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IRCT20190428043404N2 IRCT 2023-04-23 Iran University of Medical Sciences Evaluation of Clemastine effects in CTS pateints Evaluation of Clemastine effects on clinical and electrodiagnostic parameters in Carpal tunnel syndrome (CTS) patients: A double blind RCT 2023-05-22 anticipated 20 Complete https://irct.ir/trial/69477 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to case and control groups based on computer randomization. The group matching method will be used to control confounding variables (age and gender, body mass index) in two groups. Also, for the purpose of allocation concealment, the assignment of patients to two control and sample groups will be done randomly by someone other than the researcher, and until after the end of the treatment and the analysis, the patient and the therapist will not know the type of treatment (drugs or placebo), Blinding description: Regarding the double-blindness of this study, it should be noted that all patients receive apparently similar treatment (completely identical appearance and prescription for placebo and drug) and despite the patient's knowledge of the study and the possibility of receiving a placebo, being in the control group or the sample group will not be known to patients. In order to blind the Assessor, the therapist and the main analyst will not know about the group assigned to each patient, and the delivery of the drug or placebo to the patient will be the responsibility of another person. 2-3 Carpal tunnel syndrome. Intervention 1: Intervention group: 1 mg clemastine tablet every night along with CTS night splint (Volar cockup wrist splint, Prefabricated) for three months. Intervention 2: Control group: Taking a placebo tablet without active pharmaceutical ingredient (placebo) consisting of starch and with an appearance completely similar to the original drug, every night for three months along with a splint similar to the Case group. Yes - There is a plan to make this available What will be shared: All data on study participants and clinical trial information can be shared after de-identification. When: The access period starts 6 months after the results are published To whom: Each potential individual with the approval of the principal investigators Conditions: There will be no exclusive criteria for data usage Where to obtain: raissi.gh@iums.ac.ir kzm.kamyar@gmail.com How to obtain: Sending the official request by email Data will be sent to you after the confirmation of the researcher Comments:
public Golam Reza Raissi
Iran University of Medical Sciences, Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8214 1612 raissi.gh@iums.ac.ir Iran University of Medical Sciences scientific Golam Reza Raissi
Iran University of Medical Sciences, Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8214 1612 raissi.gh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Pain or paresthesia or hypoesthesia in distal hand region or thenar weakness, with positive tinel or phalen tests No clinical evidence of cervical radiculopathy or radicular pain Negative history for Carpal Tunnel Release (CTR) surgery No injection inside or in proximity of carpal tunnel in last 3 months No present contraindication for Clemastine, such as drug allergy to antihistamine group Patient is willing to knowingly participate in a clinical trial 20 years 60 years Both Patient isn't cooperative for questionnaire completion Drug or alcohol addiction Major depressive disorder or uncontrolled psychiatric disorders Positive history for malignancy or infection in wrist or hand region History of ischemic or neurovascular injury in wrist or hand region Usage of other treatment measures during trial period Patient doesn't follow correct treatment plan regarding drug or splint usage G56.0 Carpal tunnel syndrome Treatment - Drugs Placebo Intervention group: 1 mg clemastine tablet every night along with CTS night splint (Volar cockup wrist splint, Prefabricated) for three months. Control group: Taking a placebo tablet without active pharmaceutical ingredient (placebo) consisting of starch and with an appearance completely similar to the original drug, every night for three months along with a splint similar to the Case group. Patient's pain intensity(Visual Analogue Scale). Timepoint: Before, after one month and after three months of intervention. Method of measurement: Using the Visual Analogue Scale. Median nerve sensory action potential amplitude. Timepoint: Before, after one month and after three months of intervention. Method of measurement: Nerve conduction study. Median nerve sensory action potential latency. Timepoint: Before, after one month and after three months of intervention. Method of measurement: Nerve conduction study. Median nerve motor action potential latency. Timepoint: Before, after one month and after three months of intervention. Method of measurement: Nerve conduction study. Median nerve motor action potential amplitude. Timepoint: Before, after one month and after three months of intervention. Method of measurement: Nerve conduction study. Iran University of Medical Sciences Approved 2022-12-21 Research Ethics Committees of Iran university of medical sciences, School of Medicin Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN Tehran Tehran Iran (Islamic Republic of)