Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Design
Randomized control trial , with parallel groups, Double blinded, Randomized
Settings and conduct
Seventy five patients with patellofemoral pain syndrome who met the inclusion criteria will be allocated randomly into three intervention groups .Treatment in all three groups will be three
times a week for 6 weeks totally In each group, the patients will warmed up for 10 minutes and then will practiced for 30 minutes. Finally, 5 minutes cool down will be applied.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-they had anterior knee pain for at least 3 months
2-reported increase pain for 2 or more activities These activities included ascending and descending stairs, squatting, kneeling, long periods of sitting
3- pain on palpation of the medial and/or lateral facet of the patella.4- positive Clarc Test
Exclusion criteria: neurological disorder; injury to the hip, ankle, or lumbosacral region; rheumatoid arthritis; heart condition; previous surgery involving the lower extremities; or if they were pregnant. other knee pathologies, such as patellar instability,
patellofemoral dysplasia, meniscal or ligament tears, osteoarthritis, or tendinopathies,those who exhibited a leg length difference of more than 1 cm when measured in supine, from the anterior superior iliac spine to the medial malleolus.
Intervention groups
1- Hip and Knee strengthening with internal instruction exercise 2-Hip and Knee strengthening with external instruction exercise 3- Hip and Knee strengthening exercise alone
Main outcome variables
pain, Function, muscle strength of the Hip abductors and external rotators, dynamic knee valgus angle, lower limb kinematics during walking
General information
Reason for update
Acronym
PFPS
IRCT registration information
IRCT registration number:IRCT20150503022068N3
Registration date:2020-01-05, 1398/10/15
Registration timing:registered_while_recruiting
Last update:2020-01-05, 1398/10/15
Update count:1
Registration date
2020-01-05, 1398/10/15
Registrant information
Name
amir letafatkar
Name of organization / entity
kharazmi university
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 8084
Email address
amir.letafatkar@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-31, 1398/10/10
Expected recruitment end date
2020-03-03, 1398/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Public title
Comparison of the effects of hip and knee strengthening with internal and external instruction exercises on pain and performance in patients with patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
they had anterior knee pain for at least 3 months
reported increase pain for 2 or more activities These activities included ascending and descending stairs, squatting, kneeling, long periods of sitting
pain on palpation of the medial and/or lateral facet of the patella.
positive Clarc Test
Exclusion criteria:
neurological disorder
injury to the hip, ankle, or lumbosacral region
heart condition
previous surgery involving the lower extremities
if theywere pregnant
other knee pathologies, such as patellar instability,patellofemoral dysplasia, meniscal or ligament tears
those who exhibited a leg length difference of more than 1 cm when measured in supine, from the anterior superior iliac spine to the medial malleolus.
osteoarthritis, or tendinopathies
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected according to the criteria for entering the research and are randomly divided into three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome evaluator, Participants, Researcher and data analyzer are kept blind. The assessor was blinded to the group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
None
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The study was approved by the ethical committee (IRB) of kharazmi University. data were collected in
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street ,Keshvari Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Approval date
2019-12-15, 1398/09/24
Ethics committee reference number
IR.KHU.REC.1398.034
Health conditions studied
1
Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M22.2X
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Pain
Timepoint
Before and after the intervention
Method of measurement
VAS
2
Description
Function
Timepoint
Before and after the intervention
Method of measurement
Kujala questionnaire
3
Description
Muscle strength of the Hip abductors and external rotators
Timepoint
Before and after the intervention
Method of measurement
handheld dynamometer
4
Description
dynamic knee valgus angle
Timepoint
Before and after the intervention
Method of measurement
using two-dimensional motion analysis systems
5
Description
lower limb kinematics during walking
Timepoint
Before and after the intervention
Method of measurement
using two-dimensional motion analysis systems
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Thirty minutes of hip and knee strengthening each session
Category
Rehabilitation
2
Description
Intervention group: Thirty minutes of hip and knee strengthening with internal instruction exercises each session
Category
Rehabilitation
3
Description
Intervention group: Thirty minutes of hip and knee strengthening with external instruction exercises each session
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kharazmi University Health and Wellness Center
Full name of responsible person
Fatemeh Aghakeshizadeh
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2222 8001
Email
std_aghakeshizadefateme@khu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Amir Letafatkar
Street address
-
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 4471 8356
Email
letafatkaramir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi University
Proportion provided by this source
20
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
Center for Human Movement Sciences Kharazmi University
Full name of responsible person
Fatemeh Aghakeshizadeh
Position
Master student of Corrective exercise and sport injury prevention
Latest degree
Master
Other areas of specialty/work
Corrective exercise and sport injury prevention
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street ,Keshvari Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2222 8001
Fax
Email
std_aghakeshizadefateme@khu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center for Human Movement Sciences Kharazmi University
Full name of responsible person
Fatemeh Aghakeshizadeh
Position
Master student of Corrective exercise and sport injury prevention
Latest degree
Master
Other areas of specialty/work
Corrective exercise and sport injury prevention
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street ,Keshvari Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2222 8001
Fax
Email
std_aghakeshizadefateme@khu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Center for Human Movement Sciences Kharazmi University
Full name of responsible person
Fatemeh Aghakeshizadeh
Position
Master student of Corrective exercise and sport injury prevention
Latest degree
Master
Other areas of specialty/work
Corrective exercise and sport injury prevention
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street ,Keshvari Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
-
Fax
Email
std_aghakeshizadefateme@khu.ac.ir
Web page address
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as dependent variables,The average of all samples, can be shared in scientific articles.
When the data will become available and for how long
The date of access is April 2020.
To whom data/document is available
Personal information is confidential and General outcomes in paper form Available to everyone.
Under which criteria data/document could be used
Information is not available to anyone.General outcomes in paper form Available to everyone.