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IRCT20191027045252N1 IRCT 2020-01-10 Iran University of Medical Sciences Comparison of the efficacy of in vivo shock therapy with corticosteroid injection in the treatment of piriformis syndrome Comparison of the efectiveness of Radial Extracorporeal Shock wave Therapy and corticosteroid injection of piriformis muscle for treatment patients suffering of piriformis syndrome 2019-12-22 anticipated 35 Complete https://irct.ir/trial/43295 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, in which each member of society has an equal and independent chance of being elected. The randomization procedure will use a randomized block with quadratic and binary blocks. Given the sample size of 35 people, 8 quadruple blocks and 1 binary blocks will be generated and numbered using the permutations method. Using the random number table, blocks will be placed together to form a sequence of patients assigned to treatment groups. Therefore, prior to selecting the participants, the type of treatment they receive will be unaware, and the random sequence generated during the study will be unpredictable, Blinding description: Due to the difference in the nature of the therapeutic intervention in the two groups, only the data analyzer will be blind. 3 Piriformis syndrome. Intervention 1: Intervention group: Patients undergoing shockwave therapy, three sessions, each lasting 7 to 10 days. Shockwave is performed with the Storz Medical Shock Wave MP100. Each session of shockwave therapy with 2000 pulses and a total of 6000 pulses in three sessions, energy flux density equal to 0.18 mJ / mm², 5 Hz frequency, 4 bar pressure rate, Dose per treatment equal to 0.18 mJ / mm2 = 2,000 360 mJ / mm2 and Total energy dose (TED) equal to 1.080 J / mm2. Intervention 2: Control group: Patients treated with 40 mg methylprednisolone plus 1 cc lidocaine 1% undergo sonography in the piriformis muscle. Yes - There is a plan to make this available What will be shared: The extent of pain relief can be shared according to the Visual Analogue Scale. When: Access started from 1400 To whom: Study data will be available only to researchers working in academic and scientific institutions. Conditions: Access to the data will be allowed for epidemiological study and can be sent by email. Where to obtain: To receive data, you could call 00989123190373 or contact arastoo.yousefi@gmail.com. How to obtain: Individuals who request data, must provide their academic, Scientific documents and the reason for their requests to arastoo.yousefi@gmail.com. Comments:
public Arash Babaei
No 4, Banafshe Deadend, Second Deadend, Hoseini Ave, North Shahrdari, West Sarv Blvd, Saadat Abad, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2235 9437 arastoo.yousefi@gmail.com Iran University of Medical Sciences scientific Arash Babaei
No 4, Banafshe Deadend, Second Deadend, Hoseini Ave, North Shahrdari, West Sarv Blvd, Saadat Abad, Tehran
Tehran Iran (Islamic Republic of) 1998774714 +98 21 2235 9437 arastoo.yousefi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Chronic pain in Batuk, thigh and lower extremity for at least 3 months Patients must be over 20 years of age Screening of all patients for lumbar disc herniation and lumbar radiculopathy by MRI. Their pain intensity should be at least 5 out of 10 according to the Visual Analogue Scale criteria 20 years no limit Both Symptoms of lumbar discus, coxopathy, mechanical or inflammatory disorders of the sacroiliac joint Any inflammatory, infectious, or pelvic abnormalities Have a pregnancy or pregnancy plan Have a history of disc surgery and any epidural block over the past 6 months. Patients who do not go for follow-up for any reason. Changes in the patient's treatment according to the physician's opinion or other treatment by the patient during the study G57.0 Lesion of sciatic nerve Treatment - Devices Treatment - Drugs Intervention group: Patients undergoing shockwave therapy, three sessions, each lasting 7 to 10 days. Shockwave is performed with the Storz Medical Shock Wave MP100. Each session of shockwave therapy with 2000 pulses and a total of 6000 pulses in three sessions, energy flux density equal to 0.18 mJ / mm², 5 Hz frequency, 4 bar pressure rate, Dose per treatment equal to 0.18 mJ / mm2 = 2,000 360 mJ / mm2 and Total energy dose (TED) equal to 1.080 J / mm2. Control group: Patients treated with 40 mg methylprednisolone plus 1 cc lidocaine 1% undergo sonography in the piriformis muscle. Severity of pain. Timepoint: Baseline, 7, 30, 60, and 90 days after Intervention. Method of measurement: Visual Analogue Scale. Quality of Life. Timepoint: Baseline and 30 days after Intervention. Method of measurement: 36-Item Short Form Survey (SF-36) questionnaire. Iran University of Medical Sciences Approved 2019-09-23 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)