]>
IRCT20191208045652N5 IRCT 2022-12-07 Iran University of Medical Sciences The effect of electroacupuncture in carpal tunnel syndrome The effect of neurodynamic techniques and Electroacupuncture on pain, grip strength and hand function in subject with carpal tunnel syndrome: Randomized control trial 2023-01-20 anticipated 38 Complete https://irct.ir/trial/66307 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the completion of participant information and questionnaires, patients with carpal tunnel syndrome are randomly divided into two groups of treatment (group A) and control group (group B) with a ratio of one to one. Random allocation is done by variable blocks method, which will include four-letter blocks consisting of letters A and B. In each numbered envelope, one of the four-letter blocks containing two letters A and B is placed. Then, the treatment allocation list will be obtained at https://www.randomizer.org/.The letter A indicates electroacupuncture group and the letter B indicates non-real electroacupuncture. The random allocation process will be done by someone outside of the research team before the start of the study. After the initial evaluation of the patient by the examiner, numbered envelopes and stamps corresponding to the number of each person entered into the study will be given to him. Finally, after each patient enters the treatment sessions, the person providing the techniques will adjust the treatment interventions based on the letters inside the envelope. The examiners will be completely unaware of the letters inside the envelopes. Also, it should be noted that after placing the patients in the desired group, they are asked not to provide their grouping information to the examiner, Blinding description: Evaluation and treatment will be done by two people. The person evaluating and analyzing the data are those who do not know about the grouping and will be unaware of which group each subject belongs to. The evaluator is present in the research only during the evaluation. The participants will not know which treatment group they have entered, in the treatment group, electroacupuncture along with neurodynamic techniques will be used, and in the control group, electroacupuncture placebo along with neurodynamic techniques will be used. N/A Carpal Tunnel Syndrome. Intervention 1: Intervention group: Neurodynamic technique: arm adduction to 90, arm external rotation, wrist and fingers extension, forearm supination, and elbow extension. In this sequence, gliding and tension techniques will perform in the proximal and distal directions: (1) 1-direction proximal glide mobilization (movement_elbow extension_large amplitude of motion), (2) 1-direction distal glide mobilization (movement_wrist extension_large amplitude of motion), (3) 1-direction proximal tension mobilization (movement_elbow extension_small amplitude of motion at the end of the movement), and (4) 1-direction distal tension mobilization (movement_wrist extension_small amplitude of motion)In both groups, the standard protocol consisted of 3 series of 20 repetitions of glide and tension neurodynamic techniques separated by inter-series intervals of 15 seconds, twice a week for 10 sessions. Electroacupuncture: The following eight acupoints were applied: TW-5, PC-7, HT-3, PC-3, SI-4, LI-5, LI-10 and LU-5 on the affected side. After disinfecting the skin, therapist would insert sterile, 0.25x40 mm, into each acupoint with the aid of a guide tube. Punctures will make to a depth of 1–3 cm, depending on the thickness of the patient’s wrist, hand and forearm. After insertion would perform bidirectional rotations of the needle sheath to achieve Deqi, indicating a patient-reported sensation of soreness, tingling, heaviness or distension at each acupoints. After insertion of all acupoints, electro-stimulation will apply immediately in the following combinations: TW-5 + PC-7, SI-4 + LI-5, LI-10 + LU-5, and HT-3 + PC-3, using the SDZ-II electroacupuncture instrument (2-4 Hz, continuous wave). The intensity should tolerable to the patient. The electro-simulation lasted for 20 minutes and then needles will remove, twice a week for 10 sessions. Intervention 2: Control group: Neurodynamic technique: arm adduction to 90, arm external rotation, wrist and fingers extension, forearm supination, and elbow extension. In this sequence, gliding and tension techniques will perform in the proximal and distal directions: (1) direction proximal glide mobilization (movement_elbow extension_large amplitude of motion), (2) direction distal glide mobilization (movement_wrist extension_large amplitude of motion), (3) direction proximal tension mobilization (movement_elbow extension_small amplitude of motion at the end of the movement), and (4) direction distal tension mobilization (movement_wrist extension_small amplitude of motion)In both groups, standard protocol consisted of 3 series of 20 repetitions of glide and tension neurodynamic techniques separated by inter-series intervals of 15 seconds, twice a week for 10 sessions. Sham electroacupuncture: After disinfecting the skin, sham EA on therapeutic acupoints plus no skin penetration plus no electrical stimulation. After 20 minutes needles will remove, twice a week for 10 sessions. 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 Hasti Lotfi
Golestan Dormitory, Madadkaran street, Shahid Shahnazari street, Madar square, Mirdamad boulevard
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2225 6434 Hlhastilotfi@gmail.com Iran University of Medical Sciences scientific Marzieh Yassin
Physical therapy department, Rasoul Akram hospital, Niayesh street, Sattarkhan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 2222 8052 m.yassin.pt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 18_60 year old Symptoms associated with carpal tunnel syndrome (pain and numbness) in at least 2 of the outer 3½ fingers for a period of one to six months Participants who have diminished nerve conduction values (<50 m/s), increased motor latency (>4 m/s), and increased sensory latency (> 3.5 m/s) Positive phalen and tinel sign 18 years 60 years Both Thenar muscle atrophy Pregnancy Prior decompression surgery History of trauma in wrist and hand Metabolic problems (diabetes mellitus in case of insulin use or diabetic neuropathy) Cervical radiculopathy Any contraindication for needling such as local infection, bleeding tendency or a history of needling shock Rheumatoid diseases G56.00 Carpal tunnel syndrome, unspecified upper limb Rehabilitation Rehabilitation Intervention group: Neurodynamic technique: arm adduction to 90, arm external rotation, wrist and fingers extension, forearm supination, and elbow extension. In this sequence, gliding and tension techniques will perform in the proximal and distal directions: (1) 1-direction proximal glide mobilization (movement_elbow extension_large amplitude of motion), (2) 1-direction distal glide mobilization (movement_wrist extension_large amplitude of motion), (3) 1-direction proximal tension mobilization (movement_elbow extension_small amplitude of motion at the end of the movement), and (4) 1-direction distal tension mobilization (movement_wrist extension_small amplitude of motion)In both groups, the standard protocol consisted of 3 series of 20 repetitions of glide and tension neurodynamic techniques separated by inter-series intervals of 15 seconds, twice a week for 10 sessions. Electroacupuncture: The following eight acupoints were applied: TW-5, PC-7, HT-3, PC-3, SI-4, LI-5, LI-10 and LU-5 on the affected side. After disinfecting the skin, therapist would insert sterile, 0.25x40 mm, into each acupoint with the aid of a guide tube. Punctures will make to a depth of 1–3 cm, depending on the thickness of the patient’s wrist, hand and forearm. After insertion would perform bidirectional rotations of the needle sheath to achieve Deqi, indicating a patient-reported sensation of soreness, tingling, heaviness or distension at each acupoints. After insertion of all acupoints, electro-stimulation will apply immediately in the following combinations: TW-5 + PC-7, SI-4 + LI-5, LI-10 + LU-5, and HT-3 + PC-3, using the SDZ-II electroacupuncture instrument (2-4 Hz, continuous wave). The intensity should tolerable to the patient. The electro-simulation lasted for 20 minutes and then needles will remove, twice a week for 10 sessions. Control group: Neurodynamic technique: arm adduction to 90, arm external rotation, wrist and fingers extension, forearm supination, and elbow extension. In this sequence, gliding and tension techniques will perform in the proximal and distal directions: (1) direction proximal glide mobilization (movement_elbow extension_large amplitude of motion), (2) direction distal glide mobilization (movement_wrist extension_large amplitude of motion), (3) direction proximal tension mobilization (movement_elbow extension_small amplitude of motion at the end of the movement), and (4) direction distal tension mobilization (movement_wrist extension_small amplitude of motion)In both groups, standard protocol consisted of 3 series of 20 repetitions of glide and tension neurodynamic techniques separated by inter-series intervals of 15 seconds, twice a week for 10 sessions. Sham electroacupuncture: After disinfecting the skin, sham EA on therapeutic acupoints plus no skin penetration plus no electrical stimulation. After 20 minutes needles will remove, twice a week for 10 sessions. Functional status scale of Boston questionnaire. Timepoint: The first session before treatment, at the end of the 5th session, 48 hours after the 10th session, two months after the end of the treatment. Method of measurement: Persian Boston Questionnaire. Symptom severity scale of Boston Questionnaire. Timepoint: The first session before treatment, at the end of the 5th session, 48 hours after the 10th session, two months after the end of the treatment. Method of measurement: Persian Boston Questionnaire. Pain. Timepoint: The first session before treatment, at the end of the 5th session, 48 hours after the 10th session, two months after the end of the treatment. Method of measurement: numeric pain rating scale. Grip strength. Timepoint: The first session before treatment, at the end of the 5th session, 48 hours after the 10th session. Method of measurement: Hand dynamometer. Iran University of Medical Sciences Approved 2022-09-18 Ethics committee of Iran university of medical sciences Iran university of medical sciences, next to Milad tower, Hemmat highway Tehran Tehran Iran (Islamic Republic of)