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IRCT20220423054620N1 IRCT 2022-06-08 Esfahan University of Medical Sciences Comparison of the effect of high-power and low-power laser and drug therapy in improving the symptoms, function and sonographic findings in patients with carpal tunnel syndrome Evaluation of the comparative effect of high-power and low-power laser and drug therapy in improving the symptoms, function and sonographic findings in patients with mild to moderate carpal tunnel syndrome 2022-06-22 anticipated 66 Complete https://irct.ir/trial/63647 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 66 eligible patients are randomly selected. For this, the letter A is written on 22 sheets, the letter B is written on 22 sheets, and the letter C is written on 22sheets, and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups, Blinding description: In this study, all three groups will be prescribed drug treatment, and in addition, two groups will be under low-power or high-power laser. Due to the difference in the laser power intensity, the Care provider is aware of the type of intervention in each group, but the patient will not be aware of the laser power used. In addition, the investigator, outcome assessor, and data analyzer will not know the type of intervention in the three groups. N/A Carpal tunnel syndrome. Intervention 1: Control group: In this group, patients have routinely prescribed wrist splints, in addition to vitamin B1 and gabapentin 100 mg for two weeks. Intervention 2: Intervention group 1: In this group, patients are prescribed routine treatment including a wrist splint, vitamin B1, and gabapentin 100 mg for two weeks. In addition, patients are treated with a low-power laser (New Vision device) five days a week (for two weeks) with a wavelength of 808 nm and a frequency of 1000 Hz, and an energy of 4 J/cm2 five days a week (for two weeks). The device is placed on the pulse settings and in the area of the carpal tunnel and the palm area in the path of the median nerve branches, the median nerve of fingers 1, 2, 3, and 4 will be fast manual scanning. Intervention 3: Intervention group 2: In this group, patients are prescribed routine treatment including wrist splint, vitamin B1 and gabapentin 100 mg for two weeks. In addition, patients are treated with a high-power laser (Fisioline device) five days a week (for two weeks) with a wavelength of 1064-910 nm and a frequency of 1000 Hz and an energy of 4 J/cm2. The device is placed on the pulse settings and in the area of the carpal tunnel and the palm area in the path of the median nerve branches, the median nerve of fingers 1, 2, 3 and 4 will be fast manual scanning. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Raziye Maghroori
Physical Medicine and Rehabilitation Department, Kashani Hospital, Kashani Street.
Isfahan Iran (Islamic Republic of) 8183983434 +98 31 3233 0091 maghroori@mui.ac.ir Esfahan University of Medical Sciences scientific Raziye Maghroori
Physical Medicine and Rehabilitation Department, Kashani Hospital, Kashani Street.
Isfahan Iran (Islamic Republic of) 8183983434 +98 31 3233 0091 maghroori@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with mild to moderate carpal tunnel syndrome Age category over 18 years No history of injection in the carpal tunnel in a recent month Consent to participate in the study 18 years no limit Both Having neuropathic diseases Having systemic diseases that affect treatment (such as hypothyroidism, diabetes, rheumatism) Having a history of carpal tunnel surgery Pregnancy G56.0 Carpal tunnel syndrome Treatment - Drugs Treatment - Devices Treatment - Devices Control group: In this group, patients have routinely prescribed wrist splints, in addition to vitamin B1 and gabapentin 100 mg for two weeks. Intervention group 1: In this group, patients are prescribed routine treatment including a wrist splint, vitamin B1, and gabapentin 100 mg for two weeks. In addition, patients are treated with a low-power laser (New Vision device) five days a week (for two weeks) with a wavelength of 808 nm and a frequency of 1000 Hz, and an energy of 4 J/cm2 five days a week (for two weeks). The device is placed on the pulse settings and in the area of the carpal tunnel and the palm area in the path of the median nerve branches, the median nerve of fingers 1, 2, 3, and 4 will be fast manual scanning. Intervention group 2: In this group, patients are prescribed routine treatment including wrist splint, vitamin B1 and gabapentin 100 mg for two weeks. In addition, patients are treated with a high-power laser (Fisioline device) five days a week (for two weeks) with a wavelength of 1064-910 nm and a frequency of 1000 Hz and an energy of 4 J/cm2. The device is placed on the pulse settings and in the area of the carpal tunnel and the palm area in the path of the median nerve branches, the median nerve of fingers 1, 2, 3 and 4 will be fast manual scanning. Symptoms. Timepoint: Before treatment, one month and three months after treatment. Method of measurement: Boston Questionnaire. Functional status. Timepoint: Before treatment, one month and three months after treatment. Method of measurement: Boston Questionnaire. Pain. Timepoint: Before treatment, one month and three months after treatment. Method of measurement: Visual Analog Scale (VAS). Nerve Conduction Velocity (NCV) across wrist. Timepoint: Before treatment and three months after treatment. Method of measurement: Nerve and muscle strip. Sensory nerve action potential (SNAP) across wrist. Timepoint: Before treatment and three months after treatment. Method of measurement: Nerve and muscle strip. Compound Muscle Action Potential (CMAP) across wrist. Timepoint: Before treatment and three months after treatment. Method of measurement: Nerve and muscle strip. Cross-sectional area (CSA) carpal tunnel. Timepoint: Before treatment and three months after treatment. Method of measurement: Sonography. Isfahan University of Medical Sciences Approved 2022-02-13 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)