Comparison of the effect of two treatment methods based on the movement system impairment classification and routine physiotherapy among people between 18 to 40 years old with tibiofemoral rotation syndrome
Comparision of the effect of two treatment methods based on the movement system impairment classification and routine physiotherapy among people between 18 to 40 years old with tibiofemoral rotation syndrome
Design
Clinical trial with two groups, Parallel groups, single-blinded, randomized, on the 40 patients, block randomization with blocks of 4 by using the Randomization website
Settings and conduct
This study will be performed in the IUMS School of Rehabilitation Science. participants after performing the examinations, during the block randomization process, are placed in one of two treatment groups, including treatment based on a MSI and routine physiotherapy. Primary and secondary outcomes will be recorded before and immediately after the measurement sessions and the resulting data will be recorded for statistical analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages of 18 to 40 years, Diagnosis of acquired TFRval/var, Pain in any structures of the knee with gradual onset for at least one month and with Intensity greater than 3 and less than 6, Pain during activities that include loading on a flexed knee. Exclusion criteria:Musculoskeletal injuries other than patellofemoral pain; such as: meniscus & ligamentous injury, history of patellar dislocation, severe osteoporosis, progressive neurological disorders, lumbosacral radiculopathies, History of any traumatic injury in the last 6 months, History of any lower limb surgery in the last 6 months Any specific deformity in the spine and lower extremities, Complaints of pain in the other joints of the lower limbs, Constant severe pain that interferes with the testing process
Intervention groups
group1: Movement System Impairment based treatment
group2: routine physiotherapy treatment
Main outcome variables
Pain intensity, Disability/ limitation of function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210505051181N3
Registration date:2022-05-28, 1401/03/07
Registration timing:prospective
Last update:2022-05-28, 1401/03/07
Update count:1
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
Mehrnaz Kajbafvala
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6688
Email address
kajbafvala.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two treatment methods based on the movement system impairment classification and routine physiotherapy among people between 18 to 40 years old with tibiofemoral rotation syndrome
Public title
Movement System Impairment classification approach at knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages of 18 to 40 years
Diagnosis of acquired TFRval/var at initial examination
Pain in each of the knee structures with gradual onset for at least one month and with severity> 3 and <6 based on VAS
Pain during activities that include loading on a flexed knee; Such as: running, jumping, squatting, climbing and descending stairs
Literacy for reading and writing
Ability to understand Persian language
Exclusion criteria:
Musculoskeletal injuries other than patellofemoral pain; such as: meniscus injury, ligamentous injury, history of patellar dislocation, severe osteoporosis, progressive neurological disorders, lumbosacral radiculopathies
History of any traumatic injury in the last 6 months
History of any lower limb surgery in the last 6 months
Any specific deformity in the spine and lower extremities; such as: scoliosis, kyphosis, femoral anteversion, tibial torsion
Complaints of pain in the other joints of the lower limbs
Constant severe pain that interferes with the testing process
Taking the analgesic and anti-inflammatory drugs during the study
The history of malignancy, cardiovascular disease
Pregnancy
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After initial evaluations, peoples that have inclusion criteria and do not have exclusion criteria will be divided into two groups of intervention (based on movement disorder) and active control (routine physiotherapy) through block randomization method and creating random blocks of 4. Creating a random sequence will be done using the Randomization website. The person who creates the random sequence is not involved in any other stage of the investigation.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, which included a comparison of two different treatment approaches (intervention group based on the movement system impairment classification approach and active control group including routine physiotherapy); Participants are blind to being in an active intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-07-17, 1400/04/26
Ethics committee reference number
IR.IUMS.REC.1400.336
Health conditions studied
1
Description of health condition studied
knee pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain intensity
Timepoint
Before and immediately after the intervention
Method of measurement
Visual Analog Scale
2
Description
Disability/ Functional limitations
Timepoint
Before and immediately after the intervention
Method of measurement
Kujala Questionnaire
Secondary outcomes
1
Description
Quadriceps-anglequadriceps angle
Timepoint
Before and immediately after the intervention
Method of measurement
Goniometer
Intervention groups
1
Description
Intervention group: Movement System Impairment based treatment
Category
Rehabilitation
2
Description
Active control group: routine physiotherapy treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of rehabilitation, Iran University of Medical Sciences
Vice chancellor for research and technology, 5 the floor, the central building, Iran University of Medical Sciences, between shahid Chamran and Sheikh Fazlollah Nouri Highways Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyyedeh Forouzan Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, School of Rehabilitation Science, Iran University of Medical Sciences, Madadkaran St., ShahNazari Ave, Mother square, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
mousavi.forouzan1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Kajbafvala
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Dastgerdi (Zafar) Ave, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6688
Email
kajbafvala.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyedeh Forouzan Mousavi
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, School of Rehabilitation Science, Iran University of Medical Sciences, Madadkaran St., ShahNazari Ave, Mother square, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
mousavi.forouzan1995@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data or results of the present study will be presentation in an article or some articles that will be published, also will be available through correspondence with the corresponding author
When the data will become available and for how long
After completing the present study and publishing the resulting article or articles
To whom data/document is available
All researchers in the field of the present study
Under which criteria data/document could be used
With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the Iran University of Medical Sciences
From where data/document is obtainable
The corresponding author of the article or articles derived from the study
What processes are involved for a request to access data/document
Written request from the author responsible for the present review after the publication of the article or articles