Comparison of the effect of Real-time Feedback and Electromyography Biofeedback compared with Exercise therapy on Fear of movement, Clinical prediction rules and Stair-descent Kinematics in Subjects with Patellofemoral Pain Syndrome
Comparison of the effect of Real-time Feedback and Electromyography Biofeedback compared with Exercise therapy on Fear of movement, Clinical prediction rules and Stair-descent Kinematics in Subjects with Patellofemoral Pain Syndrome
Design
Clinical trial with parallel groups, Double-blind and randomized.
Settings and conduct
Ninety-three patients with patellofemoral pain syndrome who were included in the study were randomly divided into three groups. All three groups will do their specific exercises three days a week for eight weeks. The total duration of the training session will be 60 minutes, which is the initial 10 to 15 minutes of warm-up and stretching movements to prevent possible injuries to the The musculoskeletal system will be allocated. The main exercises will be performed for 30 to 40 minutes. During these exercises, each subject will rest for one minute between each set and one to two minutes between each movement.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Retropatellar knee pain present for at least 2 mo during at least 2 of the following activities : Ascending / descending stairs Hopping / jogging Prolonged sitting with flexed knees Kneeling Squatting.Pain rated as at least 3 cm within the week before participation on the 10-cm visual analogue pain scale. Clark test is positive. Exclusion criteria: History of knee surgery. History of low back, hip, or ankle injury within the 6 mo before participation. Anterior knee pain of secondary origin.
Intervention groups
Real-time Feedback with Exercise therapy group, Electroencephalographic Biofeedback with Exercise therapy group - Control group
Main outcome variables
Fear of movement, Predictive rules (Pain, Performance, Strength of the Knee extensor muscles and Hip muscles, Endurance of the Trunk muscles), Kinematics of the lower limbs
General information
Reason for update
Acronym
PFPS
IRCT registration information
IRCT registration number:IRCT20200628047946N1
Registration date:2020-07-16, 1399/04/26
Registration timing:prospective
Last update:2020-07-16, 1399/04/26
Update count:0
Registration date
2020-07-16, 1399/04/26
Registrant information
Name
saeedeh musavi
Name of organization / entity
Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 21 2612 1726
Email address
std_musavimoghadam@khu.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-30, 1399/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Real-time Feedback and Electromyography Biofeedback compared with Exercise therapy on Fear of movement, Clinical prediction rules and Stair-descent Kinematics in Subjects with Patellofemoral Pain Syndrome
Public title
Comparison of the effect of Real-time Feedback and Electromyography Biofeedback compared with Exercise therapy on Fear of movement, Clinical prediction rules and Stair-descent Kinematics in Subjects with Patellofemoral Pain Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Retropatellar knee pain present for at least 2 mo during at least 2 of the following activities : Ascending / descending stairs Hopping / jogging Prolonged sitting with flexed knees Kneeling Squatting
Pain on palpation of 1 of the following , medial or lateral patellar facets, Anterior portion of the medial or lateral femoral condyle Patellar tendon
Pain rated as at least 3 cm within the week before participation on the 10-cm visual analogue pain scale
Clark test is positive
Exclusion criteria:
History of knee surgery
Severe abnormalities in the lower limbs
Any neurologic injury or disease that would influence gait or balance
History of low back, hip, or ankle injury within the 6 mo before participation
Insidious onset of knee pain not related to trauma
Currently involved in physical therapy or has undergone physical therapy for a lower extremity injury within the 6 mo before participation
Anterior knee pain of secondary origin
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomly divided into three homogeneous groups including two intervention groups and a control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, Researchers, Outcome evaluators and data analyzer are kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kharazmi University
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvarei Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Approval date
2020-01-12, 1398/10/22
Ethics committee reference number
IR.KHU.REC.1398.042
Health conditions studied
1
Description of health condition studied
patellofemoral pain syndrom
ICD-10 code
M22.2X
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Fear of movement
Timepoint
Before and after the intervention
Method of measurement
Fear of movement questionnaire
2
Description
Pain
Timepoint
Before and after the intervention
Method of measurement
VAS
3
Description
Function
Timepoint
Before and after the intervention
Method of measurement
WOMAC Functional Questionnaire
4
Description
Strength of Knee extensor muscles and Hip muscles
Timepoint
Before and after the intervention
Method of measurement
Manual dynamometer
5
Description
Endurance of Trunk muscles
Timepoint
Before and after the intervention
Method of measurement
Planck test
6
Description
Lower limb kinematics
Timepoint
Before and after the intervention
Method of measurement
3D motion analysis system
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 45 minutes of therapeutic exercises including strengthening the central muscles of the trunk and thigh and knee muscles in each session.
Category
Rehabilitation
2
Description
Intervention group: 45 minutes of therapeutic exercises including strengthening the central muscles of the trunk and thigh and knee muscles with Real-time feedback in each session.
Category
Rehabilitation
3
Description
Intervention group: 45 minutes of therapeutic exercises including strength training of the central muscles of the trunk and muscles of the thighs and knees with biofeedback electromyography in each session.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kharzmi University Health and Wellness Center
Full name of responsible person
Seyedeh Saeedeh Mousavi Moghaddam Qaleh Zoo
Street address
Center for Human Movement Sciences Kharazmi university Mirdamad, Sout Razan Street, Hesari Street, Keshvarei Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com
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 2222 8001
Email
letafatkaramir@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
No
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
Seyedeh Saeedeh Mousavi Moghaddam Qaleh Zoo
Position
Master student of corrective exercise and sport injury prevention
Latest degree
Master
Other areas of specialty/work
Corrective exercise and sports injury prevention
Street address
Center for Human Movement Sciences Kharazmi university Mirdamad, Sout Razan Street, Hesari Street, Keshvarei Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2222 8001
Email
smusavi73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center for Human Movement Sciences Kharazmi University
Full name of responsible person
Seyedeh Saeedeh Mousavi Moghaddam Qaleh Zoo
Position
Master student of corrective exercise and sport injury prevention
Latest degree
Master
Other areas of specialty/work
Corrective exercise and sports injury prevention
Street address
Center for Human Movement Sciences Kharazmi university Mirdamad, Sout Razan Street, Hesari Street, Keshvarei Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2222 8001
Email
smusavi73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Physical Education, Kharazmi University
Full name of responsible person
Seyedh Saeedeh Musavi Moghadam Qole Zoo
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, Keshvarei Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2222 8001
Email
smusavi73@gmail.com
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 article.
When the data will become available and for how long
The date of access is November 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. Only the results are presented as a scientific article.