Protocol summary
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Study aim
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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
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Design
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Randomized control trial , with parallel groups, Double blinded, Randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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pain, Function, muscle strength of the Hip abductors and external rotators, dynamic knee valgus angle, lower limb kinematics during walking
General information
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Reason for update
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Acronym
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PFPS
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IRCT registration information
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IRCT registration number:
IRCT20150503022068N3
Registration date:
2020-01-05, 1398/10/15
Registration timing:
registered_while_recruiting
Last update:
2020-05-25, 1399/03/05
Update count:
1
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Registration date
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2020-01-05, 1398/10/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-12-31, 1398/10/10
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Expected recruitment end date
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2020-03-03, 1398/12/13
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
75
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples are selected according to the criteria for entering the research and are randomly divided into three groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Outcome evaluator, Participants, Researcher and data analyzer are kept blind. The assessor was blinded to the group allocation.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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None
Ethics committees
1
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Ethics committee
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Approval date
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2019-12-15, 1398/09/24
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Ethics committee reference number
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IR.KHU.REC.1398.034
Health conditions studied
1
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Description of health condition studied
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Patellofemoral pain syndrome
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ICD-10 code
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M22.2X
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ICD-10 code description
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Patellofemoral disorders
Primary outcomes
1
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Description
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Pain
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Timepoint
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Before and after the intervention
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Method of measurement
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VAS
2
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Description
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Function
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Timepoint
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Before and after the intervention
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Method of measurement
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Kujala questionnaire
3
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Description
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Muscle strength of the Hip abductors and external rotators
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Timepoint
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Before and after the intervention
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Method of measurement
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handheld dynamometer
4
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Description
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dynamic knee valgus angle
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Timepoint
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Before and after the intervention
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Method of measurement
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using two-dimensional motion analysis systems
5
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Description
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lower limb kinematics during walking
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Timepoint
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Before and after the intervention
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Method of measurement
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using two-dimensional motion analysis systems
Intervention groups
1
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Description
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Control group: Thirty minutes of hip and knee strengthening each session
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Category
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Rehabilitation
2
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Description
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Intervention group: Thirty minutes of hip and knee strengthening with internal instruction exercises each session
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Category
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Rehabilitation
3
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Description
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Intervention group: Thirty minutes of hip and knee strengthening with external instruction exercises each session
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kharazmi University
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Proportion provided by this source
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20
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Only part of the data, such as dependent variables,The average of all samples, can be shared in scientific articles.
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When the data will become available and for how long
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The date of access is April 2020.
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To whom data/document is available
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Personal information is confidential and General outcomes in paper form Available to everyone.
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Under which criteria data/document could be used
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Information is not available to anyone.General outcomes in paper form Available to everyone.
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From where data/document is obtainable
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Fatemeh Aghakeshizadeh Phone: 09142366537 Email: std_aghakeshizadefateme@khu.ac.ir
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What processes are involved for a request to access data/document
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Comments
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