History
# Registration date Revision Id
2 2023-11-28, 1402/09/07 287786
1 2022-05-28, 1401/03/07 227722
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  • General information

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    2022-01-10, 1400/10/20
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    2023-07-23, 1402/05/01
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    2023-07-23, 1402/05/01
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    Change in the secondary outcome and the number of study samples due to research conditions
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    تغییر در پیامد ثانویه و تعداد افراد مورد مطالعه بدلیل شرایط تحقیق
    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
    The effect of movement system impairment-based classification treatment compared to routine physiotherapy on pain, disability, and alignment and movement impairments in individuals with tibiofemoral rotation syndrome: A randomized controlled trial
    مقایسه تاثیر دو روش درمان بر اساس دسته بندی نقص سیستم حرکتی و فیزیوتراپی رایج در افراد 18-40 سال مبتلا به سندروم چرخش رانی-ساقی
    تأثیر درمان مبتنی بر دسته بندی بر اساس نقص سیستم حرکتی در مقایسه با فیزیوتراپی رایج بر درد، ناتوانی، و اختلالات راستا و حرکت در افراد مبتلا به سندرم چرخش رانی-ساقی: کارآزمایی بالینی تصادفی شده
    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
    age between 18 and 40 years
    history of sudden or gradual pain at the knee complex or surrounding tissues
    a pain intensity of at least 3 points measured using a 0- to 10-point visual analog scale
    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
    محدوده سنی 18 تا 40 سال
    تشخیص اختلال اکتسابی چرخش رانی-ساقی با والگوس/واروس در معاینه اولیه
    درد در هر یک از ساختارهای زانو با شروع تدریجی برای مدت حداقل یک ماه و با شدت > 3 و <6 بر اساس معیار دیداری درد
    درد حین فعالیت هایی که با بارگذاری بر روی زانوی خم شده همراه اند؛ مانند: دویدن، پرش، اسکات زدن، بالا و پایین رفتن از پلکان
    سواد خواندن و نوشتن
    توانایی درک زبان فارسی
    سن بین 18 تا 40 سال
    سابقه درد ناگهانی یا تدریجی در مجموعه زانو یا بافت های اطراف
    شدت درد حداقل 3 نقطه با استفاده از مقیاس 0 تا 10 نقطه ای دیداری شدت درد
    درد حین فعالیت هایی که با بارگذاری بر روی زانوی خم شده همراه اند؛ مانند: دویدن، پرش، اسکات زدن، بالا و پایین رفتن از پلکان
    سواد خواندن و نوشتن
    توانایی درک زبان فارسی
  • Health conditions studied

    #1
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    knee pain
    Knee osteoarthritis
    زانو درد
    استئوآرتریت زانو
    #2
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    Patellofemoral pain
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    درد مفصل پاتلوفمورال
  • Primary outcomes

    #1
    Before and immediately after the intervention
    over the previous 24 hours and 1 week ago and immediately after the intervention
    قبل و بلافاصله پس از اتمام مداخله
    24 ساعت گذشته و یک هفته قبل و بلافاصله پس از اتمام مداخله
    #2
    Disability/ Functional limitations
    Disability
    ناتوانی/ محدودیت عملکردی
    ناتوانی
  • Secondary outcomes

    #1
    Quadriceps-anglequadriceps angle
    Alignment and movement impairments
    زاویه کوادریسپس
    نقایص ساختاری و حرکتی
    Goniometer
    alignment and movement impairments data form
    گونیومتر
    فرم معاینه نقایص ساختاری و حرکتی
  • Intervention groups

    #1
    گروه کنترل فعال: درمان رایج فیزیوتراپی
    گروه کنترل فعال: درمان فیزیوتراپی رایج

Protocol summary

Study aim
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
Change in the secondary outcome and the number of study samples due to research conditions
Acronym
IRCT registration information
IRCT registration number: IRCT20210505051181N3
Registration date: 2022-05-28, 1401/03/07
Registration timing: registered_while_recruiting

Last update: 2023-12-09, 1402/09/18
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
2022-01-10, 1400/10/20
Actual recruitment end date
2023-07-23, 1402/05/01
Trial completion date
2023-07-23, 1402/05/01
Scientific title
The effect of movement system impairment-based classification treatment compared to routine physiotherapy on pain, disability, and alignment and movement impairments in individuals with tibiofemoral rotation syndrome: A randomized controlled trial
Public title
Movement System Impairment classification approach at knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 and 40 years history of sudden or gradual pain at the knee complex or surrounding tissues a pain intensity of at least 3 points measured using a 0- to 10-point visual analog scale 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
Actual sample size reached: 22
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

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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 osteoarthritis
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Patellofemoral pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain intensity
Timepoint
over the previous 24 hours and 1 week ago and immediately after the intervention
Method of measurement
Visual Analog Scale

2

Description
Disability
Timepoint
Before and immediately after the intervention
Method of measurement
Kujala Questionnaire

Secondary outcomes

1

Description
Alignment and movement impairments
Timepoint
Before and immediately after the intervention
Method of measurement
alignment and movement impairments data form

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
Full name of responsible person
Dr. Mehrnaz Kajbafvala
Street address
adadkaran St., ShahNazari Ave, Mother square, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2304 6688
Email
rehab@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keyvani
Street address
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
Comments
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