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IRCT20221202056684N1 IRCT 2023-01-17 Shahid Beheshti University of Medical Sciences Effect botulinum toxin (type A) in patellofemoral pain syndrome The effect of ultrasound guided intramuscular injection of botulinum toxin (type A) in the distal of the vastus lateralis muscle on pain relief and performance improvement in patients with patellofemoral pain syndrome: A randomized clinical trial 2023-01-05 anticipated 52 Complete https://irct.ir/trial/67167 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In addition to the original interventionو all of the included patients in both groups will be subjected to exercise therapy in the form of stretching of the gastrosoleus muscles, hamstrings, strengthening of the quadriceps muscles and hip adductor muscles for 8 weeks, Randomization description: After signing the consent form to participate in this research, patients will be divided into two groups: A: BoNT-A injection and exercise therapy, and B: Placebo (normal saline) injection and exercise therapy, Blinding description: The present study will be double-blind, so that the patient and the person who compares and records the results of the two groups will be unaware of the type of intervention. To keep them blind, the patients are placed in a lying position and their knees are protected with a cloth, and they will not actually see the injection. 3 Patellofemoral pain syndrome. Intervention 1: Intervention group: each knee will be receiving a total of one vial of 100 units of Botox Allergan (100U/vial) diluted to 10U in 0.1 ml (10 ml in total) in 5 divided doses by injection with ultrasound guidance, in the distal third of the VL muscle. The injections will start from a distance of 3 cm from the upper side of the patella bone and will be injected along a line towards the proximal side of the muscle. The distance between each injection and the next injection will be 2 cm. All injection cases will be given at a fixed time and for all participants in the same period of time, with full compliance with sterile conditions. In addition, each patient in both groups is subjected to exercise therapy in the form of stretching gastrosoleus muscles, hamstrings, strengthening the quadriceps muscles and hip adductor muscles for 8 weeks. Intervention 2: Control group: each of the knees will receive a total of 10 ml of normal saline in 5 divided doses by injection with ultrasound guidance, in the distal third of the VL muscle, starting at a distance of 3 cm from the upper side of the patella and along a line will be injected into the proximal side of the muscle. The distance between each injection and the next injection will be 2 cm. All injection cases will be done in a fixed time and for all participants in the same period of time, with full observance of sterile conditions. In addition, each patient in both groups is subjected to exercise therapy in the form of stretching gastrosoleus muscles, hamstrings, strengthening the quadriceps muscles and hip adductor muscles for 8 weeks. Yes - There is a plan to make this available What will be shared: The collected data, including the background data, and the results investigated in this current study will be published in the form of an Excel file along with the publication of the results and the study protocol in a reputable research journal. When: The data of the study will be accessible from the time of publication of the study by sending an email to the corresponding author of the study To whom: The data of the study will be accessible for the use of researchers by sending an email to the corresponding author of the study Conditions: The use of non-identifiable data of individuals is acceptable for cinducting systematic review and meta-analysis studies Where to obtain: In order to receive the data of this study, by sending an email to the corresponding author of this study, if the conditions required to access the information are met, the data will be provided to the requester. How to obtain: The application should contain information about the applicant, his/her affiliation, phone number, e-mail and the reason for his/her request. If these items are presented and the information related to the applicant's plan is registered and confirmed in the PROSPERO system, the information will be provided to the applicant. Comments:
public Mohammadreza Mashhadi
Orthopedic department, ground floor, 2nd building, Shohada-e-Tajrish hospital, Shahrdari St., Tajrish Sqare
Tehran Iran (Islamic Republic of) 1956815744 +98 21 2228 0182 ahmad_khalili@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammadreza Mashhadi
Orthopedic department, ground floor, 2nd building, Shohada-e-Tajrish hospital, Shahrdari St., Tajrish Sqare
Tehran Iran (Islamic Republic of) 1956815744 +98 21 2228 0182 ahmad_khalili@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients aged 18 to 45 years Clinical diagnosis of PFP syndrome for more than 3 months Pain rating (out of 10) 4 or more Failure to respond to treatment despite receiving at least 8 weeks of non-invasive treatment including exercise therapy, exercise therapy and physical therapy 18 years 45 years Both Presence of knee joint effusion Presence of any evidence in favor of other tibiofemoral pathologies (patellar tendinopathy, presence of evidence of tibiofemoral osteoarthritis or patellofemoral joint space narrowing or arthrosis on radiographs (Kellgren-Lawrence grade II or higher), meniscal tear, knee instability) Evidence in favor of spinal canal stenosis, lumbar radiculopathy, neuropathy and lower limb neuronal damage Any intra-articular injection of the knee in the last 6 months (including hyaluronic acid, ozone or steroids) Body mass index > 35 Previous knee surgery Evidence of injury or inflammatory arthritis of the hip joint Allergy to BoNT-A Pregnancy M22.2X9 Patellofemoral disorders, unspecified knee Treatment - Drugs Treatment - Drugs Intervention group: each knee will be receiving a total of one vial of 100 units of Botox Allergan (100U/vial) diluted to 10U in 0.1 ml (10 ml in total) in 5 divided doses by injection with ultrasound guidance, in the distal third of the VL muscle. The injections will start from a distance of 3 cm from the upper side of the patella bone and will be injected along a line towards the proximal side of the muscle. The distance between each injection and the next injection will be 2 cm. All injection cases will be given at a fixed time and for all participants in the same period of time, with full compliance with sterile conditions. In addition, each patient in both groups is subjected to exercise therapy in the form of stretching gastrosoleus muscles, hamstrings, strengthening the quadriceps muscles and hip adductor muscles for 8 weeks. Control group: each of the knees will receive a total of 10 ml of normal saline in 5 divided doses by injection with ultrasound guidance, in the distal third of the VL muscle, starting at a distance of 3 cm from the upper side of the patella and along a line will be injected into the proximal side of the muscle. The distance between each injection and the next injection will be 2 cm. All injection cases will be done in a fixed time and for all participants in the same period of time, with full observance of sterile conditions. In addition, each patient in both groups is subjected to exercise therapy in the form of stretching gastrosoleus muscles, hamstrings, strengthening the quadriceps muscles and hip adductor muscles for 8 weeks. The amount of pain assessed by Visual Analogue Scale score. Timepoint: The beginning of the study and 2 months after the injection. Method of measurement: Visual Analogue Scale. Examination of knee function using the Anterior Knee Pain Scale. Timepoint: The beginning of the study and 2 months after the injection. Method of measurement: Anterior Knee Pain Scale. Examination of knee function using the Knee injury and Osteoarthritis Outcome Score-Patellofemoral subscale. Timepoint: The beginning of the study and 2 months after the injection. Method of measurement: Knee injury and Osteoarthritis Outcome Score-Patellofemoral subscale. Shahid Beheshti University of Medical Sciences Approved 2022-03-08 Research Ethics Committee of the Faculty of Medicine, Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)