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IRCT20220228054149N1 IRCT 2022-04-04 Tehran University of Medical Sciences Investigating the Effect of Brain Stimulation on Balance The Effect of Transcranial Electrical Stimulation of the Primary Motor and Sensory Cortex on the Feed-forward and Feedback Strategies in Response to Predictable External Perturbations in Patients with Chronic Low Back Pain 2022-04-03 anticipated 20 Complete https://irct.ir/trial/62291 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individuals are Randomly Divided into Two Groups, Which Will be Done Using Randomization Sequence through Randomization.com and Balanced Block Randomization Method. The Size of the Blocks is 4. Also, for Allocation Concealment, Sealed and Numbered Envelopes are Used, Which are Provided to the Participants by the Secretary, Blinding description: Patients are Randomly Divided into Two Groups of Real Treatment and Unreal(Placebo) Treatment Who do not Know the Type of their Group. The Information Obtained from the Evaluation of Patients is Categorized by another Person and the Analyst is not Aware of the Grouping of Information. N/A Chronic Low Back Pain due to Radiculopathy. Intervention 1: Intervention group: Sensory-motor training in three stages of static, dynamic, functional and real tDCS in time for 4 weeks and 3 times a week (12 sessions), tDCS model neurostim2 model of Medina Teb Gostar company, electrode size 2*4cm, An active electrode (anode) on the M1 region, which according to the international system is 10-20 according to C3 or C4, An active electrode (anode) on the S1 region, which is 2 cm behind the C3 or C4, Reference electrodes (cathode) on the forehead and directly above the eyebrows, Device with an intensity of 1.5 mA and for 20 minutes, The beginning of the current, a period of 10 seconds ramping up, The end of the current, a period of 10 seconds ramping down. Intervention 2: Control group: Sensory-motor exercises in three stages of static, dynamic and functional and tDCS as sham for 4 weeks and 3 times a week (12 sessions), tDCS for 20 minutes: placement of electrodes as intervention group, Device turned on and The intensity increases to the point that the patient feels a tingling sensation, but this feeling will be only for 10 seconds. 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 more information.
public Dr.Roya Khanmohammdi
School of Rehabilitation, Corner of Safi Alishah St, Pich e Shemiran, Engheleb Eslami Ave
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 rkhanmohammadi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr.Roya Khanmohammdi
School of Rehabilitation, Corner of Safi Alishah St, Pich e Shemiran, Engheleb Eslami Ave
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 rkhanmohammadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Suffering from LBP for more than 6 (m) or Experience LBP in 3 courses for more than 1 (w) in past 12 (w) Unilateral Radicular Pain Secondary to Disc Herniation L4/L5 and L5/S1 Diagnosed with MRI Being Positive of Slump Test or Straight Leg Raise Test or Lasegues’s Test Pain from Anterior Lateral Part of Leg to Back Area of the Leg Associated with L4/L5 Dermatome to the Posterior Part of the Leg and Heel and Lateral Part of the Foot Absence of any History of Brain Tumor, Brain Injury or Brain Stroke Absence of any History of Spondylolysis, Spondylolisthesis and Spinal Cord Fractures Absence of any History of Neurological Disease such as Parkinson, Cerebellum Disorders or Alzheimer Absence of any History of Scratches or Cut on the Scalp Average Pain Score ≥ 4 Oswestry Disability Index > 4 Mini Mental Status Examination ≥ 24 No Pregnancy Absence of the History of Seizure No Implantation or Pulse Maker Absence of the History of Dermal Infection Age Range: 20 year - 50 year 20 years 50 years Both Participant Dissatisfaction with the Continuation of the Program Being Absent for more than 2 Sessions or for 3 Times during the whole Procedure If the Patient is under a Special Therapeutic Program M54.5 Low back pain Rehabilitation Rehabilitation Intervention group: Sensory-motor training in three stages of static, dynamic, functional and real tDCS in time for 4 weeks and 3 times a week (12 sessions), tDCS model neurostim2 model of Medina Teb Gostar company, electrode size 2*4cm, An active electrode (anode) on the M1 region, which according to the international system is 10-20 according to C3 or C4, An active electrode (anode) on the S1 region, which is 2 cm behind the C3 or C4, Reference electrodes (cathode) on the forehead and directly above the eyebrows, Device with an intensity of 1.5 mA and for 20 minutes, The beginning of the current, a period of 10 seconds ramping up, The end of the current, a period of 10 seconds ramping down Control group: Sensory-motor exercises in three stages of static, dynamic and functional and tDCS as sham for 4 weeks and 3 times a week (12 sessions), tDCS for 20 minutes: placement of electrodes as intervention group, Device turned on and The intensity increases to the point that the patient feels a tingling sensation, but this feeling will be only for 10 seconds. Mean normalized iEMG of the ipsilateral transversus abdominis, multifidus, and gluteus medius in the four time windows (APA1, APA2, APA1, and CPA2). Timepoint: APA1 : -250 to -100 milliseconds, APA2 : -100 to +50 milliseconds, CPA1 : +50 to +200 milliseconds, CPA2 : +200 to +350 milliseconds. Method of measurement: Electromyography. Mean normalized iEMG of the contralateral transversus abdominis, multifidus, and gluteus medius in four time windows (APA1, APA2, CPA1, and CPA2). Timepoint: APA1 : -250 to -100 milliseconds, APA2 : -100 to +50 milliseconds, CPA1 : +50 to +200 milliseconds, CPA2 : +200 to +350 milliseconds. Method of measurement: Electromyography. Mean onset latency of the ipsilateral transversus abdominis, multifidus, and gluteus medius. Timepoint: The time interval between perturbations (time 0) and the time of onset of muscle activity. Method of measurement: Electromyography. Mean onset latency of the contralateral transversus abdominis, multifidus and gluteus medius. Timepoint: The time interval between perturbations (time 0) and the time of onset of muscle activity. Method of measurement: Electromyography. Tehran University of Medical Science Approved 2022-02-23 Ethics committee of School of Nursing, Midwifery and Rehabilitation Tehran University of Medical Sci Unit 6, No. 20, First Soleinami Ally, West Safa Ave., Imam Hossein Sq., Tehran Town Tehran Tehran Iran (Islamic Republic of)