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IRCT20250220064788N1 IRCT 2025-05-29 Tehran University of Medical Sciences Effectiveness of Botox injection on chronic Plantar fasciitis Effectiveness of Botulinium toxin A administration to Gastrecnemius muscle on pain and function among patients with chronic plantar fascitiis, Randomized control double blinded study 2025-05-22 anticipated 42 Complete https://irct.ir/trial/82042 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, Block randomization is used. 42 participants in this research will be placed in six blocks of seven randomly. Allocation of each participant to intervention and control groups based on randomization was done by a person other than the researcher (a third party) and a syringe with unknown content for the researcher and volunteer was given to the researcher for injection by a third party. The information related to the contents of the syringes used by each volunteer will remain in the possession of a third party until the final analysis of the information, and the researcher and the volunteers will not be aware of this information, Blinding description: The appearance of the syringes of the intervention and control groups is completely the same and only the contents of the syringes are different from each other. The preparation and delivery of the syringes to the researcher before each stage of the study will be done by a third party based on randomization blocks. Only the third party will be aware of the contents of the delivered syringes (neither the researcher nor the volunteers will be informed) and the researcher will not be aware of the content of the injected syringes for each volunteer until the final analysis of the data. The final analysis of the data will be done by the researcher. 3 Plantar fascial fibromatosis. Intervention 1: Intervention group:In the intervention group, 70 units of Botulinum Toxin A are injected into the upper third of the medial head of the gastrocnemius muscle. The drug, produced by the 500-unit Masport company, is diluted with 2.5 cc of normal saline for injection. Subsequently, a stretching exercise program for the lower limb is prescribed for 8 weeks. Intervention 2: Control group:In the control group, the same volume of normal saline is injected, and a similar 8-week exercise program is prescribed as in the intervention group. Yes - There is a plan to make this available What will be shared: The present research has been registered as a proposal for the thesis of the Sports Medicine Residency Program. The resulting thesis from this proposal, including all participant data, study protocol, statistical analyses, and the full study report encompassing all variables, will be submitted to Tehran University of Medical Sciences and the Department of Sports Medicine. It is noteworthy that, upon approval of the thesis, an article containing all the mentioned elements will be published in a journal relevant to the topic of the research. Please note that access to raw data not included in the final report or published article requires direct communication with the principal investigator of the study When: A period of two years has been estimated for all stages of the study until its submission as a thesis. The data obtained from this research will be submitted for publication as an article after the thesis has been approved at the end of the two-year period. Access to the raw data not included in the final report or the published article will be possible after the article's publication through direct communication with the principal investigator of the study. To whom: The data obtained from this research will be available to all interested individuals, and there will be no restrictions on access. Conditions: There are no restrictions on the use, publication, or further processing of the data from this study, provided that prior communication is established with the principal investigator via email or other means, and the necessary permission is granted by the principal investigator. Where to obtain: To access the information of this study, the interested individual may contact the principal investigator via email or phone. How to obtain: The permission to use the information will be granted to the interested individual as soon as the email is received or the phone contact is made, and the requested information will be promptly sent to the individual via email. Comments:
public Declaration salehifar
Imam khomeini Ave
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 Delaraa.salehifar@gmail.com Tehran University of Medical Sciences scientific Margam Abolhasani
Imam khomeini Ave
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 dr_m_abolhasani@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) People with a clinical diagnosis of chronic plantar fasciitis who have received supportive treatment for at least 2 months and have not responded to the treatment Presence of pain in the heel for at least two months with a VAS between numbers 3 and 7 (out of 10) at the time of examination 18 years 65 years Both Suffering from a significant physical and mental illness that increases the risk of disrupting the study process Drug or Substance addiction Pregnancy or breastfeeding The presence of injury in the studied lower limb A history of Corticosteroid or PRP injection in the plantar fascia during at least the last 6 months History of Neuromuscular diseases such as Myasthenia gravis Allergy to botulinum toxin or eggs Suffering from orthopedic and medical problems that are contrary to the possibility of the person's participation in the study Heel pain with diagnoses other than plantar fasciitis The use of foot Orthoses since the time of entering the study Use of NSAID with anti-inflammatory dose during the study M72.2 Plantar fascial fibromatosis Treatment - Drugs Placebo Intervention group:In the intervention group, 70 units of Botulinum Toxin A are injected into the upper third of the medial head of the gastrocnemius muscle. The drug, produced by the 500-unit Masport company, is diluted with 2.5 cc of normal saline for injection. Subsequently, a stretching exercise program for the lower limb is prescribed for 8 weeks. Control group:In the control group, the same volume of normal saline is injected, and a similar 8-week exercise program is prescribed as in the intervention group. Tenderness using VAS (Visual Analog Scale). Timepoint: Before injection and after eight weeks. Method of measurement: A 10-mm line will be drawn on paper, marked with '0' at one end and '10' at the other. Participants will be asked to indicate their overall pain level by marking a point on the line. FAAM questionnaire. Timepoint: Before injection and after eight weeks. Method of measurement: Responses to the questionnaire and the total scores of the daily activities and sports subscales will be recorded. Tehran University of Medical Sciences Approved 2024-05-02 Research Ethics Committees of SINA Hospital- Tehran University of Medical Sciences Imam khomeini avenue Tehran Tehran Iran (Islamic Republic of)