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IRCT20211222053484N1 IRCT 2022-02-16 Tehran University of Medical Sciences Effect of sensorimotor training and brain electrical stimulation on chronic low back pain treatment TDCS Effect of sensorimotor training combined with transcranial electrical stimulation on cortical sensorimotor processing and clinical symptoms in patients with chronic low back pain 2022-03-06 anticipated 28 Complete https://irct.ir/trial/61352 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After completion of the primary assessments, the participants randomly divided in to 2 groups using sequences of randomization via randomization.com and with balanced block randomization method. The size of the blocks is 4. Finally, each participants will placed in one of the two groups randomly and without knowing which group they are placed in. (Real or Sham), Blinding description: In this study, the participants, assessor and analyzer are blinded. The participants will placed in one of the two groups (real or sham) via randomization.com site and they will not know which group they are in.(the participants signed a consent sheet which mentioned that they may placed in one of the two groups without making them knowing). The assessor also doesn't know each participant's group side. The assessor provides all the final information to the third person who saves the participants names as codes. This third person provides all this codes to an analyzer (Therapist). Because of the type of study, blinding of the therapist (researcher) is not possible. N/A Chronic Low Back Pain. Intervention 1: Intervention group: In this group, participants receive sensory-motor training and tDCS in real time for 4 weeks and 3 times a week (12 sessions). To apply electric current, tDCS device model neurostim2 of Medina Teb Gostar company will be used. Before the patient arrives, all instruments including electrodes, normal saline, stimulator, cable, elastic bands and measuring tape are checked to check for safety and the absence of possible damage. The patient sits in a chair. The scalp is then examined for any lesions or irritations, and the researcher asks the participant to report any skin irritations that occurred in the previous session or anything that is part of the exclusion criteria. First, the electrodes are placed in a sponge soaked in sterile salt (NaCl 0.9%) and the skin of the stimulation site is cleaned with alcohol. The size of the electrodes is 5 * 5. Stimulation through two active electrodes (anodal) on the skin The head is applied, an active electrode is placed on the M1 region, which according to the 10-20 International System corresponds to C3 or C4-10, the other active electrode is placed on the S1 region, which is 2 cm behind the C3 Or C4, the reference electrodes are also placed on the forehead and directly above the eyebrows. If the pain is in the center, the active electrode is placed on the dominant hemisphere of the person and the reference on the opposite side is placed in the supraorbital area. At the beginning of the current, we will have a ramping period of up to 10 seconds, at which the current is programmed to the maximum intensity, which is considered to be 2 mA. At the end, we will have a 10-second period of ramping down, which will gradually flow and the device will turn off. In general, according to the size of the active electrode, the average current density below these electrodes is 0.08 mA / cm2. The participant is also informed of the tingling or itching sensation associated with electrical stimulation and is constantly monitored during treatment. Sacroiliac and cervical vertebrae) to facilitate coordinated and automatic movement patterns. Therefore, in all stages of training, it is necessary to position the three areas correctly. To stimulate the soles of the feet (both feet), the exercises are performed barefoot and the soles of each foot are stimulated with a brush. The person is then asked to contract the soleus muscles; So that the inner arch of the foot is increased but the toes are not bent. Initially, for people who are unable to contract the soleus muscles, a strip of Thera-Band can be attached to the sole of the foot to help put the foot in position. During exercise, the sacroiliac joints and cervical vertebrae should also be in a neutral position. The person is also asked to pull the umbilicus slightly inward to facilitate the function of the transverse abdominal muscles. In addition, a person with a chin tuck activates the deep flexor muscles of the neck. In general, the exercises are performed in 3 stages (static, dynamic and functional). Static stage: In this stage, the focus is on pelvic stability by contracting the muscles of the diaphragm, multifidus, pelvic floor and transverse abdominis to perform the movements of the limbs. Provide in the next steps. In other words, this stage is based on the principle of "proximal stability for distal movements". The way to advance in this stage is to stand on two legs, stand on one leg and then stand in a half-step. half-step is a position in which the person brings the trunk forward and keeps the cervical and lumbar vertebrae in a neutral position. Also, the support surface on which the person stands is first rigid and then unstable, such as foam, rocker board and wobble board. The center of gravity is also challenged by the application of perturbations or weight shifts by elastic bands, and the individual must maintain stability. These conditions trigger automatic postural and reflex reactions. Dynamic stage: When a person was able to maintain pelvic stability in the previous stage, he enters the dynamic stage in which the person performs upper and lower limb movements while maintaining pelvic stability. How to advance in this stage is like the static stage of standing on two legs, standing on one leg and then standing in half-step. Also, the support surface on which the person stands is first rigid and then unstable, such as foam, rocker board and wobble board. The center of gravity is challenged with the help of elastic bands and ball throwing. One of the best exercises at this stage is the T-Band Kick. These exercises re-train the feedforward mechanisms. Functional stage: After maintaining the stability of the pelvis while performing upper and lower limb movements, the person enters this stage. At this stage, the person does walking, squatting, lunge, jumping, running and any sport. These exercises will be performed on different levels and different positions. Intensity of exercises: 3 sets with 5 repetitions. Intervention 2: Control group: In this group, participants receive sensory-motor training and sham tDCS for 4 weeks and 3 times a week (12 sessions). tDCS is applied for 20 minutes. In this way, the electrodes are placed like the intervention group. The device is turned on and the intensity is increased until the patient feels a tingling sensation, but this feeling will be only for 15 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 Roya Khanmohammadi
School of Rehabilitation, Corner of Safi Alishah street, Pich e Shemiran, Enghelab street
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5132 rkhanmohammadi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Roya Khanmohammadi
School of Rehabilitation, Corner of Safi Alishah street, Pich e Shemiran, Enghelab street
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5132 rkhanmohammadi@sina.tums.ac.ir Tehran University of Medical Sciences 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 Average pain score ≥ 4 Oswestry disability index ≥ 4 Age range between 20 and 55 years Both genders 20 years 55 years Both Having history of brain tumor, brain injury or brain stroke Having a history of cognitive disorders based on Mini-Mental Status Examination Scale (Mental Status Examination Scale < 24) Having history of spondylolysis and spondylolisthesis Having history of structural disorders or deformities such as scoliosis or kyphosis and hyper lordosis Having history of spinal cord fractures Having history of neurological disease such as Parkinson, Alzheimer or cerebellum disorders Having history of scratches or cut on the scalp Having sensory disorders or lack of sense Having history of seizure Being pregnant Having implantation or pulse maker Having history of dermal infection Having history of surgical procedure Having history of visual disorders Having history of vestibular disorders Having history of depression M51.17 Intervertebral disc disorders with radiculopathy, lumbosacral region Rehabilitation Rehabilitation Intervention group: In this group, participants receive sensory-motor training and tDCS in real time for 4 weeks and 3 times a week (12 sessions). To apply electric current, tDCS device model neurostim2 of Medina Teb Gostar company will be used. Before the patient arrives, all instruments including electrodes, normal saline, stimulator, cable, elastic bands and measuring tape are checked to check for safety and the absence of possible damage. The patient sits in a chair. The scalp is then examined for any lesions or irritations, and the researcher asks the participant to report any skin irritations that occurred in the previous session or anything that is part of the exclusion criteria. First, the electrodes are placed in a sponge soaked in sterile salt (NaCl 0.9%) and the skin of the stimulation site is cleaned with alcohol. The size of the electrodes is 5 * 5. Stimulation through two active electrodes (anodal) on the skin The head is applied, an active electrode is placed on the M1 region, which according to the 10-20 International System corresponds to C3 or C4-10, the other active electrode is placed on the S1 region, which is 2 cm behind the C3 Or C4, the reference electrodes are also placed on the forehead and directly above the eyebrows. If the pain is in the center, the active electrode is placed on the dominant hemisphere of the person and the reference on the opposite side is placed in the supraorbital area. At the beginning of the current, we will have a ramping period of up to 10 seconds, at which the current is programmed to the maximum intensity, which is considered to be 2 mA. At the end, we will have a 10-second period of ramping down, which will gradually flow and the device will turn off. In general, according to the size of the active electrode, the average current density below these electrodes is 0.08 mA / cm2. The participant is also informed of the tingling or itching sensation associated with electrical stimulation and is constantly monitored during treatment. Sacroiliac and cervical vertebrae) to facilitate coordinated and automatic movement patterns. Therefore, in all stages of training, it is necessary to position the three areas correctly. To stimulate the soles of the feet (both feet), the exercises are performed barefoot and the soles of each foot are stimulated with a brush. The person is then asked to contract the soleus muscles; So that the inner arch of the foot is increased but the toes are not bent. Initially, for people who are unable to contract the soleus muscles, a strip of Thera-Band can be attached to the sole of the foot to help put the foot in position. During exercise, the sacroiliac joints and cervical vertebrae should also be in a neutral position. The person is also asked to pull the umbilicus slightly inward to facilitate the function of the transverse abdominal muscles. In addition, a person with a chin tuck activates the deep flexor muscles of the neck. In general, the exercises are performed in 3 stages (static, dynamic and functional). Static stage: In this stage, the focus is on pelvic stability by contracting the muscles of the diaphragm, multifidus, pelvic floor and transverse abdominis to perform the movements of the limbs. Provide in the next steps. In other words, this stage is based on the principle of "proximal stability for distal movements". The way to advance in this stage is to stand on two legs, stand on one leg and then stand in a half-step. half-step is a position in which the person brings the trunk forward and keeps the cervical and lumbar vertebrae in a neutral position. Also, the support surface on which the person stands is first rigid and then unstable, such as foam, rocker board and wobble board. The center of gravity is also challenged by the application of perturbations or weight shifts by elastic bands, and the individual must maintain stability. These conditions trigger automatic postural and reflex reactions. Dynamic stage: When a person was able to maintain pelvic stability in the previous stage, he enters the dynamic stage in which the person performs upper and lower limb movements while maintaining pelvic stability. How to advance in this stage is like the static stage of standing on two legs, standing on one leg and then standing in half-step. Also, the support surface on which the person stands is first rigid and then unstable, such as foam, rocker board and wobble board. The center of gravity is challenged with the help of elastic bands and ball throwing. One of the best exercises at this stage is the T-Band Kick. These exercises re-train the feedforward mechanisms. Functional stage: After maintaining the stability of the pelvis while performing upper and lower limb movements, the person enters this stage. At this stage, the person does walking, squatting, lunge, jumping, running and any sport. These exercises will be performed on different levels and different positions. Intensity of exercises: 3 sets with 5 repetitions. Control group: In this group, participants receive sensory-motor training and sham tDCS for 4 weeks and 3 times a week (12 sessions). tDCS is applied for 20 minutes. In this way, the electrodes are placed like the intervention group. The device is turned on and the intensity is increased until the patient feels a tingling sensation, but this feeling will be only for 15 seconds. Levels below N80 and N150 as the mean of sensory evoked potential amplitude. Timepoint: Before the first session and 48 hours after the 12th session. Method of measurement: By recording sensory evoked potential using EMG / NCV / EP5000 Q. Active motor threshold of multifidus muscle and transverse abdominis / oblique internal. Timepoint: Before the first session and 48 hours after the 12th session. Method of measurement: TMS device model MagPro X100. Active motor evoked potential amplitude of multifidus muscle and transverse abdominis / oblique internal. Timepoint: Before the first session and 48 hours after the 12th session. Method of measurement: TMS device model MagPro X100. Lumbar movement control. Timepoint: Before the first session and 48 hours after the 12th session. Method of measurement: Clinical test (Luomajoki index). Pain. Timepoint: Before the first session and 48 hours after the twelfth session. Method of measurement: By Visual Analogue scale. Disability. Timepoint: Before the first session and 48 hours after the twelfth session. Method of measurement: Through the Oswestry Disability Index questionnaire. Tehran University of Medical Sciences Approved 2021-12-20 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation-Tehran University of Girl's Dormitory Complex of Tehran University of medical sciences, Next to the Masjedonnabi mosque, Above 16th street, North Amir Abaad, North Karegar street, Enghelab Tehran Tehran Iran (Islamic Republic of)