Protocol summary
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Study aim
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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
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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group1: Movement System Impairment based treatment
group2: routine physiotherapy treatment
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Main outcome variables
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Pain intensity, Disability/ limitation of function
General information
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Reason for update
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Change in the secondary outcome and the number of study samples due to research conditions
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Acronym
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IRCT registration information
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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
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Registration date
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2022-05-28, 1401/03/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-06-22, 1401/04/01
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Expected recruitment end date
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2022-09-22, 1401/06/31
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Actual recruitment start date
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2022-01-10, 1400/10/20
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Actual recruitment end date
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2023-07-23, 1402/05/01
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Trial completion date
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2023-07-23, 1402/05/01
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Scientific title
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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
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Public title
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Movement System Impairment classification approach at knee pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
40
Actual sample size reached:
22
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-07-17, 1400/04/26
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Ethics committee reference number
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IR.IUMS.REC.1400.336
Health conditions studied
1
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Description of health condition studied
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Knee osteoarthritis
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Patellofemoral pain
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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pain intensity
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Timepoint
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over the previous 24 hours and 1 week ago and immediately after the intervention
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Method of measurement
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Visual Analog Scale
2
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Description
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Disability
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Timepoint
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Before and immediately after the intervention
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Method of measurement
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Kujala Questionnaire
Secondary outcomes
1
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Description
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Alignment and movement impairments
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Timepoint
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Before and immediately after the intervention
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Method of measurement
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alignment and movement impairments data form
Intervention groups
1
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Description
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Intervention group: Movement System Impairment based treatment
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Category
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Rehabilitation
2
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Description
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Active control group: routine physiotherapy treatment
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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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
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When the data will become available and for how long
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After completing the present study and publishing the resulting article or articles
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To whom data/document is available
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All researchers in the field of the present study
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Under which criteria data/document could be used
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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
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From where data/document is obtainable
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The corresponding author of the article or articles derived from the study
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What processes are involved for a request to access data/document
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Written request from the author responsible for the present review after the publication of the article or articles
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Comments
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