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IRCT20200706048028N1 IRCT 2020-08-24 Babol University of Medical Sciences Comparing the effect of two methods of radial shock wave therapy in patients with carpal tunnel syndrome Comparing the effect of two methods of point and switch radial shock wave therapy on pain intensity and electrophysiological parameters of median nerve in patients with carpal tunnel syndrome 2020-07-29 anticipated 45 Complete https://irct.ir/trial/49490 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are divided into three groups using simple randomization method, Blinding description: The investigators who evaluate the electrodiagnostic and clinical measurements will blind to the allocation and to each other, The patients are blinding too. N/A Mild to moderate Carpal Tunnel Syndrome. Intervention 1: Routine physiotherapy group: Patients in this group receive routine physiotherapy including patient education, TENS, therapeutic ultrasound 3 days a week for 10 sessions and ask them to use short cock-up splint and vitamin B1 300 mg.TENS administer for 20 min each session, at a frequency of 80 HZ, with a pulse duration of 60 µs and at intensity that produce a comfortable tingling sensation. negative electrode is placed on carpal tunnel, and positive electrode is placed on palmar surface of hand.Therapeutic ultrasound administer to the palmar carpal tunnel area for 5 min per session, at a frequency 1 MHZ with intensity of 1 W/cm2 and duty cycle of 50%. we instruct patients to wear the short cock-up splint at night for two weeks and ask them to consumption of vitamin B1 300 mg each day for 4 weeks. Intervention 2: Point shock wave therapy group: patients in this group receive routine physiotherapy including patient education, TENS, therapeutic ultrasound 3 days a week for 10 sessions and ask them to use short cock-up splint and vitamin B1 300 mg exactly similar to routine group, in addition to the aforementioned routine physiotherapy, patient in the point shock wave therapy group receive shock wave therapy for 4 sessions as described below.for shock wave therapy, patients sit in a relax position with their forearm and finger resting on the table. with the palm facing up, the shock wave probe places perpendicularly on patients palm over the median nerve on carpal tunnel after application of the coupling gel. the median nerve is localized by anatomic landmarks on the wrist (scaphoid-pisiform level). shock wave administrate without anesthesia using a pneumatic generator (STORZ Medical Masterpuls MP100, Tagerwilen, switzerland) with 1500 shocks, at a pressure of 1/5 Bar and a rate of 6 pulse per second with point application (hold probe of shock wave stationary over the carpal tunnel). Intervention 3: Switch shock wave therapy group: patients in this group receive routine physiotherapy including patient education, TENS, therapeutic ultrasound 3 days a week for 10 sessions and ask them to use short cock-up splint and vitamin B1 300 mg exactly similar to routine group, in addition to the aforementioned routine physiotherapy, patient in the point shock wave therapy group receive shock wave therapy for 4 sessions as described below.for shock wave therapy, patients sit in a relax position with their forearm and finger resting on the table. with the palm facing up, the shock wave probe places perpendicularly on patients palm over the median nerve on carpal tunnel after application of the coupling gel. the median nerve is localized by anatomic landmarks on the wrist (scaphoid-pisiform level). shock wave administrate without anesthesia using a pneumatic generator (STORZ Medical Masterpuls MP100, Tagerwilen, switzerland) with 1000 shocks, at a pressure of 1/5 Bar and a rate of 6 pulse per second with point application (hold probe of shock wave stationary over the carpal tunnel), and 500 shocks are applied with switch application (switch shock wave’s probe on median nerve pathways on palmar surface of hand). 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 no more information
public Atieh Habibzadeh
Floor1, 5 Bldg, Tohid 16 St, Tohid Cross, Babol , Mazandaran ,Iran
Babol Iran (Islamic Republic of) 66867-47187 +98 11 3233 7101 ati.habibzadeh@yahoo.com Babol University of Medical Sciences scientific Yahya Javadian
Babol university of medical sciences, Ganjafrooz Street , Babol , Mazandaran ,Iran
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3223 8307 javad835@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Patients 20-70 years of age with tingling and numbness or hand pain more than 3 month and confirmed mild to moderate carpal tunnel syndrome by electrophysiological study 20 years 70 years Both G56.00 Carpal tunnel syndrome, unspecified upper limb Rehabilitation Rehabilitation Rehabilitation Routine physiotherapy group: Patients in this group receive routine physiotherapy including patient education, TENS, therapeutic ultrasound 3 days a week for 10 sessions and ask them to use short cock-up splint and vitamin B1 300 mg.TENS administer for 20 min each session, at a frequency of 80 HZ, with a pulse duration of 60 µs and at intensity that produce a comfortable tingling sensation. negative electrode is placed on carpal tunnel, and positive electrode is placed on palmar surface of hand.Therapeutic ultrasound administer to the palmar carpal tunnel area for 5 min per session, at a frequency 1 MHZ with intensity of 1 W/cm2 and duty cycle of 50%. we instruct patients to wear the short cock-up splint at night for two weeks and ask them to consumption of vitamin B1 300 mg each day for 4 weeks. Point shock wave therapy group: patients in this group receive routine physiotherapy including patient education, TENS, therapeutic ultrasound 3 days a week for 10 sessions and ask them to use short cock-up splint and vitamin B1 300 mg exactly similar to routine group, in addition to the aforementioned routine physiotherapy, patient in the point shock wave therapy group receive shock wave therapy for 4 sessions as described below.for shock wave therapy, patients sit in a relax position with their forearm and finger resting on the table. with the palm facing up, the shock wave probe places perpendicularly on patients palm over the median nerve on carpal tunnel after application of the coupling gel. the median nerve is localized by anatomic landmarks on the wrist (scaphoid-pisiform level). shock wave administrate without anesthesia using a pneumatic generator (STORZ Medical Masterpuls MP100, Tagerwilen, switzerland) with 1500 shocks, at a pressure of 1/5 Bar and a rate of 6 pulse per second with point application (hold probe of shock wave stationary over the carpal tunnel). Switch shock wave therapy group: patients in this group receive routine physiotherapy including patient education, TENS, therapeutic ultrasound 3 days a week for 10 sessions and ask them to use short cock-up splint and vitamin B1 300 mg exactly similar to routine group, in addition to the aforementioned routine physiotherapy, patient in the point shock wave therapy group receive shock wave therapy for 4 sessions as described below.for shock wave therapy, patients sit in a relax position with their forearm and finger resting on the table. with the palm facing up, the shock wave probe places perpendicularly on patients palm over the median nerve on carpal tunnel after application of the coupling gel. the median nerve is localized by anatomic landmarks on the wrist (scaphoid-pisiform level). shock wave administrate without anesthesia using a pneumatic generator (STORZ Medical Masterpuls MP100, Tagerwilen, switzerland) with 1000 shocks, at a pressure of 1/5 Bar and a rate of 6 pulse per second with point application (hold probe of shock wave stationary over the carpal tunnel), and 500 shocks are applied with switch application (switch shock wave’s probe on median nerve pathways on palmar surface of hand). Pain intensity. Timepoint: Before intervention, after intervention and 1 month after intervention. Method of measurement: The visual analog scale (VAS) was used to evaluate the degree of pain, which was self assessed by the patients, and the scale ranges from 0 to10. Evaluating symptoms severity and functional status of hand. Timepoint: Before intervention, after intervention and 1 month after intervention. Method of measurement: The Boston questionnaire consists of a symptoms severity scale (SSS) and a functional status scale (FSS), and it was answered by the patients. SSS is evaluated by 11 questions concerning pain, tingling, night symptoms, numbness, and hand weakness and responses range from no symptoms (1point) to symptoms too severe to perform activity (5 point). The average of these 11 scores was used to quantify the severity of patients’ symptoms. FSS consists of 8 questions concerning functional activities and responses range from functional activities with less deficiency (1 point) to functional activities with high deficiency (5 point). The average of these 8 scores was used to quantify the patients’ functional status. Sensory and motor distal latency. Timepoint: Before and after intervention. Method of measurement: EDX evaluating (Nerve Conduction Study). Babol University of Medical Sciences Approved 2020-07-05 Ethics committee of Babol University of Medical Sciences Babol university of medical sciences, Ganjafrooz Street , Babol , Mazandaran ,Iran Babol Mazandaran Iran (Islamic Republic of)