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IRCT20151228025732N46 IRCT 2019-11-27 Semnan University of Medical Sciences Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety 2019-06-16 anticipated 66 Complete https://irct.ir/trial/42932 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used, Blinding description: Study participants and evaluators are unaware of the allocation of study groups. N/A Chronic low back pain. Intervention 1: Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex is performed for patients. Intervention 2: Intervention group 2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex is performed for patients. Intervention 3: Control group: Based on the treatment protocol, placebo stimulation is applied for patients. Yes - There is a plan to make this available What will be shared: - When: - To whom: Only available to scholars working in academic institutions. Conditions: In case of relevant studies. Where to obtain: Fatemeh Ehsani. Neuromuscular Rehabilitation Research Center, Ghods Blvd. +98 9191310755 How to obtain: - Comments:
public Mona Masoudi
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 masoudi.m94@yahoo.com Semnan University of Medical Sciences scientific Fatemeh Ehsani
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 fatemehehsani59@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) 20-45 years old; Right-handed patients; Having pain-related anxiety score more than 30, based on Pain Anxiety Symptoms Scale (PASS) Suffering from chronic LBP (for more than six weeks or recurrent LBP with at least three episodes lasted more than one week over the past 12 months) A pain score less than 3 out of 10 on a visual analog scale (VAS) on the testing day 20 years 45 years Both Any history of neurological diseases, such as Parkinson’s Disease, Alzheimer Reporting any history of psychological illnesses Presence of any signs of radiculopathy or root lumbar spinal cord involvement Structural deformities in the spine or the lower extremities such as scoliosis, kyphosis, or lordosis Any abnormalities in the vestibular system Cerebellar disorders M54.5 Low back pain Rehabilitation Rehabilitation Rehabilitation Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex is performed for patients. Intervention group 2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex is performed for patients. Control group: Based on the treatment protocol, placebo stimulation is applied for patients. Static and dynamic balance evaluation ( in static and 4,7 level of dynamic condition; with both feet under open and closed eyes conditions during a 30 seconds trial). Timepoint: Before and immediately ,48 hours and one week after intervention. Method of measurement: Biodex Balance System (BBS) (302-950 model, Biodex Medical Systems, Inc. 20, New York, USA). Error rate (number of errors/number of auditory signals(during 30 seconds test-7 trial)) during the auditory stroop task in dual take test. Timepoint: Before and immediately ,48 hours and one week after intervention. Method of measurement: Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software. Reaction time during the auditory stroop task in dual take test (the interval between the two consecutive stimuli will be randomized (2,000 ms to 3,000 ms). All reactions with response delays longer than 3,500 ms will be discarded). Timepoint: Before and immediately ,48 hours and one week after intervention. Method of measurement: Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software. Semnan University of Medical Sciences Approved 2019-06-16 Ethics Committee National Institute for Medical Research Development No. 2, Besat Street, West Fatemi Street, Tehran Tehran Tehran Iran (Islamic Republic of)