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IRCT20160614028447N8 IRCT 2020-09-06 Shiraz University of Medical Sciences Comparison of the effects of nerve mobilization and use of orthosis on median nerve stiffness in patients with carpal tunnel syndrome Comparison of the effects of neurodynamic mobilization and use of orthosis on median nerve stiffness in patients with carpal tunnel syndrome by sonoelastography 2020-11-20 anticipated 36 Complete https://irct.ir/trial/50633 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified randomization would be performed according to severity of the disease. In each stratum of weak, medium and severe, a separate randomization list is designed, which is based on the permutation block method, and we considered 3 blocks of 4 in each of them. Using random number generator software, random sequences of numbers 0 and 1 are generated and based on that, patients are divided into two treatment groups, Blinding description: This study is a one-way blind trial study in which the person performing the sonoelastography evaluation is unaware of the patient's treatment and in order to perform the blinding process, tests and treatments would be done in independent centers and by different people and each of them is unaware of other processes. N/A Carpal Tunnel Syndrome. Intervention 1: First intervention group: In neurodynamic technique intervention group, treatment will be done using neurodynamic techniques in median nerve in a supine lying position. Neurodynamic sequence will be as follows: 90 degrees arm abduction, arm external rotation, wrist and hand extension, elbow supination and elbow extension. In this sequence, glide and tension techniques will be done in proximal and distal directions: 1- Glide proximal mobilization (high-amplitude extension movement of the elbow joint), 2- Glide distal mobilization (high-amplitude extension movement of the wrist joint), 3- Tension proximal mobilization (low-amplitude extension movement of the elbow joint at end range), 4- Tension distal mobilization (low-amplitude extension movement of the wrist joint). Neurodynamic protocol includes 3 sets of 60 repetitions of neurodynamic techniques of sliding and tension with 15 seconds rest between each set. Each session lasts for 20 minutes. The intervention would be done once daily for a week. Intervention 2: Second intervention group: In orthosis intervention group, immobilization would be done by a night wrist-hand orthosis in neutral position and the person is asked to wear it every night for 8 hours and continue it for a week. The orthosis is made specifically for each patient and is made of thermoplastic to be able to keep the wrist in exact neutral position. Yes - There is a plan to make this available What will be shared: All data except personal information would be available. When: The start of the access period is 6 months after the acceptance of the article. To whom: In addition to the principal researcher and the supervisor of the project, upon request, access to information can be reviewed by the Ethics Committee. Conditions: Researchers can use data for advanced analyses or for meta analysis studies. Where to obtain: Dr. Amin KordiYoosefinejad, Shiraz, Chamran Blvd., Sheikh Abivardi 1 ave., School of Rehabilitation Sciences, Mobile: 09171950589, E-mail: yoosefinejad@sums.ac.ir How to obtain: After 6 months from article acceptance, while announcing a written request to the executor of the project to receive information and a precise explanation about how to use the information, an official letter is also requested to obtain permission from the ethics committee to obtain a license, and if the ethics committee approves, emphasizing the confidentiality of the information, the requested information will be provided to the applicant. Comments:
public Sahar Khademi
No. 62, Kavoosi Ave., Sardaran Blvd, Shiraz
Shiraz Iran (Islamic Republic of) 71559-66991 +98 71 3740 8440 khademi.sahar21@gmail.com Shiraz University of Medical Sciences scientific Sahar Khademi
No. 62, Kavoosi Ave., Sardaran Blvd, Shiraz
Shiraz Iran (Islamic Republic of) 71559-66991 +98 71 3740 8440 khademi.sahar21@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Having CTS according to diagnosis criteria of increased sensory or distal motor latency Having symptoms of CTS for at least one month 18 years 65 years Both History of surgical interventions in wrist area Having received intervention related to CTS for three months before the examination History of steroid injection for CTS in the studied hand 6 months before the examination Joint inflammatory disease If CTS is associated with pregnancy or diabetes Inability to complete questionnaires due to cognitive problems G56.0 Carpal tunnel syndrome Rehabilitation Rehabilitation First intervention group: In neurodynamic technique intervention group, treatment will be done using neurodynamic techniques in median nerve in a supine lying position. Neurodynamic sequence will be as follows: 90 degrees arm abduction, arm external rotation, wrist and hand extension, elbow supination and elbow extension. In this sequence, glide and tension techniques will be done in proximal and distal directions: 1- Glide proximal mobilization (high-amplitude extension movement of the elbow joint), 2- Glide distal mobilization (high-amplitude extension movement of the wrist joint), 3- Tension proximal mobilization (low-amplitude extension movement of the elbow joint at end range), 4- Tension distal mobilization (low-amplitude extension movement of the wrist joint). Neurodynamic protocol includes 3 sets of 60 repetitions of neurodynamic techniques of sliding and tension with 15 seconds rest between each set. Each session lasts for 20 minutes. The intervention would be done once daily for a week. Second intervention group: In orthosis intervention group, immobilization would be done by a night wrist-hand orthosis in neutral position and the person is asked to wear it every night for 8 hours and continue it for a week. The orthosis is made specifically for each patient and is made of thermoplastic to be able to keep the wrist in exact neutral position. Median nerve stiffness. Timepoint: At the beginning of study (before intervention) and at the end of study (after 1 week of intervention). Method of measurement: Sonoelastography. Symptom severity and function. Timepoint: At the beginning of study (before intervention) and at the end of study (after 1 week of intervention). Method of measurement: Boston Carpal Tunnel Syndrome Questionnaire. Nerve conduction velocity. Timepoint: At the beginning of study (before intervention) and at the end of study (after 1 week of intervention). Method of measurement: Electrodiagnosis. Shiraz University of Medical Sciences Approved 2020-08-19 National Committee on Ethics in Biomedical Research Sheikh Abivardi 1, Chamran Blvd., Shiraz Shiraz Fars Iran (Islamic Republic of)