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IRCT20191213045717N1 IRCT 2020-02-19 Iran University of Medical Sciences Effect of Botulinum Toxin Type A and Methylprednisolone in treatment of Piriformis Syndrome Comparative Trial of Botulinum Toxin Type A and Methylprednisolone for The Treatment of Piriformis Syndrome 2020-02-20 anticipated 30 Complete https://irct.ir/trial/45015 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization, Blinding description: At the begining of the study, all patients in the two groups will be injected in the same place of the body. Post-injection care is the same in all groups. It is worth noting that patients in any of the two groups are not aware of the content of the injections. 3 piriformis muscle syndrome. Intervention 1: Intervention group: 150 U of botulinum toxin type A (Dysport 50-U/ml solution from Daryan Salamat Pharma Group) in 3 ml of normal saline using 22 gauge LP(Lumbar Puncture) needle under ultrasound guidance (lateral approach) will be injected in piriformis muscle. Intervention 2: Control group: 1 cc methylprednisolone (Exir Pharmaceutical Company, made in Iran) &1 cc lidocaine 1% (Aburaihan Pharmaceutical Company, made in Iran) using 22 gauge LP needle under ultrasound guidance (lateral approach) will be injected in piriformis muscle. 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 This will be decided upon completion of the final report.

public Zeynab Shahabi

Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin street, Karim Khane Zand street, Tehran

Tehran Iran (Islamic Republic of) 1593748711 +98 21 8214 1229 zeynab.shahabi@gmail.com Iran University of Medical Sciences scientific Dr Tannaz Ahadi

Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin street, Karim Khane Zand street, Tehran

Tehran Iran (Islamic Republic of) 1593748711 +98 21 8214 1229 tannaz.ahadi@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) The patients age : 20 years or older Screening of patients for clinically significant Lumbar disk herniation or Lumbosacral radiculopathy by Magnetic Resonance Imaging Trigger point and tenderness in their Gluteal area Pain in their buttocks radiating toward their thigh or lower limb and increasing with prolonged sitting and walking and during bending Increased pain through passive forced hip flexion, adduction, and internal rotation (FAIR position), and pain when the leg was flexed at the knee and the hip was passively and medially rotated (Freiberg test) Having pain for more than 3 months despite the conservative treatment and those whose individual minimum pain severity scores will be greater than 5 on a 10-point numeric rating scale (VAS criteria) 20 years no limit Both Known allergy or sensitivity to botulinum toxin type A Previous use of botulinum toxin type A or B Current or planned pregnancy Disorders affecting the Neuromuscular junction or Motor neuron disease,Neurologic deficits found during Electromyelography Administration of Amino- Glycosides or other drugs that interfere with Neuromuscular transmission Previous Micro- surgery or Macro-surgery for disc disease, and any Epidural block within 7 weeks of enrollment S74.0 Injury of sciatic nerve at hip and thigh level Treatment - Other Treatment - Other Intervention group: 150 U of botulinum toxin type A (Dysport 50-U/ml solution from Daryan Salamat Pharma Group) in 3 ml of normal saline using 22 gauge LP(Lumbar Puncture) needle under ultrasound guidance (lateral approach) will be injected in piriformis muscle. Control group: 1 cc methylprednisolone (Exir Pharmaceutical Company, made in Iran) &1 cc lidocaine 1% (Aburaihan Pharmaceutical Company, made in Iran) using 22 gauge LP needle under ultrasound guidance (lateral approach) will be injected in piriformis muscle. The severity of Pain. Timepoint: Before treatment, 1th ,4th,8th &12th weeks after the end of treatment. Method of measurement: Visual Analog Scale (VAS). Quality of life. Timepoint: Before treatment,4th week after the end of treatment. Method of measurement: 36-Item Short Form Health Survey (SF-36). Iran University of Medical Sciences Approved 2019-12-03 Ethics Committee of Iran Universiy of Medical Science Medical School, Iran University of Medical Sciences, Hemmat High way Tehran Tehran Iran (Islamic Republic of)