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IRCT20150602022539N14 IRCT 2023-02-23 Semnan University of Medical Sciences The effect of electroacupuncture on sensory and motor function and electrophysiological components in spinal cord injury Investigating the effect of adding electroacupuncture to common rehabilitation treatments on improving sensory and motor function and electrophysiological components in spinal cord injury patients 2022-04-03 anticipated 20 Complete https://irct.ir/trial/68483 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: block Randomization unit: individual Randomization tool: random sequence generation software (Excel) Random Layers: Does not occur How to make a random sequence: The method of allocation to two groups will be Block Permuted Randomization in blocks of 4. Concealment of random allocation: does not take place, Blinding description: In this study, the therapist and the assessor (the one who evaluates the sensorimotor function using the ASIA form and the one who records the H-Reflex components) are different people, and the evaluator does not know what intervention the patient receives and also The statistician is also blind to the data. N/A Spinal Cord Injury. Intervention 1: Intervention group: The intervention group will receive common rehabilitation treatment 6 days a week for 8 weeks and electroacupuncture 5 days a week for 8 weeks. Common rehabilitation includes that each patient will receive 6 days a week and three sessions of physiotherapy each day for forty-five minutes and one work session for thirty minutes, with at least one hour of rest between sessions. and the exercises will include strengthening exercises, stretching and passive exercises to prevent deformity and maintain joint range and walking exercises، The electroacupuncture protocol includes 40 sessions 5 days a week for 8 weeks with a frequency of 1-5 Hz and a pulse width of 100 microseconds with an intensity of 1 to 10 millivolts in the area of ​​GV14, GV9, GV4, GV3, GV20, GV19 and Jiaji will be performed on the top and bottom of the injury site bilaterally for 30 minutes. Intervention 2: Control group: The control group will receive common rehabilitation treatment 6 days a week for 8 weeks and electroacupuncture 5 days a week for 8 weeks, but after a few seconds the device will be turned off and the needles will be removed. Common rehabilitation includes that each patient will receive 6 days a week and three sessions of physiotherapy each day for forty-five minutes and one work session for thirty minutes, with at least one hour of rest between sessions. and the exercises will include strengthening exercises, stretching and passive exercises to prevent deformity and maintain joint range and walking exercises. 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 Ziaeddin Safavi Farokhi
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
Semnan Iran (Islamic Republic of) 3013138111 +98 23 3365 4180 ziasafavi@yahoo.com Semnan University of Medical Sciences scientific Ziaeddin Safavi Farokhi
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
Semnan Iran (Islamic Republic of) 3013138111 +98 23 3365 4180 ziasafavi@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of Spinal Cord Injury with non-progressive causes characterized by spinal trauma. Neuroimaging tests, such as computed tomography, will be used to rule out more serious, progressive conditions such as nerve-destroying injuries, tumors, and demyelination. Patients with traumatic injury and relatively stable condition after spinal internal fixation surgery. Normal or normal heart, liver and kidney functions as well as coagulation functions. Being mentally and psychologically stable. Age range 18-45 years. Subacute traumatic spinal cord injury patients (maximum 18 months have passed since the injury) from the thoracic region and in groups B,C and D (based on the American Spinal Injury Association injury scale) will be studied. 18 years 45 years Both Uncontrolled blood pressure, severe heart and lung disease, severe orthostatic hypotension, deep vein thrombosis, severe osteoporosis, severe pressure ulcers and cognitive dysfunction, diabetes, hypersensitivity to needles. Fear of needles. Pregnancy, osteomyelitis of vertebrae, tumor, ankylosing spondylitis. The presence of serious mental injuries such as suicidal thoughts. People suffering from complications such as hematoma or severe pain during the study. Lack of consent to continue the tests. People's inability to continue rehabilitation and intervention due to medical reasons. Participation of individuals in intensive rehabilitation programs that may bias the results will also be excluded. S24.0 Concussion and edema of thoracic spinal cord Treatment - Devices Treatment - Devices Intervention group: The intervention group will receive common rehabilitation treatment 6 days a week for 8 weeks and electroacupuncture 5 days a week for 8 weeks. Common rehabilitation includes that each patient will receive 6 days a week and three sessions of physiotherapy each day for forty-five minutes and one work session for thirty minutes, with at least one hour of rest between sessions. and the exercises will include strengthening exercises, stretching and passive exercises to prevent deformity and maintain joint range and walking exercises، The electroacupuncture protocol includes 40 sessions 5 days a week for 8 weeks with a frequency of 1-5 Hz and a pulse width of 100 microseconds with an intensity of 1 to 10 millivolts in the area of ​​GV14, GV9, GV4, GV3, GV20, GV19 and Jiaji will be performed on the top and bottom of the injury site bilaterally for 30 minutes. Control group: The control group will receive common rehabilitation treatment 6 days a week for 8 weeks and electroacupuncture 5 days a week for 8 weeks, but after a few seconds the device will be turned off and the needles will be removed. Common rehabilitation includes that each patient will receive 6 days a week and three sessions of physiotherapy each day for forty-five minutes and one work session for thirty minutes, with at least one hour of rest between sessions. and the exercises will include strengthening exercises, stretching and passive exercises to prevent deformity and maintain joint range and walking exercises. ASIA form sensory sub-item score - ASIA form motor sub-item score - H-reflex amplitude - H-reflex latency. Timepoint: Before treatment, immediately after 40 sessions of treatment. Method of measurement: ASIA form EMG recording device. Semnan University of Medical Sciences Approved 2023-02-06 Ethic committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Kilometer 5 Damghan road, Semnan Semnan Semnan Iran (Islamic Republic of)