Effects of cerebral and peripheral electrical stimulation on brain activity in individuals with non-specific chronic low back pain

The aim of this study is to compare the effects of cerebral and peripheral electrical stimulation on brain activity, pain intensity, pain perception, pressure pain threshold, amount of lumbar flexion and functional performance of patients with non-specific chronic low back pain.

This study is a randomized, triple blind clinical trial (patient, test and data analyzer) with three parallel intervention groups. 30 non-specific chronic low back pain patients will be randomly assigned into three treatment groups using covariate adaptive randomization method. Obviously, a code is assigned to each participant to hide the type of intervention.

This is a blinded triple study in which patients do not have any knowledge of the three groups of interventions they are supposed to compare, in addition to the test and analyst of the data, they are unaware of the grouping of patients. Patients with non-specific chronic low back pain (Ahvaz city) will be randomly assigned to three treatment groups at the specialized clinic of Ahvaz Jundishapur rehabilitation faculty. In the first group, the participants receive real peripheral and cerebral stimulation, the second group receives the real cerebral and sham peripheral stimulation and the third group receives real peripheral and sham cerebral stimulation. To stimulate the brain transcranial direct current stimulation device (tDCS), and transcutaneous electrical nerve stimulation device (TENS) will be used to stimulate the peripheral. For sham treatment, device will be placed on the treatment area, but after 30 seconds, the device will be turned off. In total, patients receive 10 sessions of therapy, at a frequency of five times a week, and each session will receive a 30-minute TENS and 20-minute tDCS and the effect of these electrical stimulation investigate immediately at the end of the first session and one day after the tenth session on absolute and relative power of brain activity, pain intensity, pain perception, pressure pain threshold, amount of lumbar flexion and functional ability .In the end, for survival, the treatment results are followed one month after the end of the treatment.

Inclusion criteria: aged 30-50 years, Pain intensity greater than 30 based on 100 mm visual analogue Scale at least six month; Exclusion criteria: a history of non-cured systemic diseases including musculoskeletal, respiratory, cardiovascular, and 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, spondylolysis and spondylolisthesis, history of low back surgery, history of trauma in low back one year before this study, herniated disk with pressure effect on nerve root and pay attention to patient MRI report, current pregnancy, current use of effective medication on brain activity, alcoholism and addiction, use of transcranial direct current stimulation (tDCS ) and transcutaneous electrical nerve stimulation (TENS) in 6 months a go

30 patients with chronic non-specific low back pain will be randomly assigned into 3 treatment groups. The first group receives real transcutaneous electrical nerve stimulation and real transcranial direct current stimulation, the second group receives real transcranial direct current stimulation and sham transcutaneous electrical nerve stimulation and the third group receives real transcutaneous electrical nerve stimulation and sham transcranial direct current stimulation.

Absolute power index based on quantitative Electroencephalography; Relative power index based on quantitative Electroencephalography; Pain intensity based on visual analog scale; Pain perception based on McGill pain questionnaire; Pressure pain threshold based on the number of pressure algometer; Lumbar flexion based on Schober's test; Functional ability based on the score of the oswestry disability questionnaire and Sit-to-Stand and Stand-to-Sit and up and go

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.

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)

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.

One year after publication

Researchers and health professionals

Research and clinical use.

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