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IRCT20210613051566N1 IRCT 2021-12-17 Tehran University of Medical Sciences Comparison of Ultrasound‐Guided Median nerve Hydrodissection with Corticosteroid Injection in the treatment of mild to moderate Carpal Tunnel Syndrome Comparison of Ultrasound‐Guided Median nerve Hydrodissection with Corticosteroid Injection in the treatment of mild to moderate Carpal Tunnel Syndrome 2021-12-22 anticipated 60 Complete https://irct.ir/trial/60183 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with help of www.sealedenvelope.com website. According to treatment groups, block sizes and list length, the website generates a list of random codes consisting of an English letter and digits. These codes are printing the codes on a card, and placing the cards in a sealed envelope (SNOSE method). After generating the list, each code will be printed on one card that, after shuffling, are placed in envelopes. Each patient will be given an envelope to assign to one of the groups. Also, in a separate list, the person is assigned to the code taken out of the envelope, Blinding description: In this study participants and outcomes assessor are masked. N/A Carpal tunnel syndrome. Intervention 1: Intervention group: Patients in this group will undergo a Ultrasound-guided Median nerve hydrodissection with corticosteroid injection. Total of 5cc solution consisting of 1cc of Triamcinolone acetonide (40mg), 1cc of lidocaine, and 3cc of saline is used. Using ultrasound guidance and aseptic technique, the needle will be inserted from an ulnar approach, then be angled deep to inject 2 ml of mixture for separating nerve from Flexor tendons beneath. The needle will then be angled superficial to the median nerve and 3ml of mixture will be injected to to peel the median nerve off the overlying flexor retinaculum. Intervention 2: Intervention group: Patients in this group will undergo a Ultrasound-guided Median nerve hydrodissection without corticosteroid injection. Total of 5cc solution consisting of 1cc of lidocaine, and 4cc of saline is used. Using ultrasound guidance and aseptic technique, the needle will be inserted from an ulnar approach, then be angled deep to inject 2 ml of mixture for separating nerve from Flexor tendons beneath. The needle will then be angled superficial to the median nerve and 3ml of mixture will be injected to to peel the median nerve off the overlying flexor retinaculum. Intervention 3: Control group: Patients in this group will undergo a routine and standard Corticosteroid injection for CTS treatment. Using ultrasound guidance and aseptic technique, the needle will be inserted from an ulnar approach, and 1ml of Triamcinolone acetonide (40mg) will be injected into the area above Median nerve without separating the nerve from surrounding structures. Yes - There is a plan to make this available What will be shared: The data of the study participants will be evaluated for statistical analysis, and their results will be published in the form of an article. When: Immediately after the publication of the results in the form of a scientific article, the results of data analysis will be available to researchers at the request of the data. To whom: Researchers of this project and individuals who have the right to access the project data based on the written permission of the corresponding researcher can access the project data. Conditions: If the permission of the main researcher of the project is obtained with an acceptable justification and explanation, the data obtained from this project can be used. Where to obtain: Imam Khomeini Hospital Complex, Physical Medicine and Rehabilitation department, Dr Mohadese Azadvari How to obtain: A written request will be sent to the researcher in charge of the study with appropriate evidence and justification; Once approved by him, access to data and documents will be possible. Comments:
public Sahar Ghorbanpour
No.1. Aghili St. Aazodi Ave. Karimkhan St. Tehran
Tehran Iran (Islamic Republic of) 1598684813 +98 21 8870 1551 sahar.ghorbanpour@gmail.com Tehran University of Medical Sciences scientific Mohadese Azadvari
Physical medicine and rehabilitation department, Sina hospital, Hassan Abad square
Tehran Iran (Islamic Republic of) 1418733141 +98 21 61190 drazadvari@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Confirmed clinical and Electrophysiological diagnosis of Carpal Tunnel Syndrome with mild to moderate degree 18 years 80 years Both Confirmed clinical and Electrophysiological diagnosis of CTS with severe degree Patients with suspicious of CTS mimic condition, including cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome Recent corticosteroid injection to the carpal tunnel within 6 months Previous history of carpal tunnel surgical release Steroid injection contraindications Pregnancy Cancer Coagulopathy G56.0 Carpal tunnel syndrome Treatment - Other Treatment - Other Treatment - Other Intervention group: Patients in this group will undergo a Ultrasound-guided Median nerve hydrodissection with corticosteroid injection. Total of 5cc solution consisting of 1cc of Triamcinolone acetonide (40mg), 1cc of lidocaine, and 3cc of saline is used. Using ultrasound guidance and aseptic technique, the needle will be inserted from an ulnar approach, then be angled deep to inject 2 ml of mixture for separating nerve from Flexor tendons beneath. The needle will then be angled superficial to the median nerve and 3ml of mixture will be injected to to peel the median nerve off the overlying flexor retinaculum. Intervention group: Patients in this group will undergo a Ultrasound-guided Median nerve hydrodissection without corticosteroid injection. Total of 5cc solution consisting of 1cc of lidocaine, and 4cc of saline is used. Using ultrasound guidance and aseptic technique, the needle will be inserted from an ulnar approach, then be angled deep to inject 2 ml of mixture for separating nerve from Flexor tendons beneath. The needle will then be angled superficial to the median nerve and 3ml of mixture will be injected to to peel the median nerve off the overlying flexor retinaculum. Control group: Patients in this group will undergo a routine and standard Corticosteroid injection for CTS treatment. Using ultrasound guidance and aseptic technique, the needle will be inserted from an ulnar approach, and 1ml of Triamcinolone acetonide (40mg) will be injected into the area above Median nerve without separating the nerve from surrounding structures. Boston carpal tunnel syndrome questionnaire (BCTQ). Timepoint: Pre-treatment, 1st, 3rd and 6th months after injection. Method of measurement: five-point rating scale questionnaire. Visual Analog Scale (VAS) for Pain. Timepoint: Pre injection, 2 weeks, 1, 3 and 6 months intervals. Method of measurement: Visual and numeric scale. Cross-sectional area of the Median nerve. Timepoint: Pre injection, 1, 3 and 6 months intervals. Method of measurement: Ultrasound device. Conduction Velocity, Distal Latency and Amplitude of Median nerve SNAP & CMAP. Timepoint: Pre injection, 1, 3 and 6 months intervals. Method of measurement: EMG- NCV. Hand grip strength. Timepoint: Pre injection, 1, 3 and 6 months intervals. Method of measurement: Dynamometer. Tehran University of Medical Sciences Approved 2021-02-28 Ethics committee of Tehran University of Medical Sciences, Sina hospital Room 605، Secretariat of the Ethics Committee in University Biomedical Research، Vice Chancellor for Research and Technology, 6th Floor, Central University Organization, Corner of Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)