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IRCT20250503065566N1 IRCT 2026-06-13 Tehran University of Medical Sciences effect of botulinum toxin on sensory symptoms in Dialysis patients Evaluation of the effect of botulinum toxin injection in the treatment of neuropathy in ESRD patients 2026-01-21 anticipated 60 Complete https://irct.ir/trial/88314 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The unit of randomization in this study is the individual participant. Participants will be allocated to the study groups using block randomization with a 1:1 allocation ratio. The randomization sequence will be generated by computer using statistical software. The randomization sequence will be prepared by an independent researcher who is not involved in participant recruitment, intervention administration, or outcome assessment, in order to minimize selection bias. To ensure allocation concealment, allocation codes will be kept in sequentially numbered, opaque, sealed envelopes and will be opened only after a participant has been definitively enrolled in the study and according to the predetermined sequence, Blinding description: In this trial, blinding will be implemented for participants, outcome assessors, and data analysts. Participants will not be informed whether they receive botulinum toxin or placebo. In addition, the clinician/researcher responsible for clinical assessments and data collection will remain unaware of group allocation. Preparation of syringes containing botulinum toxin or placebo will be performed by an independent researcher who is not involved in outcome assessment or data analysis. Each syringe will be labeled with a unique code and will be identical in appearance and volume to prevent identification of the assigned intervention. The allocation code list will be kept by the independent researcher and will not be disclosed to the study team until completion of data collection. Statistical analyses will be conducted using group codes, and the codes will be unblinded only after the final analysis is completed. 3 ESRD. Intervention 1: Intervention group: A group of ESRD patients with peripheral neuropathy of the lower limbs who will receive a single session of Dysport Botox injection. The injection dose is 100 units per patient (50 units in the right lower limb and 50 units in the left lower limb), administered subcutaneously in areas with the highest neuropathic symptoms. The injections will be performed by a physical medicine specialist under sterile conditions, and patients will be observed for 30 minutes after injection. Intervention 2: Control group: A group of ESRD patients with peripheral neuropathy of the lower limbs who will receive a normal saline (placebo) injection. The injection will be performed at the same sites and using the same method as the intervention group to ensure identical study conditions. Patients in this group will also be assessed at the same scheduled time points. 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 Results of the study are pending
public Zahra shilan
Tehran, Valiasr Ave., Zarin Alley, Building 16, Apt. 20
Tehran Iran (Islamic Republic of) 1511613745 +98 21 8855 4079 Zahrashilan@gmail.com Tehran University of Medical Sciences scientific Zahra shilan
Tehran, Valiasr Ave., Zarin Alley, Building 16, Apt. 20
Tehran Iran (Islamic Republic of) 1511613745 +98 21 8855 4079 Zahrashilan@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients must have a confirmed diagnosis of ESRD, verified by a nephrology specialist based on clinical and laboratory criteria. Age over 18 years, both genders included. Presence of lower limb peripheral neuropathy symptoms, including pain, burning, numbness, or sensory loss. No botulinum toxin injections or other invasive treatments for neuropathic pain in the past 6 months. At least 3 months since starting renal replacement therapy (RRT). Provided informed consent to participate in the study. 18 years no limit Both History of hypersensitivity or allergic reaction to botulinum toxin. Presence of neuromuscular disorders such as Myasthenia Gravis or Guillain–Barré Syndrome. Presence of uncontrolled systemic diseases such as malignancy, advanced diabetes mellitus or active infection. Pregnancy or breastfeeding at the time of enrollment . History of spinal cord injury, spinal canal stenosis, or cerebrovascular accident (CVA). N18.6 End stage renal disease Treatment - Drugs Placebo Intervention group: A group of ESRD patients with peripheral neuropathy of the lower limbs who will receive a single session of Dysport Botox injection. The injection dose is 100 units per patient (50 units in the right lower limb and 50 units in the left lower limb), administered subcutaneously in areas with the highest neuropathic symptoms. The injections will be performed by a physical medicine specialist under sterile conditions, and patients will be observed for 30 minutes after injection. Control group: A group of ESRD patients with peripheral neuropathy of the lower limbs who will receive a normal saline (placebo) injection. The injection will be performed at the same sites and using the same method as the intervention group to ensure identical study conditions. Patients in this group will also be assessed at the same scheduled time points. Change in mean pain intensity score based on the Visual Analog Scale (VAS) before and after the intervention. Timepoint: Patients will be evaluated at four time points: immediately post-injection, one week, six weeks, and three months post-injection. Method of measurement: Pain intensity will be measured using the Visual Analog Scale (VAS). Patients will record their pain scores at each scheduled time point, and mean scores will be calculated at each time point. Change in mean pain intensity score measured by the McGill Pain Questionnaire (MPQ) before and after the intervention. Timepoint: Patients will be evaluated at four time points: immediately post-injection, one week, six weeks, and three months post-injection. Method of measurement: Pain intensity will be measured using the McGill Pain Questionnaire (MPQ). Patients will record their pain scores at each scheduled time point, and mean scores will be calculated at each time point. Change in mean quality of life score based on the EQ-5D questionnaire before and after the intervention. Timepoint: Patients will be evaluated at four time points: immediately post-injection, one week, six weeks, and three months post-injection. Method of measurement: Patients’ quality of life will be assessed using the EQ-5D questionnaire. Patients will complete the questionnaire at each scheduled time point, and mean scores will be calculated at each time point. Tehran University of Medical Sciences Approved 2024-07-20 Ethics committee of tehran University of Medical Sciences Tehran, Valiasr Ave., Zarin Alley, Building 16, Apt. 20 Tehran Tehran Iran (Islamic Republic of)