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IRCT20211225053519N2 IRCT 2022-01-10 Iran University of Medical Sciences Comparing open and closed thread surgical techniques in carpal tunnel syndrome Comparing the surgical outcomes of carpal tunnel syndrome treatment between open carpal tunnel release (OCTR) and thread carpal tunnel release (TCTR) 2022-01-21 anticipated 20 Complete https://irct.ir/trial/61160 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the simple randomization method. Random allocation software is also used as the randomization tool. The allocation concealment will be used for hiding so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequences, each of the random sequences created is recorded on a card, and the cards are placed in the envelopes, respectively. To maintain a random series, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order, and the assigned group of the participant is revealed. N/A Carpal Tunnel Syndrome. Intervention 1: Intervention group: In the open surgery group, after a 1 cm incision, the proximal wrist groove will open and after exposing the median nerve, the guiding groove will pass from inside to the fourth finger and then the ligament will be released using scissors. Intervention 2: Intervention group: In the thread surgery group, after determining the safe zone points and opening the palmar fascia, and inserting the endoscope from the proximal to the distal part of the safe zone, a nylon thread No. 1 will pass from the distal to the proximal region below the transverse carpal ligament (TCL) and the TCL will release by abrasion and friction moves. Yes - There is a plan to make this available What will be shared: All Deidentified Individual Participant Data Set will be available after the end of the study When: 6 months after publishing the results To whom: Researchers who work in an academic institute Conditions: Data is given to the researchers just for assessment and not for interfering Where to obtain: Through email: Me_service22@yahoo.com How to obtain: The data will given to researchers after assessing the eligibility through email Comments:
public Mohammad Amin Shahrbaf
21th Alley, Seyed Jamaloddin Asad Abadi St., Tehran, Iran
Tehran Iran (Islamic Republic of) 14665354 +98 21 8871 7272 Aminshahrbaf41@gmail.com Iran University of Medical Sciences scientific Mohammad Amin Shahrbaf
21th Alley, Seyed Jamaloddin Asad Abadi St., Tehran, Iran
Tehran Iran (Islamic Republic of) 14665354 +98 21 8871 7272 Aminshahrbaf41@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Clinical symptoms of carpal tunnel syndrome Positive Phalen Test Mild cases of carpal tunnel syndrome (sensory nerve action potential (SNAP) more than 3.6 m.s in the electrodiagnostic study) Moderate cases of carpal tunnel syndrome (sensory nerve action potential (SNAP) more than 3.6 m.s and compound muscle action potential (CMAP) more than 4.2 m.s in the electrodiagnostic study) Lack of responses to non-surgical treatments no limit no limit Both Thenar atrophy Severe cases of carpal tunnel syndrome (lack of sensory nerve action potential (SNAP) and compound muscle action potential (CMAP) and nerve conduction velocity (NCV) less than 40 m/s across the wrist) Neurodegenerative or demyelinating diseases History of surgical treatment for carpal tunnel syndrome in last 6 months History of corticosteroid injection for carpal tunnel syndrome in last 6 months Lack of consent for inclusion into the study G56 Mononeuropathies of upper limb Treatment - Surgery Treatment - Surgery Intervention group: In the open surgery group, after a 1 cm incision, the proximal wrist groove will open and after exposing the median nerve, the guiding groove will pass from inside to the fourth finger and then the ligament will be released using scissors. Intervention group: In the thread surgery group, after determining the safe zone points and opening the palmar fascia, and inserting the endoscope from the proximal to the distal part of the safe zone, a nylon thread No. 1 will pass from the distal to the proximal region below the transverse carpal ligament (TCL) and the TCL will release by abrasion and friction moves. Scar length in centimeter. Timepoint: 3 month after the surgery. Method of measurement: Direct observation. Postsurgical pain. Timepoint: One day after the surgery. Method of measurement: Visual analog score (VAS). Operation time in minute. Timepoint: During the operation. Method of measurement: Assessing the minutes by clock. Two point discriminations in thumb and index fingers. Timepoint: One month after the surgery. Method of measurement: Sensing two point discriminations based on millimeters. Monofilament test. Timepoint: One month after the operation. Method of measurement: Monofilament assessment. Electrodiagnostic assessment. Timepoint: One month after the operation. Method of measurement: Electrodiagnostic study. Iran University of Medical Sciences Approved 2019-08-07 Research Ethics Committees of School of Medicine, Iran University of Medical Sciences Tehran Hemat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)