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IRCT20210526051412N1 IRCT 2021-06-05 Tehran University of Medical Sciences The comparison of clinical outcome of early motion versus late motion following arthroscopic repair of rotator cuff tearing; Randomized Clinical Trial Study The comparison of clinical outcome of early motion versus late motion following arthroscopic repair of rotator cuff tearing; Randomized Clinical Trial Study 2021-06-22 anticipated 30 Complete https://irct.ir/trial/56571 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the restricted randomization method randomization (block randomization type randomization (we will use. blocking usually in order Balance the number of samples assigned to each group To be used in the study. This feature helps researchers to Items that require intermediate analyzes during the sampling process The number of samples assigned to each of the case groups The study is equal. The size of all the blocks is equal and we are in this Two-group trial of 6 blocks (including 3 participants in We will have an intervention group and 3 participants in the control group. Randomization tools are also used in sequence generation software Random (software allocation Random) is used that Random sequence generation software in addition to simple randomization capable To produce random sequences by block generation method. For hiding We avoid concealment allocation We use the method used to execute the sequence Random refers to study participants, in a way That before the individual is assigned, the assigned group is not specified. With From opaque envelopes sealed in random sequence (envelopes opaque, sealed, numbered Sequentially ) This method uses each of the random sequences created on a card It is registered and the cards are placed in the letter envelopes in order To be. In order to maintain a random sequence, also on the outer surface of the envelope The numbering is done in the same way. Finally the envelope door The letters are pasted and placed in a box, respectively. At Time to start registration of participants, based on the order of entry of the company Eligible applicants to open one of the envelopes in order And the assigned group of the participant will be revealed, Blinding description: The study will be blinded one way. Patients according to type Interventions will not be blinded. The researcher must enter the data into the checklist The corresponding slow will be blinded to the type of intervention. The person in charge of the clinical care of the patients, as well as the physiotherapist, will not be blinded. N/A Arthropocytic treatment of rotator cuff tear. Intervention 1: Intervention group: Physiotherapy is performed immediately after arthroscopic repair surgery, ie from the day after the operation. The duration of each session is 30 minutes and 3 sessions per week and the total number of sessions is 30 sessions. TENS, IR, EXE, US modals will be used equally in all patients. All patients with inactive shoulder movements will start from the first session. . All patients will receive physiotherapy at a center by a physiotherapist. Intervention 2: Control group: Shoulder physiotherapy 4 weeks after arthroscopic repair surgery begins as 3 sessions of shoulder physiotherapy per week with 30 sessions with the emphasis on passive movements and performing tens and exercise and ultrasound and IR. Yes - There is a plan to make this available What will be shared: In this section, patient information such as age, sex, and body mass index are published publicly, but patient names are not published. When: After confirming the ERCT code, we will start the study and 8 months later the data will be available to the public To whom: It will be available only to researchers working in academic and scientific institutions Conditions: We will make the data available to reputable scientific journals or orthopedic field research researchers in an unidentifiable individual manner. Where to obtain: 1- Email correctly to sadulasharifpour@gmail.com 2- Call the mobile number 09214736009 How to obtain: The applicant will be provided with the identity of the applicant within one week after the initial request Comments:
public Sadula Sharifpour
Office of the Director of the Orthopedic Department. Imam Khomeini Hospital Complex. End of Keshavarz Boulevard.
Tehran Iran (Islamic Republic of) 1418813675 +98 21 6643 5786 sadulasharifpour@gmail.com Tehran University of Medical Sciences scientific Nima Bagheri
Sabet Street
Tehran Iran (Islamic Republic of) 1418813675 +98 21 6643 5786 nimab1360@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with full-thickness rotator cuff rupture diagnosed by MRI include patients with acute rupture or chronic rupture Ruptures involving only the supraspinatus on a grade 1 or grade 2 coronary MR 18 years 70 years Both 1 - Age under 18 years 2 - Other diseases of the shoulder joint such as infection, avascular necrosis and so on Major medical disease that makes it unlikely to live under 2 years 4. A specific psychiatric illness that impairs the possibility of conscious satisfaction .5 - Inability to speak or read Persian 6 - Large ruptures or massive rotator cuff with extension to the subscapularis and minor fear 7 - Simultaneous pathology in labrum that requires surgery 8 - Simultaneous pathology in the acromioclavicular joint that requires distal clavicle resection. 9- Age over 70 years M75.1 Rotator cuff tear or rupture, not specified as traumatic Rehabilitation Rehabilitation Intervention group: Physiotherapy is performed immediately after arthroscopic repair surgery, ie from the day after the operation. The duration of each session is 30 minutes and 3 sessions per week and the total number of sessions is 30 sessions. TENS, IR, EXE, US modals will be used equally in all patients. All patients with inactive shoulder movements will start from the first session. . All patients will receive physiotherapy at a center by a physiotherapist. Control group: Shoulder physiotherapy 4 weeks after arthroscopic repair surgery begins as 3 sessions of shoulder physiotherapy per week with 30 sessions with the emphasis on passive movements and performing tens and exercise and ultrasound and IR. In this study, we want to compare the amount of shoulder forward flexion based on the physiotherapy group immediately and the physiotherapy group 4 weeks later. Timepoint: It is at intervals of 3, 6 weeks, 3, and 6 months after rotator cuff arthroscopic repair. weeks, 3 months, and six months. will be measured. Method of measurement: With a questionnaire and through the scoring system is the Constant Murley scoring system, which scores between zero and one hundred. Ultrasound 6 after arthroscopic repair of rotator cuff tearing. Timepoint: 6 months after surgery. Method of measurement: By sonography and according to the criteria of Sugaya and radiologist. Vice Chancellor for Research and Technology, Tehran University of Medical Sciences Approved 2020-09-01 Ethics committee of Tehran University of Medical Sciences Tehran, Keshavarz Blvd., Imam Khomeini Hospital tehran Tehran Iran (Islamic Republic of)