It will be available after study completion and publication
To whom data/document is available
academic institute To researchers for study only.Patient data will not be shown
Under which criteria data/document could be used
under the usage with terms in which journal is accessed /processed for publication, and on request
From where data/document is obtainable
from the University office and Responsible supervisor and from journal we will process in future
What processes are involved for a request to access data/document
It will be only used in confidential way for improving research and benefit of humanity can call or mail
Comments
data can bee provided on request
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