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IRCT20191208045652N3 IRCT 2021-03-18 Iran University of Medical Sciences Effect of TECAR therapy and neurodynamic techniques in treatment of carpal tunnel syndrome. The effectiveness of TECAR therapy and neurodynamic techniques VS. neurodynamic techniques and placebo TECAR on pain and function in subjects with carpal tunnel syndrome. 2021-01-19 anticipated 30 Complete https://irct.ir/trial/52902 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method is used.Randomization tool is also a software for random sequence production (software allocation Random).A set of random numbers is given by the software and before starting the study, it is determined that the intervention group of even numbers is assigned to the control group of odd numbers. Concealment Allocation is used for hiding, Which refers to the method used to execute a random sequence on study participants, in such a way that the assigned group is not known before the individual is assigned.Using opaque envelopes sealed in random sequence in this method, each of the random sequences created is recorded on a card and the cards are placed in the envelopes of the letter, respectively.In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface.Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the time of registration of participants, based on the order in which eligible participants enter the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: Evaluation and treatment are performed by two people.The person evaluating and analyzing the data are those who do not know about grouping. The evaluator is present in the research only at the time of evaluation (before and after treatment). N/A Carpal Tunnel Syndrome. Intervention 1: In this study, TECAR (winback made in France) is used. The frequency used is 300 kHz which is selected due to the use of metal electrodes and the lack of high heat and burns. The patient is asked to sit on a chair and put their hand in supine position comfortably on a table in front of them. Current is applied to the transverse ligament of the wrist for 20 minutes using a resistance electrode with gel. The counter electrode is placed on the dorsal surface of the wrist. Treatment is done in 5 sessions and 2 times a week. In order to perform the neurodynamic technique of the median nerve, the patient is first asked to lie in supine position on the treatment bed. The therapist is then placed next to the bed and the patient's shoulder is taken to the depression. Meanwhile, the arm is placed in abduction and external rotation. In the next step, the forearm is taken to supination. Finally, while the patient's elbow is flexed, the wrists and fingers are extended Then, by extending the patient's elbow, therapist flex the wrists and fingers. The speed and intensity of the movement should be such that it does not cause pain to the patient. Treatment is done in 5 sessions 2 times a week. The technique is applied in each session in 3 sets of 60 with a 30 second interval between each set. Intervention 2: Control group: placebo TECAR with neurodynamic techniques, Placebo TECAR is applied by the therapist to the transverse ligament of the wrist. All of the parameters similar to the treatment group, are performed on the transverse ligament of the wrist for 20 minutes but TECAR is silent. After the TECAR therapy the neurodynamic technique of median nerve slippage is performed. A total of 6 sessions of treatment are performed. Each session is 60 minutes. Yes - There is a plan to make this available What will be shared: All data can be shared after identifying individuals. When: 6 months after printing the results To whom: The information is available to all researchers working in academic and scientific institutions. Conditions: It is possible only by mentioning the name and organizational affiliation of the executor and colleagues of the project. Where to obtain: M.yassin.pt@gmail.com How to obtain: If the data is used in scientific and therapeutic activities, the information is provided to individuals as soon as possible. Comments:
public Seyyede Elnaz Hashemi
Mirdamad, Mother Square, Nezam Ave
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 2059 eli.hshmi@gmail.com Iran University of Medical Sciences scientific Marzieh Yassin
Rasool Akram Hospital, Sattar Khan
Tehran Iran (Islamic Republic of) 1445613131 091222222508 m.yassin.pt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with age range of 18-60 years ol Pain and paresthesia in at least 2 fingers of 3/5 lateral fingers for 1-6 months. Diagnosis of CTS based on EMG tests (distal motor latency>4m.s and distal sensory latency >5/3 m.s) Positive Phalen and Tinel test Ability to read and write in Persian 18 years 60 years Both pregnancy Thenar atrophy history of any hand or wrist surgery Metabolic diseases (Diabetes mellitus, thyroid or kidney problem) cervical radiculopathy Fibromyalgia or other musculoskeletal disorders Any history of severe trauma to the wrist and Connective tissue disorders Patient dissatisfaction with the continuation of the treatment and evaluation process G56.0 Carpal tunnel syndrome Treatment - Other Treatment - Other In this study, TECAR (winback made in France) is used. The frequency used is 300 kHz which is selected due to the use of metal electrodes and the lack of high heat and burns. The patient is asked to sit on a chair and put their hand in supine position comfortably on a table in front of them. Current is applied to the transverse ligament of the wrist for 20 minutes using a resistance electrode with gel. The counter electrode is placed on the dorsal surface of the wrist. Treatment is done in 5 sessions and 2 times a week. In order to perform the neurodynamic technique of the median nerve, the patient is first asked to lie in supine position on the treatment bed. The therapist is then placed next to the bed and the patient's shoulder is taken to the depression. Meanwhile, the arm is placed in abduction and external rotation. In the next step, the forearm is taken to supination. Finally, while the patient's elbow is flexed, the wrists and fingers are extended Then, by extending the patient's elbow, therapist flex the wrists and fingers. The speed and intensity of the movement should be such that it does not cause pain to the patient. Treatment is done in 5 sessions 2 times a week. The technique is applied in each session in 3 sets of 60 with a 30 second interval between each set. Control group: placebo TECAR with neurodynamic techniques, Placebo TECAR is applied by the therapist to the transverse ligament of the wrist. All of the parameters similar to the treatment group, are performed on the transverse ligament of the wrist for 20 minutes but TECAR is silent. After the TECAR therapy the neurodynamic technique of median nerve slippage is performed. A total of 6 sessions of treatment are performed. Each session is 60 minutes. Pain. Timepoint: At the beginning and the end of each session and two months after the end of the last treatment session. Method of measurement: visual analogue scale. Grip strength. Timepoint: At the beginning and the end of each session and two months after the end of the last treatment session. Method of measurement: Hand held dynamo meter. Functional status scale of Boston questionnaire. Timepoint: Before treatment, at the end of third session and two months after the end of the last treatment session. Method of measurement: Persian Boston Questionnaire. Symptom severity scale of Boston Questionnaire. Timepoint: Before treatment, at the end of third session and two months after the end of the last treatment session. Method of measurement: Persian Boston Questionnaire. Iran University of Medical Sciences Approved 2020-11-06 Ethics committee of Iran University of Medical Sciences Nezam Ave, Madar Blvd, Mirdamad Tehran Tehran Iran (Islamic Republic of)