Effect of Hip Abductor and External Rotator Muscles Strengthening on Patellofemoral Pain Symptoms, Hip muscles Strength, and Lower Extremity Kinematics in Patients with Patellofemoral Pain Syndrome: A Randomized Controlled Trial
Investigating the effect of hip abductor and external rotator muscle strengthening on patellofemoral pain syndrome symptoms, hip muscles strength, and lower extremity kinematics.
Design
Randomized controlled trial with blinded outcome assessment, with a sample size of 35, restricted randomization with concealed randomization sequence
Settings and conduct
The experimental group completed hip abductor and external rotator muscles strengthening exercises for 12 weeks with thera-band, in physical therapy unit of Shahid Dastgheyb Hospital in Shiraz, Iran, for three times per week and 30 minutes per session. Every three weeks the exercise was progressed by increasing the repetitions or changing the thera-band with a more resistant one.
Participants/Inclusion and exclusion criteria
Patients with patellofemoral pain syndrome; 18-45 years old; history of having pain for at least 3 months and 3 of 10 in VAS system in daily activities; without lower extremity surgery, meniscal or ligamentus injuries, and participating in sport activities.
Intervention groups
The intervention group did hip abductor and external rotator muscles strengthening exercises by thera-band, while control group received no exercises.
Main outcome variables
pain; health status; hip abductor and external rotator muscles; lower extremity kinematics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190816044538N1
Registration date:2019-12-06, 1398/09/15
Registration timing:retrospective
Last update:2019-12-06, 1398/09/15
Update count:0
Registration date
2019-12-06, 1398/09/15
Registrant information
Name
Narjes Jamali
Name of organization / entity
Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 71 3228 8064
Email address
narjes.jamali84@spr.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2019-10-02, 1398/07/10
Actual recruitment start date
2019-07-06, 1398/04/15
Actual recruitment end date
2019-10-12, 1398/07/20
Trial completion date
2019-10-17, 1398/07/25
Scientific title
Effect of Hip Abductor and External Rotator Muscles Strengthening on Patellofemoral Pain Symptoms, Hip muscles Strength, and Lower Extremity Kinematics in Patients with Patellofemoral Pain Syndrome: A Randomized Controlled Trial
Public title
Effect of Hip Muscles Strengthening Exercises on Anterior Knee Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with patellofemoral pain syndrome
Having pain of 3 in VAS system during following activities: stair descending/ascending, prolonged sitting, running, jumping and squatting
Having pain in knee joint for at least 3 months
Exclusion criteria:
Having pain less than 3 months
History of lower extremity surgery
Participating in exercise program
Meniscal or ligamentus injury without any surgery
Flat foot
Prior patella dislocation
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
35
Randomization (investigator's opinion)
Randomized
Randomization description
In this study "restricted randomization", the type of "random allocation rule", was used. With a sample size of 35 persons, 18 papers of experimental group and 18 papers of control group were put in an opaque bag and then randomly assigned to the participants without substitution, and the sequence was registered. The participants and the researcher were unaware of random sequence (Allocation concealment).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study an expert physiotherapist, who was blind to group assignment, was invited to evaluate the variables in pre and post test stages.
The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
3
Description
Hip joint muscles strength
Timepoint
Pre-intervention and after 12 weeks
Method of measurement
Hand-held dynamo meter
4
Description
Lower extremity kinematics
Timepoint
Pre-intervention and after 12 weeks
Method of measurement
2-dimensional motion analyze
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Doing hip abductor and external rotator muscles strengthening exercises with thera-band during 12 weeks, three times per week and 30 minutes per session under supervision of an expert physiotherapist
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
Not applicable
Title and more details about the data/document
All data can be shared after making the participants unrecognizable.
When the data will become available and for how long
Start of access period, 6 months after publishing the results
To whom data/document is available
Data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Data will not be accessible to other people.
From where data/document is obtainable
People can write to the following mail address to receive the data they want:
jamalinarjes84@gmail.com
What processes are involved for a request to access data/document
After correspondence with the appended mail address and confirmation of the applicant's scientific position, the data will be made available to him/her as soon as possible.