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IRCT20201128049511N3 IRCT 2022-01-14 Tarbiat Modares University Effect of Instrument Assisted Soft Tissue Mobilization on the Muscles around the Knee in People with Knee Osteoarthritis Effect of Instrument-Assisted Soft Tissue Mobilization on Muscular Activity during Walking and Sit to Stand Task in Individuals with Knee Osteoarthritis 2022-01-14 anticipated 34 Complete https://irct.ir/trial/60544 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Individuals are randomly divided into two groups. Therapeutic exercise is common in both groups. The intervention group receives the instrument but the control group receives the instrument as a placebo, Randomization description: Individuals are admitted to the study depending on criteria for inclusion and exclusion. The stratified block randomization approach will be used for this study's randomization. People with moderate osteoarthritis are classified into two subgroups based on the amount of pain (three and four) or (five and six). In each subgroup, randomization is performed by four blocks (two in the treatment group and two in the placebo group). For random allocation, code 1 for treatment and code 0 for placebo are placed in sealed envelopes. In this way, the people of each subgroup take one of the sealed envelope and are assigned in the treatment or placebo group according to the code, Blinding description: Participants will be randomly divided into two groups of treatment and placebo. In the treatment group, the master therapist uses soft tools to treat soft tissue by selecting pressure, direction, type of stroke, distance, duration, speed and type of tool. But in the placebo group, the use of the tool is dramatic and has no therapeutic properties. Both groups receive the same strengthening and stretching exercises so people do not notice this difference. The evaluator is also blind. N/A Knee Osteoarthritis. Intervention 1: Intervention group: A series of lightweight steel instruments are gently applied to the muscles around the knee. The movement of the instrument in specific therapeutic directions is applied to the skin based on the initial assessment, and an emollient is used to move the instrument more easily. The treatment time with this tool is approximately five minutes. Then stretching and strengthening exercises are performed. Intervention 2: Control group: Steel instruments are gently applied to the muscles around the knee in this group. Using an emollient, the instrument is applied as a placebo with the least amount of pressure on the skin in all directions. The tool is moved on the patient's skin in different directions without considering the initial assessment. The direction and pressure applied by the instrument have no therapeutic properties. The treatment time is approximately five minutes. Then stretching and strengthening exercises are performed. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared after people are not identified When: After the results are published, the access phase started six months later To whom: Researchers in academic and research organizations will also have access to the data Conditions: to do scientific research Where to obtain: Sahar Boozari, Jalal Al Ahmad Highway, Tarbiat Modares University s.boozari@modares.ac.ir, 00982182885053 How to obtain: Send the project plan, and if approved, it will be sent following a complete evaluation of the persons and organizations involved in the project Comments:
public Bahare Jafarsalehi
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 5052 b.jafarsalehi@modares.ac.ir Tarbiat Modares University scientific Sahar Boozari
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 5053 s.boozari@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Women and men with osteoarthritis of the knee Ability to walk without the use of assistive devices Pain between three and six in one knee, according to the visual analogue scale A positive clark test result Grade two and three osteoarthritis according to the Kellgren-Lawrence scale 45 years 80 years Both Have a history of a hip or knee joint fracture or ligament injury on the affected side that has resulted in permanent injury Candidate for knee replacement surgery Any congenital disease of the lower extremities or lower back, or any orthopedic, neurological, or rheumatic disease that interferes with a person's normal gait or sit to stand task The difference in the length of the lower limbs is more than one and a half centimeters Body mass index above 30 Genovarum with a knee angle greater than 10 degrees Joint injection in the last six months Medium to high intensity involvement of both knees M17 Osteoarthritis of knee Treatment - Other Placebo Intervention group: A series of lightweight steel instruments are gently applied to the muscles around the knee. The movement of the instrument in specific therapeutic directions is applied to the skin based on the initial assessment, and an emollient is used to move the instrument more easily. The treatment time with this tool is approximately five minutes. Then stretching and strengthening exercises are performed. Control group: Steel instruments are gently applied to the muscles around the knee in this group. Using an emollient, the instrument is applied as a placebo with the least amount of pressure on the skin in all directions. The tool is moved on the patient's skin in different directions without considering the initial assessment. The direction and pressure applied by the instrument have no therapeutic properties. The treatment time is approximately five minutes. Then stretching and strengthening exercises are performed. Muscles activity around the knee joint during walking and sit to stand task. Timepoint: Before and after the Intervention. Method of measurement: Surface electromyography device. Quality of life. Timepoint: Before and after the Intervention. Method of measurement: 36 item short form quality of life questionnaire and lequesne algofunctional index Questionnaire. Pain. Timepoint: Before and after the Intervention. Method of measurement: Pain Visual Analogue Scale. Strength. Timepoint: Before and after the Intervention. Method of measurement: Dynamometer. Tarbiat Modares University Approved 2021-10-27 Ethics committee of Tarbiat Modares University Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)