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IRCT20190810044492N1 IRCT 2023-03-15 Arak University of Medical Sciences Investigating the effect of tenosynovectomy on the Improve the severity of symptoms in patients with carpal tunnel syndrome after open surgery Investigating the effect of tenosynovectomy on the Improve the severity of symptoms in patients with carpal tunnel syndrome after open surgery 2023-03-01 anticipated 60 Complete https://irct.ir/trial/68883 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, due to the presence of two types of surgical techniques, the block randomization method will be used. The randomization unit is the person. According to the sample size, blocks with a capacity of 4 units were considered. By assigning the letter A to the intervention group and the letter B to the control group, there are six states AABB, BBAA, BABA, ABBA, BAAB and ABAB. Then it is randomly selected from among these situations and a list equal to the sample size is prepared for patients before the start of the study. For better randomization, the web software will be used to prepare the randomization list, which creates random permutations for both types of treatment in each block, and according to the change of permutations in each block, concealment is also observed. During the implementation of the study, the predictability of the treatment for each patient is reduced by the researcher. Site used for random permutation block method: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: In this study, the patient is blinded. The study is of a blind type. Informed consent is obtained from the patient that one of the surgical procedures will be performed without and with tenosinectomy. But in the end, the patient will not understand the type of surgical technique. N/A carpal tunnel syndrome. Intervention 1: Intervention group: In this group, carpal tunnel syndrome sufferers will undergo CTS surgery with tenosynovectomy or removal of the tendon sheath (a layer of the membrane around the tendon) and they will be examined for symptoms and subtle movements after the surgery. Intervention 2: Control group: In this group, carpal tunnel syndrome sufferers will undergo CTS surgery without tenosynovectomy or removal of the tendon sheath (a layer of the membrane surrounding the tendon) and will be examined for symptoms and subtle movements after the surgery. 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 There is no further information
public Ahmadreza Behruzi
Valiasr Hospital
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3605 mjaras@yahoo.com Arak University of Medical Sciences scientific Ahmadreza Behruzi
Valiasr Hospital
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3605 mjaras@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients with carpal tunnel syndrome aged 20 to 70 years Positive electrodiagnostic tests Absence of thenar atrophy The absence of old fractures in the forearm and wrist Absence of any congenital deformity in the forearm and wrist area Absence of rheumatic diseases such as rheumatoid arthritis 20 years 70 years Both Patient's lack of consent to continue the study Non-cooperation of the patient Failure to visit the patient G56.1 Other lesions of median nerve Treatment - Surgery Treatment - Surgery Intervention group: In this group, carpal tunnel syndrome sufferers will undergo CTS surgery with tenosynovectomy or removal of the tendon sheath (a layer of the membrane around the tendon) and they will be examined for symptoms and subtle movements after the surgery. Control group: In this group, carpal tunnel syndrome sufferers will undergo CTS surgery without tenosynovectomy or removal of the tendon sheath (a layer of the membrane surrounding the tendon) and will be examined for symptoms and subtle movements after the surgery. Severity of symptoms. Timepoint: Improvement of the severity of symptoms one day before the operation and one day after the operation and the first week and 3 months after the operation. Method of measurement: Boston Questionnaire (to evaluate the severity of symptoms and functional status of carpal tunnel syndrome in people) will be used to check the patient's symptoms. Evaluation of the function and fine movements of the fingers. Timepoint: Fine movements and hand function one day before the operation and 3 months after the operation and in terms of improvement of symptoms, one day before the operation and one day after the operation and the first week and 3 months after the operation. Method of measurement: The O'Connor Tweezer Dexterity Test will be used to check fine finger movements. This device is a valid and widely used manual dexterity test. It is used by rehabilitation professionals to assess progress in the recovery of hand and finger function, as well as to assess fine motor skills. The O'Connor Dexterity Test simply requires the user to pick up pins with the provided tweezers and insert them into a series of holes. A high score on this test indicates manual aptitude for tasks that involve the use of small precision tools such as clock assembly. Arak University of Medical Sciences Approved 2023-01-08 Ethics committee of Arak University of Medical Sciences No. 5, Sardasht Ave., Basij Blvd Arak Markazi Iran (Islamic Republic of)