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IRCT20220723055523N1 IRCT 2022-08-16 Qazvin University of Medical Sciences Evaluation of the repair process of thumb flexor tendons after Botox injection in the thumb flexor muscles Evaluation of the repair process of thumb flexor tendons after Botox injection in the thumb flexor muscles 2023-02-20 anticipated 100 Complete https://irct.ir/trial/65050 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned randomly in a double-blind manner in the control or intervention groups based on the Balanced Block Randomization method into two groups A and B in blocks AABB-BBAA- ABAB-BABA-ABBA-BAAB which are 4 blocks, Blinding description: This is a double-blind type of experiment that will be blind for the people participating in the study. In the consent form to participate in the study, it is written for the patient that his presence does not necessarily mean intervention but may be included in the control group. The main investigator of the study in this trial will not be blind because he will be the final evaluator of the results between the two groups. Since the writing of the article will be done by the main researcher, who is responsible for the project and the analysis of the results at the end, blinding will not be done for him. In addition, considering that this is a study that takes place during hand tendon surgery, it is practically not possible to keep the intervention blind for the surgeon, although the nurses and especially the physiotherapist will be blind to the intervention. 3 Thumb flexor tendon injury. Intervention 1: Control group: after the surgery, casting is done for 4 weeks, after removing the cast, active movements and physiotherapy are done for 3 months in the control group. Intervention 2: Intervention group: One hour before the start of the reconstructive surgery, between 50 and 100 units of botulism toxin along with 10 ml of normal saline are injected into the flexor pollicis longus (FDL) muscle. Injected botulism is produced by Diston brand of Imen Vaccine pharmaceutical company.After surgery, intervention group is casted for 4 weeks. After removing the cast, active movements and physiotherapy are done for 3 months in intervention group. Yes - There is a plan to make this available What will be shared: all variables and total potential data can be shared after people are identifiable When: start access period 6 months after printing results To whom: It will be available to researchers working in academic institutions. Conditions: The data can be reviewed and used to improve clinical conditions and maintain patient health and perform meta-analyzes. Where to obtain: They can request the author's email or from the research center or university. How to obtain: Apply by email or post to Qazvin University of Medical Sciences. Comments:
public Behzad Afzali
Shahid Safdari Alley, Padegan Ave, QAzvin
Qazvin Iran (Islamic Republic of) 3413996134 +98 28 3333 5800 drbehzadaf@gmail.com Qazvin University of Medical Sciences scientific Mohammad Soroush
Shahid Safdari Alley, Padegan Ave, QAzvin
Qazvin Iran (Islamic Republic of) 3413996134 +98 28 3333 5800 m.sorosh@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients aged 15 to 50 who have acute damage to the deep flexor tendons of the thumb and refer to the surgical clinic of Shahid Rajaei Hospital in Qazvin. Provide written consent to enter the study 15 years 50 years Both Patients who have simultaneous damage to hand extensor tendons. Patients who have simultaneous damage in two flexor levels of the hand. Patients who have simultaneous bone fractures in the affected limb. Patients who have simultaneous nerve damage in the affected limb. M66.3 Spontaneous rupture of flexor tendons Treatment - Surgery Treatment - Surgery Control group: after the surgery, casting is done for 4 weeks, after removing the cast, active movements and physiotherapy are done for 3 months in the control group. Intervention group: One hour before the start of the reconstructive surgery, between 50 and 100 units of botulism toxin along with 10 ml of normal saline are injected into the flexor pollicis longus (FDL) muscle. Injected botulism is produced by Diston brand of Imen Vaccine pharmaceutical company.After surgery, intervention group is casted for 4 weeks. After removing the cast, active movements and physiotherapy are done for 3 months in intervention group. Evaluation of joint movement limitation in each group. Timepoint: 3 months after surgery. Method of measurement: Buck-Gramcko method. Evaluation of tendon re-rupture. Timepoint: 3 months after surgery. Method of measurement: Magnetic resonance imaging (MRI). Evaluation of the side-effects of Botulism injection. Timepoint: 3 months after surgery. Method of measurement: Asking patients and evaluating its performance by the surgeon. Qazvin University of Medical Sciences Approved 2021-07-18 Ethics Committee of Qazvin University of Medical Sciences Maveddat Alley, Shahid Beheshti Blvd, Qazvin Qazvin Qazvin Iran (Islamic Republic of)