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IRCT20240317061317N1 IRCT 2024-04-18 Esfahan University of Medical Sciences Investigating the therapeutic effect of laser and shockwave on carpal tunnel syndrome or wrist nerve adhesions CTS/HILT/ESWT Comparative evaluation of high intensity laser & extracorporeal shockwave therapy on pain , symptoms & electrodiagnostic parameters of patients with carpal tunnel syndrome 2024-04-03 anticipated 60 Complete https://irct.ir/trial/76054 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method is used, and sampling will be done by the method of alternating blocks of 2 pieces. In this way, 10 blocks of 3 pieces and each block contains 3 letters from the letters A and B, including AAB-ABA-BBA-BAB-.. . will have. (two groups of 30) each patient is given a card randomly. The cards are in sealed envelopes and the technician takes the envelopes and hands them to the patients, Blinding description: The method of blinding is double-blind, only the first doctor who is responsible for the intervention knows the type of intervention. In order to blind the patient, one main intervention and one other group intervention are performed with the device turned off. Other people involved in the study, including the second doctor who is responsible for conducting the electrodiagnostic test (EMG-NCV), the person responsible for the follow-up of the patients, and the person responsible for analyzing the data are unaware of the placement of the patients in group A or B. N/A Carpal tunnel syndrome. Intervention 1: Intervention group: the group including taking B1 300 drug for one month and wristband for 3 months and performing laser therapy with HILT low fluence protocol (1.6 W- 8 J/cm2) BTL-6000 device, with a combination of wavelength 808 & 1064 nm for 36 seconds and 5 sessions in 2 weeks. Intervention 2: Intervention group: the group including the use of B1 300 drug for one month and wristband for 3 months and performing ESWT shock wave therapy using the radial method and 1000 shock protocol of 0.05 mJ/mm2 and with a frequency of 5 Hz, for this group in three sessions in two week (at least one session per week). 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 There is no further information.
public Hamed zare dehnavi
Hasht Behesht East St., Ahad Alley, Hadith dead end
Esfahan Iran (Islamic Republic of) 8157957764 +98 25 3750 4171 hamdzar29@gmail.com Esfahan University of Medical Sciences scientific babak vahdat pour
Isfahan University of Medical Sciences,Isfahan,Iran
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 9131 vahdatpour@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with mild and moderate idiopathic CTS Age above 18 years and less than 60 years Absence of severe cases (absence of sensory or motor wave in the nerve strip test) Absence of underlying disease such as rheumatoid arthritis Absence of cervical radiculopathy and peripheral polyneuropathy such as diabetes and... 18 years 60 years Both Active hand infection during visit History of injection to treat CTS during the last 3 months Using a heart pacemaker pregnancy Untreated or treated cancer Receiving painkillers and painkillers during the past period G56.0 Carpal tunnel syndrome Treatment - Devices Treatment - Devices Intervention group: the group including taking B1 300 drug for one month and wristband for 3 months and performing laser therapy with HILT low fluence protocol (1.6 W- 8 J/cm2) BTL-6000 device, with a combination of wavelength 808 & 1064 nm for 36 seconds and 5 sessions in 2 weeks. Intervention group: the group including the use of B1 300 drug for one month and wristband for 3 months and performing ESWT shock wave therapy using the radial method and 1000 shock protocol of 0.05 mJ/mm2 and with a frequency of 5 Hz, for this group in three sessions in two week (at least one session per week). The scale of two methods of laser and shock wave therapy on patient's pain. Timepoint: Before the start of the intervention - 4 and 12 weeks after the intervention. Method of measurement: visual analogue scale. Comparison of two methods of laser and shock wave therapy on motor and sensory latency of the distal. Timepoint: Before the start of the intervention - 12 weeks after the intervention. Method of measurement: EMG-NCV. Comparison of laser therapy and shock wave therapy on the severity of symptoms and functional status of carpal tunnel syndrome. Timepoint: Before the intervention - 4 and 12 weeks after the intervention. Method of measurement: Boston questionnaire. Esfahan University of Medical Sciences Approved 2024-03-14 کمیته اخلاق در پژوهش دانشگاه علوم پزشکی اصفهان Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor esfahan Isfehan Iran (Islamic Republic of)