comparison of the effect of a course of course of corrective exercises with and without foot orthosis on the improvement of pain and performance of patients with patellofemoral pain syndrome.
Comparison of the effect of a course of corrective exercises with and without foot orthosis on the improvement of pain and function of patellofemoral pain syndrome.
Design
Clinical trial with control group and, with parallel groups, double-blind, randomized, on 111 patients. Random allocation was used for randomization
Settings and conduct
he work was carried out in sports clubs and orthopedic clinics. The patients are randomly divided into three groups of 37 people using the Random Allocation software. The first patient who meets the entry criteria will be allocated treatments in the order of randomization.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1. Age range between 18 and 40 years
2. Having knee pain for at least 6 weeks or more
3. Having anterior knee pain with non-traumatic origin
4. Not having a history of injury and surgery on the spine and lower limbs
5. Exacerbation of pain with at least 2 of the following activities including: running, jumping, walking on a hill or stairs, sitting for a long time, kneeling, squatting
Exit criteria
If they have the following, they will be excluded from the study.
Knee meniscus and ligament or tendon damage, patella dislocation (patellar instability), Osgood Schlatter disease, Pelica syndrome, Larsen-Johnson syndrom, knee joint effusion.
Intervention groups
he first intervention group: includes a group of people with patellofemoral pain syndrome who receive a course of corrective exercise.
The second intervention group: includes a group of people with patellofemoral pain syndrome who receive a course of corrective exercise and foot orthosis.
The third intervention group: includes a group of people with patellofemoral pain syndrome who continue their normal lifestyle and do not receive any treatment.
Main outcome variables
pain and functional
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230604058380N1
Registration date:2023-07-28, 1402/05/06
Registration timing:prospective
Last update:2023-07-28, 1402/05/06
Update count:1
Registration date
2023-07-28, 1402/05/06
Registrant information
Name
mansoureh barati ashtiani
Name of organization / entity
Gilan University
Country
Iran (Islamic Republic of)
Phone
+98 918 698 9204
Email address
manbarati1377@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-21, 1402/05/30
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of a course of course of corrective exercises with and without foot orthosis on the improvement of pain and performance of patients with patellofemoral pain syndrome.
Public title
Comparison of the effect of a course of corrective exercises with and without foot orthosis on people with patellofemoral pain syndrome.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 18 and 40 years
Having knee pain for at least 6 weeks or more
Having anterior knee pain with non-traumatic origin
Not having a history of injury and surgery on the spine and lower limbs
Exacerbation of pain with at least 2 of the following activities including: running, jumping, walking on a hill or stairs, sitting for a long time, kneeling, squatting
Clark's test is positive
Exclusion criteria:
Knee meniscus and ligament or tendon injury
patellar dislocation (patellar instability)
Osgoodschlatter disease
Celica syndrome,
Larsen-Johnson syndrom
knee joint effusion
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided into three groups of 37 people using the Random Allocation software. From the first patient who meets the entry criteria, the allocation of treatments starts in the order of randomization, and the type of treatment is specified in each envelope. The treatment package in it will be implemented.(The envelopes are marked as A B C)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome evaluator is blind, so that he does not know how the subjects are assigned to the groups and what treatment intervention each group of subjects will receive. In this way, during the evaluation before and after the period of interventions, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.
Placebo
Not used
Assignment
Parallel
Other design features
NO
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gilan University of Medical Sciences
Street address
1st block, 13th floor, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between South Flank and Zarafshan, Quds town, Tehran
City
Rasht
Province
Guilan
Postal code
1467664961
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.GUILAN.REC.1402.021
Health conditions studied
1
Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Pain measurement before and after exercises and intervention
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
functional
Timepoint
Measurement of functional before and after exercises and intervention
Method of measurement
kujala scoring questionnaire
2
Description
functional
Timepoint
Measurement of functional before and after exercises and intervention
Method of measurement
Y balance test
3
Description
functional
Timepoint
Measurement of functional before and after exercises and intervention
Method of measurement
step down test at 30 second
4
Description
functional
Timepoint
Measurement of functional before and after exercises and intervention
Method of measurement
Single leg squat test
5
Description
functional
Timepoint
Measurement of functional before and after exercises and intervention
Method of measurement
bilateral squat test
6
Description
Q angle
Timepoint
Measurement of Q angle before and after exercises and intervention
Method of measurement
Measuring the angle Q with a goniometer
7
Description
Flat foot
Timepoint
Measurement before and after exercises and intervention
Method of measurement
Navicular drop
8
Description
Quality of life
Timepoint
Measurement before and after exercises and intervention
Method of measurement
Quality of life questionnaire (SF_36)
9
Description
functional
Timepoint
Measurement of functional before and after exercises and intervention
Method of measurement
anteromidial lunge test
10
Description
disability
Timepoint
Measurement disability of before and after exercises and intervention
Method of measurement
Vanukurf questionnaire
Intervention groups
1
Description
Intervention group: The first intervention group includes a group that receives corrective exercises.
Category
Rehabilitation
2
Description
Intervention group: The second intervention group receives a corrective exercise group with a foot orthosis.
Category
Rehabilitation
3
Description
Control group: These people continue their way of life as usual.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Corrective movements center and sports clubs
Full name of responsible person
Behnaz Tabatabai
Street address
Khoram Street, Hakim building, third floor
City
Arak
Province
Markazi
Postal code
3814813685
Phone
+98 903 499 0769
Email
manbarati1377@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of guilan
Full name of responsible person
Farhad Rahmani Nia
Street address
Kilometer 5, Grand University, Qazvin-Rasht road
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0274
Email
pr@guilan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of guilan
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
Gilan University
Full name of responsible person
mansoureh barati ashtiani
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises
Street address
Kilometer 5 of Qazvin Highway - Rasht, Faculty of Physical Education and Sports, Pilan
City
rasht
Province
Guilan
Postal code
4199613776
Phone
+98 903 499 0769
Fax
+98 13 3369 0451
Email
manbarati1377@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Gilan
Full name of responsible person
Hasan Daneshmandi
Position
full Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercises
Street address
Kilometer 5, Bezgarah, Qazvin, Rasht, Faculty of Sports Sciences and Physical Education, Gilan
City
Rasht
Province
Guilan
Postal code
guilan.central.lab@g
Phone
0133369027
Email
daneshmandi_ph@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
the university of guilan
Full name of responsible person
mansoureh barati ashtiani
Position
student
Latest degree
Master
Other areas of specialty/work
Corrective exercises
Street address
Kilometer 5 of Qazvin Highway - Rasht, Faculty of Physical Education and Sports, Pilan
City
rasht
Province
Guilan
Postal code
4199613776
Phone
+98 903 499 0769
Email
guilan.central.lab@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD