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IRCT20200825048515N41 IRCT 2021-09-27 Esfahan University of Medical Sciences Evaluation of the effect of extracorporeal shockwave therapy after botulinum toxin injection on cuff muscle spasticity improvement Evaluation of the effect of extracorporeal shockwave therapy after botulinum toxin injection on cuff muscle spasticity improvement in patients with multiple sclerosis 2021-09-23 anticipated 20 Complete https://irct.ir/trial/58566 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, eligible patients will likely be selected sequentially. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups, Blinding description: Due to the nature of the current study, the researcher is aware of the type of intervention in each of the two groups, but the patient and the evaluator (data collector) are not aware of the type of surgery in each group. 2-3 Multiple sclerosis. Intervention 1: Control group: In this group, only botulinum toxin injection with BTX-A was performed for the patient under the standard protocol, for this purpose, 100-200 mU of Botox type A, Dysport is used. This injection is performed in the medial and lateral heads of the cuff muscle based on the severity of the spasticity. Intervention 2: Intervention group: In this group, after injection of botulinum toxin with BTX-A according to the standard protocol, it is treated with extracorporeal shock wave therapy. For this purpose, radial energy is used with an intensity of 4 times and the its frequency is 8 Hz. The number of shocks is 2000 shocks on the gastrocnemius muscles, 600 shocks on the soleus muscle and 200 shocks on the Achilles tendon. The number of sessions is 5 sessions once a week. The device used for ESWT is Nortz Medical- Duolith SD1. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Shila Haghighat
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Haghighatshila@gmail.com Esfahan University of Medical Sciences scientific Shila Haghighat
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Haghighatshila@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Definitive diagnosis of multiple sclerosis based on the opinion of a neurologist Presence of spasticity in the cuff muscles (based on a score of more than 1 on the modified Ashworth scale (MAS) consent to participate in the study no limit no limit Both Having cognitive disorders (in advanced stages of the disease) Having myopathy or peripheral nerve disease Having a pace maker Pregnancy Pre-injection of botulinum toxin during the last 6 months Having cuff muscle atrophy Having coagulation disorders History of previous surgery or fracture at the site of spastic muscles G35 Multiple sclerosis Treatment - Drugs Other Control group: In this group, only botulinum toxin injection with BTX-A was performed for the patient under the standard protocol, for this purpose, 100-200 mU of Botox type A, Dysport is used. This injection is performed in the medial and lateral heads of the cuff muscle based on the severity of the spasticity. Intervention group: In this group, after injection of botulinum toxin with BTX-A according to the standard protocol, it is treated with extracorporeal shock wave therapy. For this purpose, radial energy is used with an intensity of 4 times and the its frequency is 8 Hz. The number of shocks is 2000 shocks on the gastrocnemius muscles, 600 shocks on the soleus muscle and 200 shocks on the Achilles tendon. The number of sessions is 5 sessions once a week. The device used for ESWT is Nortz Medical- Duolith SD1. Pain. Timepoint: Before, immediately, 2 weeks and 8 weeks after the intervention. Method of measurement: Visual Analogue Scale (VAS). Spasticity score. Timepoint: Before, immediately, 2 weeks, and 8 weeks after the intervention. Method of measurement: Modified Ashworth's Scale (MAS). Isfahan University of Medical Sciences Approved 2019-10-09 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)