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IRCT20190428043404N1 IRCT 2019-12-25 Iran University of Medical Sciences Comparison of corticosteroid with botulinum toxin in treatment of chronic calcaneal spur PF Clinical trial comparison of ultrasound guided local injection of botulinum toxin type A with corticosteroid in treatment of chronic plantar fasciitis 2020-01-01 anticipated 40 Complete https://irct.ir/trial/42435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization, Blinding description: patients are randomly divided into 2 groups in closed packing. 2-3 plantar fascial fibromatosis. Intervention 1: Intervention group: will receive ultrasound guided localized injection of 150 unit botulinum toxin type A in the foot intrinsic muscles. Intervention 2: Control group:will receive ultrasound guided localized injection of 1 cc methylprednisolone and 1 cc normal saline 0.9% in the attachment of the plantar fascia to the calcaneal bone. Yes - There is a plan to make this available What will be shared: The study will be published in an article When: Just after publication To whom: researchers Conditions: for research purpose Where to obtain: from the indexing journal website How to obtain: the researcher must download the article Comments:
public Sasan Sadeghi Nik
Firoozgar hospital;Beh Afarin St;Vali asr SQ;Tehran
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8214 1229 sasansadeghinik444@gmail.com Iran University of Medical Sciences scientific Gholamreza Raissi
Firoozgar Hospital;Beh Afarin St;Valiasr SQ;Tehran;Iran
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8893 7902 graissi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) history of plantar fasciitis,patients suffering from heel pain with a VAS more than 4 months for at leate two month whose history physical exam and sonography confirmed plantar fasciitis 18 years 75 years Both History of direct trauma other causes of heel pain( fracture,tumor,infection,nerve entrapement) systemic inflammatory or soft tissue disease disk herniation with S1 radiculopathy poor controlled diabetes history of gout association with other causes of foot pain(severe osteoarthritis,morton neuroma,matatarsalgia) surgery or injection in fascia since 6 month ago coagulopathy pregnancy hypersensitivity to corticosteriod or botulinum toxin or lidocain antibody against botulinum toxin any treatment for the condition since 4 weeks ago anti inflammatory drugs,physiotherapy,splint, iontophoresis, phonophoresis and shock wave in the last 3 month M72.2 Plantar fascial fibromatosis Treatment - Drugs Treatment - Drugs Intervention group: will receive ultrasound guided localized injection of 150 unit botulinum toxin type A in the foot intrinsic muscles. Control group:will receive ultrasound guided localized injection of 1 cc methylprednisolone and 1 cc normal saline 0.9% in the attachment of the plantar fascia to the calcaneal bone Pain intensity at the standing position. Timepoint: All the outcomes were evaluated at the baseline visit,1 month and 3 months after the intervention. Method of measurement: Visual analog scale. Early morning pain,pain on joint movement,daily activities,climbing stairs and exercise tolerance. Timepoint: All the outcomes were evaluated at the baseline visit,1 month and 3 months after the intervention. Method of measurement: Visual analog scale.we also assess the ability to perform daily activities,climbing stairs and exercise tolerance with FAAM questionnaire. Iran University of Medical Sciences Approved 2018-12-04 Ethics committee of Iran University of Medical Sciences (IUMS) Iran university of Medical Sciences,Hemmat highway,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)