The efficacy of biofeedback exercises of hip abductors and external rotators muscles on pain and muscle electromyographic activity in people with patellofemoral pain syndrome
The efficacy of biofeedback exercises of hip abductors and external rotators muscles on pain and muscle electromyographic activity in people with patellofemoral pain syndrome
Design
Clinical trial with an intervention group and a control group, with parallel groups, double blinded, randomly constructed, on 20 people in each group
Settings and conduct
Setting: School of Rehabilitation., Shahid Beheshti University of Medical Sciences, Tehran. In this study, eligible people will be included among the patients with patellofemoral pain syndrome and will be randomly divided into two intervention and control groups. Treatment interventions for each group will be carried out in eight weeks. Outcome assessment and data analysis will be performed by another colleague who is blinded to group assignment. Also, the patients will be blinded to the treatments of each group. Data collection tools will include visual analog scale, dynamometer and surface electromyography devices.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with patellofemoral pain syndrome with pain at least 3 on the visual analog scale. Exclusion criteria: history of patella dislocation and knee surgery.
Intervention groups
Intervention group: biofeedback exercises of hip abductors and external rotators muscles with routine physiotherapy treatments (stretching exercises, gluteal and quadriceps isometric exercises, electrotherapy including conventional tens). Control group: only routine physiotherapy treatments (stretching exercises, gluteal and quadriceps isometric exercises, electrotherapy including conventional tens). In both groups, the interventions will be conducted for eight weeks and three sessions per week.
Main outcome variables
Pain intensity; maximum muscle isometric contraction force; Muscle electromyographic activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221214056819N1
Registration date:2023-11-01, 1402/08/10
Registration timing:prospective
Last update:2023-11-01, 1402/08/10
Update count:0
Registration date
2023-11-01, 1402/08/10
Registrant information
Name
mehdi Banan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 5422
Email address
mehdibanan182@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of biofeedback exercises of hip abductors and external rotators muscles on pain and muscle electromyographic activity in people with patellofemoral pain syndrome
Public title
The effect of biofeedback exercises on anterior knee pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with patellofemoral pain syndrome with pain at least 3 on the visual analog scale
Knee pain when running, jumping, sitting and standing up
Exclusion criteria:
History of patella dislocation
History of knee surgery
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized method: balanced randomized blocks. Random concealment: sealed envelope. Randomization method: code of the intervention group: A code of the control group: B. Due to having two groups, the determined blocks are of four, so that the total number of possible permutations of four is 6, including: ABAB, ABBA, BAAB, BABA, AABB, BBAA. To create a random sequence, we will number the possible blocks (6 blocks) from 1 to 6, we will select the block numbers from the random number table, and based on these numbers, we will determine the sequence of blocks in each group. Each of these codes representing the treatment group of each patient is placed in a sealed envelope, then patients will be assigned to one of the envelopes in order of number. In this study, the unit of randomization is the individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
The main researcher is blinded to the selection and randomization of participants, and assigning groups will be done by another colleague. Treatment for the intervention group will be done on even days of the week and treatment for the control group will be done on odd days of the week, so the participants will be blinded to their treatment and group assignment. Data collection and analysis after the completion of the interventions will be done by another colleague who is blind to group assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committees of Vice Chancellor in Research Affairs Shahid Beheshti University of Medic
Street address
Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1117
Health conditions studied
1
Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Pain intensity
Timepoint
Measurement of pain intensity at the beginning of the study (before the intervention), at the end of the study (8 weeks after the intervention)
Method of measurement
Visual Analog Scale
2
Description
Maximum muscle isometric contraction force
Timepoint
Measurement of maximum muscle isometric contraction force at the beginning of the study (before the intervention) and at the end of the study (8 weeks after the intervention)
Method of measurement
Hand dynamo-meter
3
Description
Muscle electromyographic activity
Timepoint
Measurement of muscle electromyographic activity at the beginning of the study (before the intervention) and at the end of the study (8 weeks after the intervention)
Method of measurement
Surface electromyography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: biofeedback exercises of hip abductors and external rotators muscles with routine physiotherapy treatments (stretching exercises, gluteal and quadriceps isometric exercises, electrotherapy including conventional tens). The interventions will be conducted for eight weeks and three sessions per week.
Category
Rehabilitation
2
Description
Control group: Routine physiotherapy treatments (stretching exercises, gluteal and quadriceps isometric exercises, electrotherapy including conventional tens). The interventions will be conducted for eight weeks and three sessions per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation., Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mohsen Roostayi
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1722
Email
mohsen42@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velen
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdi Banan
Position
PhD candidate Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 8863 1084
Email
mehdibanan182@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Khalkhali Zavieh
Position
Associate professor of Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1722
Email
minoo_kh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdi Banan
Position
PhD candidate Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 8863 1084
Email
mehdibanan182@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
All above will be published in the article.
When the data will become available and for how long
After the article publication
To whom data/document is available
Researchers and students in academic centers
Under which criteria data/document could be used
Other researchers and therapists in the rehabilitation and medical field can use this use the data of this study after the article publication.
From where data/document is obtainable
After the article publication, people can find the article by searching in internet and access the data.
What processes are involved for a request to access data/document
After the article publication, people can find the article by searching in internet and access the data.