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IRCT20140705018362N3 IRCT 2018-03-13 Ahvaz University of Medical Sciences Effect of cerebral and peripheral electrical stimulation on non-specific chronic low back pain Effects of cerebral and peripheral electrical stimulation on brain activity in individuals with non-specific chronic low back pain 2018-04-02 anticipated 30 Complete https://irct.ir/trial/28964 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The balanced randomization using the covariate adaptive randomization technique described by Taves. First, We will assign a number of participants in each group using sequentially numbered, opaque, sealed envelopes. Then, the Taves method will be used to balance participants in the groups based on the important covariates such as sex and age, Blinding description: The data analyst and the outcome assessor will be blinded to group allocation of each participant.Participants will not be aware of their group allocation ( there is 3 experiment group). N/A Chronic non-specific low back pain. Intervention 1: The intervention group 1: In this group, participants will receive 10 sessions of real cerebral and peripheral electrical stimulation, 5 days a week, for two weeks. The cerebral stimulation will be applied using a transcranial direct current stimulation (2 mA, energy density of 0.057 mA per square centimeter). The peripheral electrical stimulation will be applied using a Transcutaneous electrical nerve stimulation apparatus (100 Hz frequency, a pulse duration of 200 μs, asymmetrical biphasic square wave). TENS current intensity will be regulated according to the patient sensory threshold, characterized as an intense, yet comfortable. In each treatment session, patients will receive 20 min cerebral electrical stimulation, and 30 min peripheral electrical stimulation. Intervention 2: The intervention group 2: Participants will receive real cerebral and sham peripheral stimulation. For sham peripheral stimulation, TENS adjustment will be similar to the group 1. But in this group, 30 sec after adjustment of the intensity of stimulation, the TENS machine will be switched off. Intervention 3: The intervention group 3: Participants will receive sham cerebral and real peripheral stimulation. For sham cerebral stimulation, the cerebral stimulation set up will be similar to the other groups. But after 30 sec the tDCS machine will be switched off. Yes - There is a plan to make this available What will be shared: one year after publication, all of participants data (without identifiers) collected during the trial will be shared The study's protocol will be submitted for publication in an international journal, following registration of the trial in IRCT. The study's protocol will contain statistical analysis plan. We plan to inform Health Care Professionals of our findings by submitting our results for publication in international scientific journals. Furthermore, the results of our research will be shared with researchers at national and international scientific meetings and conferences. When: One year after publication To whom: Researchers and health professionals Conditions: Research and clinical use. Where to obtain: Secure scientific websites and the researchers of the study Scientific website Journals, and search engines such Google Scholars, Research gate, and Pubmed How to obtain: Online access via scientific websites or email to the investigators Comments:
public Fateme Esfandiarpour
School of Rehabilitation Sciencesُ, University Campus, Golestan
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61333743101 esfandiarpour_f@ajums.ac.ir Ahvaz University of Medical Sciences scientific Fateme Esfandiarpour
School of Rehabilitation Sciences, University Pardis, Golestan
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3374 3101 esfandiarpour_f@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Aged 30-50 years A history of non-specific chronic Low Back Pain for at least six months OR a history of three episodes of Low Back Pain in the last year which were associated with activity limitation for more than 3 days or had required medical intervention Pain intensity greater than 30 based on 100 mm visual pain Scale 30 years 50 years Both A history of non-cured systemic diseases including musculoskeletal, respiratory, cardiovascular, hormonal diseases, and malignancies َA history of neurological disorders such as a headache, Seizure, polyneuropathy A history of psychological disorders such as anxiety, depression and phobia Addiction and alcoholism Taking medications that affect brain activity Brain implant Spondylolysis and Spondylolisthesis A history of low back surgery A history of trauma to lower back in the last year Herniated disk with clinical or/and imaging sign of nerve root involvement A history of treatment by transcranial direct current stimulation (tDCS) and/or transcutaneous electrical nerve stimulation (TENS) in the last six months Pregnancy M54.9 Dorsalgia, unspecified Rehabilitation Rehabilitation Rehabilitation The intervention group 1: In this group, participants will receive 10 sessions of real cerebral and peripheral electrical stimulation, 5 days a week, for two weeks. The cerebral stimulation will be applied using a transcranial direct current stimulation (2 mA, energy density of 0.057 mA per square centimeter). The peripheral electrical stimulation will be applied using a Transcutaneous electrical nerve stimulation apparatus (100 Hz frequency, a pulse duration of 200 μs, asymmetrical biphasic square wave). TENS current intensity will be regulated according to the patient sensory threshold, characterized as an intense, yet comfortable. In each treatment session, patients will receive 20 min cerebral electrical stimulation, and 30 min peripheral electrical stimulation. The intervention group 2: Participants will receive real cerebral and sham peripheral stimulation. For sham peripheral stimulation, TENS adjustment will be similar to the group 1. But in this group, 30 sec after adjustment of the intensity of stimulation, the TENS machine will be switched off. The intervention group 3: Participants will receive sham cerebral and real peripheral stimulation. For sham cerebral stimulation, the cerebral stimulation set up will be similar to the other groups. But after 30 sec the tDCS machine will be switched off. Pain Intensity. Timepoint: One day before the treatment, one day, ten days and one month after the treatment. Method of measurement: Visual Analog Scale. Oswestry Disability Index Score. Timepoint: One day before the treatment, one day, ten days and one month after the treatment. Method of measurement: Oswestry Disability Questionnaire. The absolute power of the brain activity. Timepoint: One day before the treatment, one day, ten days and one month after the treatment. Method of measurement: Quantitative electroencephalography. The relative power of the brain activity. Timepoint: One day before the treatment, one day, ten days and one month after the treatment. Method of measurement: Quantitative electroencephalography. Functional Level. Timepoint: One day before the treatment, one day, ten days and one month after the treatment. Method of measurement: Sit-to-Stand and Up and Go tests. Lumbar flexion range of motion. Timepoint: One day before the treatment, and one day, ten days and one month after the treatment. Method of measurement: Schober Test. Pressure Pain Threshold. Timepoint: One day before the treatment, and one day, ten days and one month after the treatment. Method of measurement: An algometry device. Ahvaz University of Medical Sciences Approved 2017-12-20 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Central Office, University Campus, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)