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IRCT20220504054734N1 IRCT 2022-06-30 Tehran University of Medical Sciences Low-level laser and extracorporeal shockwave in patients with carpal tunnel syndrome The comparison of effectiveness of low-level laser and extracorporeal shockwave in patients with carpal tunnel syndrome 2022-07-21 anticipated 54 Complete https://irct.ir/trial/63381 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Those patients who will meet the study inclusion criteria will be allocated randomly into 3 groups: the control group (routine conservative treatment group), low-level laser therapy group, and extracorporeal shockwave group . A block balanced randomization (1:1:1) with a block size of 6 will be used for random allocation. A random allocation will be performed using the website of www.randomization.com. To conceal the sequence of the random allocation, numbered closed envelopes containing A, B, C groups will be used. Group A will receive the routine conservative treatment, group B will receive low-level laser therapy, and Group C will receive extracorporeal shockwave, Blinding description: In the present study, those who will assess the outcomes and will perform statistical analysis are blinded while the therapist and participants are not blinded. To blind outcome assessor and the person who will perform statistical analysis : no information will be given about type of groups. N/A Carpal tunnel syndrome. Intervention 1: Intervention group: This group will receive Low-level laser , five sessions per week, for two weeks.Each session will last for 5 minutes. Patients will be asked to lay in sitting position and the probe will be hold between the distal crease and kaplan- cardinal line. Intervention 2: Intervention group: This group will receive extracorporeal shockwave two sessions per week, for two weeks. Each session will last for 3-5 minutes. Patients will be asked to lay in sitting position and the probe will be hold on the flexor reticulum of the wrist. Intervention 3: Control group: The control group will receive routine treatments including mobilization, ultrasound (1MHz, 1 W/cm2, for 5 minutes) stretching techniques, hot pack, and TENS (25 minutes) five sessions per week, for two weeks. 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 If the researchers of the secondary studies need to use the IPD, after the publication of the results of the study, the data file will be shared.
public Ali Hossein Ghasemi
School of Rehabilitation of Tehran University of Medical Science; Piche Shemiran; Enghelab street
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7752 8468 ghasemi.amirhossien@yahoo.com Tehran University of Medical Sciences scientific Gholamreza Olyaei
School of rehabilitation of Tehran University of Medical Science; Piche Shemiran; Enghelab street
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7752 8468 olyaeigh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with carpal tunnel syndrome Age between 20 and 60 20 years 60 years Both History of fracture and dislocation in wrist and hand complex during the last 3 months History of surgery in wrist and hand complex during the last 6 months Cervical radiculopathy and thoracic outlet syndrome Pregnancy Receiving coricosteriod injection and physiotherapy treatment during the last 3 months Neurological and systemic diseases, such as rheumatoid arthritis, Parkinson, Multiple Sclerosis G56.0 Carpal tunnel syndrome Rehabilitation Rehabilitation Rehabilitation Intervention group: This group will receive Low-level laser , five sessions per week, for two weeks.Each session will last for 5 minutes. Patients will be asked to lay in sitting position and the probe will be hold between the distal crease and kaplan- cardinal line Intervention group: This group will receive extracorporeal shockwave two sessions per week, for two weeks. Each session will last for 3-5 minutes. Patients will be asked to lay in sitting position and the probe will be hold on the flexor reticulum of the wrist. Control group: The control group will receive routine treatments including mobilization, ultrasound (1MHz, 1 W/cm2, for 5 minutes) stretching techniques, hot pack, and TENS (25 minutes) five sessions per week, for two weeks. Pain. Timepoint: At baseline, after two weeks( the end of the treatment), after a one-week follow-up period. Method of measurement: Visual analog scale. Function. Timepoint: At baseline, after two weeks( the end of the treatment), after a one-week follow-up period. Method of measurement: Boston Carpal Tunnel Syndrome Questionnaire. Grip power. Timepoint: At baseline, after two weeks( the end of the treatment), after a one-week follow-up period. Method of measurement: Dynamometer. Pinch power. Timepoint: At baseline, after two weeks( the end of the treatment), after a one-week follow-up period. Method of measurement: Dynamometer. Amplitude of median sensory nerve. Timepoint: At baseline, after two weeks (the end of the treatment). Method of measurement: Electromyography apparatus. Amplitude of median motor nerve. Timepoint: At baseline, after two weeks (the end of the treatment). Method of measurement: Electromyography apparatus. Latency of median sensory nerve. Timepoint: At baseline, after two weeks (the end of the treatment). Method of measurement: Electromyography apparatus. Latency of median motor nerve. Timepoint: At baseline, after two weeks (the end of the treatment). Method of measurement: Electromyography apparatus. Median nerve conduction velocity. Timepoint: At baseline, after two weeks (the end of the treatment). Method of measurement: Electromyography apparatus. Cross sectional area of median nerve. Timepoint: At baseline, after two weeks (the end of the treatment). Method of measurement: Sonography apparatus. Tehran University of Medical Sciences Approved 2020-10-06 Biomedical Research Ethics Committee of School of Nursing and Midwifery & Rehabilitation of Tehran U Department of research and technology of Tehran University of Medical Sciences; Keshavarz Blvd; Ghods St Tehran Tehran Iran (Islamic Republic of)