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IRCT20180627040251N5 IRCT 2023-03-30 Kharazmi University Comparison between MSI and routine physiotherapy treatments in knee pain patients The comparison of treatment using Movement System Impairment method with routine physical therapy in improving pain and function in patents with knee pain: A randomized clinical trial 2023-03-28 anticipated 40 Complete https://irct.ir/trial/66428 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomized into intervention and one control group using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope, Blinding description: The patients are aware of the study, but they are not aware of each exercise in each method and only perform each given exercise. Then the patients are evaluated by an examiner while another person teaches the exercises to patients. At the end of study, the patients are again assessed by the same examiner while the examiner is not aware of patient's grouping. Furthermore, the statistician analyzes the data who is not aware of each treatment group's conditions. N/A Condition 1: Knee pain. Condition 2: Chronic pain. Intervention 1: Intervention group: This group consists of patients with knee pain that are treatable with physiotherapy after initial assessment. In this group, patients are classified based on “Movement System Impairments “ (MSI) method. In this system of classification of patients, they are categorized in one of the MSI groups based on the signs and symptoms consisting of pain (primary variable) and function (secondary variable) in different positions (secondary variable). Since each group has a different characteristic in comparison to others, patients are treated based on the group they are categorized in. Treatment consists of strengthening each category. These exercises are prescribed based on the problem in each group. Moreover, the patient will be taught what to be cautious about, what to avoid, and what needs to be done in daily tasks. If there is a desire for the taping of the patellar bone to correct the patellar alignment through the treatment, it will be done, as well. Stretching exercises are another part of the exercises that might be prescribed based on necessity. These exercises are performed for 6 weeks. Intervention 2: Control group: This group consists of patients with knee pain that have been diagnosed as treatable by physiotherapy while they are not categorized in specific groups. Their treatment is based on routine physiotherapy exercises. The term routine physiotherapy consists of training knee pain through muscle strengthening exercises, stretching, and teaching the positions that the patient should avoid without being in a specific group. All these treatments are taught to all patients. These exercises continue for 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not necessary to publish this information
public Dr. Hassan Sadeghi
3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,
Tehran Iran (Islamic Republic of) 33111-15447 +98 21 2222 8001 Hassan.sadeghi81@yahoo.com Kharazmi University scientific Mohammadreza Farazdaghi
Chamran Blvd.-Abiverdi Ave.
Shiraz Iran (Islamic Republic of) 71345-1733 +98 71 3627 1552 mfarazdagh@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Knee pain at least 2 months before examination Pain between 30-70 based on "Numeral Rating Scale" 18 years 65 years Both The confirmation of the need for surgery Systematic, Metabolic or Neurologic disease (such as radiculopathy) Pregnancy The need for analgesic or anti-inflammatory drugs during the treatment period M25.56 G89.4 Pain in knee Chronic pain syndrome Rehabilitation Rehabilitation Intervention group: This group consists of patients with knee pain that are treatable with physiotherapy after initial assessment. In this group, patients are classified based on “Movement System Impairments “ (MSI) method. In this system of classification of patients, they are categorized in one of the MSI groups based on the signs and symptoms consisting of pain (primary variable) and function (secondary variable) in different positions (secondary variable). Since each group has a different characteristic in comparison to others, patients are treated based on the group they are categorized in. Treatment consists of strengthening each category. These exercises are prescribed based on the problem in each group. Moreover, the patient will be taught what to be cautious about, what to avoid, and what needs to be done in daily tasks. If there is a desire for the taping of the patellar bone to correct the patellar alignment through the treatment, it will be done, as well. Stretching exercises are another part of the exercises that might be prescribed based on necessity. These exercises are performed for 6 weeks. Control group: This group consists of patients with knee pain that have been diagnosed as treatable by physiotherapy while they are not categorized in specific groups. Their treatment is based on routine physiotherapy exercises. The term routine physiotherapy consists of training knee pain through muscle strengthening exercises, stretching, and teaching the positions that the patient should avoid without being in a specific group. All these treatments are taught to all patients. These exercises continue for 6 weeks. 1) Pain score based on Numeral Rating Scale of 0-100. 100 shows the worst pain and 0 is the least amount of pain. Timepoint: At the start of the study (Before intervention) and 6 weeks after the start of the study (End of study). Method of measurement: Pain is evaluated by marking on a line which is divided to 100 points. Knee alignment. Timepoint: At the start of the study (Before intervention) and 6 weeks after the start of the study (End of study). Method of measurement: Knee alignment is measured in standing, sitting, walking, standing on one leg, and stairs position. Function based on questionnaire of Knee injury and Osteoarthritis Outcome Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. Timepoint: At the start of the study (Before intervention) and 6 weeks after the start of the study (End of study). Method of measurement: The function is measured by Knee injury and Osteoarthritis Outcome Score questionnaire. Kharazmi University Approved 2022-08-22 Sport Sciences Research Institute (SSRI) No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)