Table 1 lists the characteristics of the researchers who collaborated in the study. The present study targeted 97 patients with chronic low back pain but no surgical history of low back pain who were referred to the Department of Orthopedics/Anesthesiology and Pain Center at our institution for low back pain after April 2020. The patients were also advised to undergo CBT and PT because they were identified as having no root reason for the low back discomfort based on MRI and neurological symptoms , according the four spinal surgeons. Patients also were unresponsive to traditional orthopedic treatments , including medication (i.e., NSAIDs, gabapentinoids, opioids, and antidepressants) and different block injections. In the cases that were registered the senior doctors confirmed that MRI results were not consistent with symptoms reported by patients during an Pain Center conference. The effectiveness of PT and CBT was assessed using the Brief Scale for Evaluation of mental health issues for Orthopedic Patient (BS-POP) 15 and Locomo 16.. The standard orthopedic treatment was continued throughout the intervention study, but there were no adjustments in the oral medications.
The research was conducted in conformity to the Declaration of Helsinki on Ethical Principles for Medical Research that involves human Subjects. The research protocol was endorsed by Chiba University’s Ethics Committee of Chiba University and all exams were conducted according to these guidelines and guidelines. We explained the details of the research to all patients and obtained written informed consent prior to starting the study.
Research design, neurofeedback and EEG analysis
Figure 1 illustrates a diagram of the timetable of intervention and neurofeedback in this study, as well as that of the system for neurofeedback. The study was a prospective longitudinal study to examine the effects of treatment in every group using EEG and psychosocial variables as indicators. The researcher was not aware about the condition of each participant created an entirely randomized design using random number calculation using identification numbers of patients. After the randomization process, our groups included 20 participants in The Control Group, 18 for the CBT Group (CBTs), 13 cases for those in the Exercise group (PT) 20 cases for the Neurofeedback Training (NFTs) group and 16 of NFTs, 16 for the CBT+NFT Group (CBT-NFTs), and 10 cases for the NFT+PT (PT-NFTs) group.
Each group visited our center each week, receiving the therapeutic intervention of neurofeedback and therapy in a maximum of 8 sessions over a two-month period. In addition, the NFT Group also visited our facility in the initial and eighth weeks and trained for around 10 minutes 3 times a every day from home. The CBT-NFT and PT-NFT group participants received a gadget and completed neurofeedback exercises for about 10 minutes 3 times a day at home. They also took measurements at the time of the consultation.
To perform the measurements and neurofeedback seamlessly without any time lag from the therapeutic intervention, we measured the EEG with a wearable electroencephalograph, then conducted a real-time neurofeedback via a smart-phone application, ALPHA SWITCH ver. 1.3.1 (Mediaseek Inc., Tokyo, Japan, https://www.mediaseek.co.jp/alpha-switch/, available on App Store). Since the app was designed to provide auditory alpha waves neurofeedback when listening to music, and was later adopted as an approach to perform the task while closed with the eyes, it’s feasible to eliminate EEG noise from being contaminated by eye movements, which is a major concern when it comes to EEG measurement.
Neurofeedback and EEG measurements were performed with eyes closed and in a relaxed state in a quiet space. Analysis and recording of EEG along with real-time feedback for the results of analysis were performed using the default settings of ALPHASWITCH in the manner follows. Prior to the feedback session the calibration period was 30 seconds to establish the baseline. After the voltage data from four electrodes were received by Muse2 256 times per second, voltage data was saved in the circular buffer of fixed-length. Then, we utilized DC offsets to the time-series voltage signals (768 arrays) which was then used to calculate the inclination of the spectrum and the percentage of cumulative of noise. To generate power for the Alpha spectrum, we applied the Hilbert transformation by using bandpass filters between 8 and 13 Hz. Then, we performed a logarithmic transform for the mean following the calculation of the size of the arrays of 768. In the case of the values obtained after the transformation, extreme values were rejected by the test of Smirnov-Grubbs. We also determined the mean and the standard deviation of the rejected magnitude values to calculate the magnitude of the alpha waves (alpha power) during the time of calibration.
A feedback session lasting three minutes was held after the calibration The duration of this feedback period varied between 3 and 30 minutes 17.18.19.. So, we planned the measurement at the shortest amount of time of 3 minutes in order to not sleeping throughout the feedback period. Following processing of the data the same manner as the calibration session, and performing a logarithmic transformation based on the magnitude of the alpha wave’s mean, we determined and determined Z score. Z scores in the form of regularized Alpha Power (nAP) by using that mean as well as the mean of the magnitude of the calibration and the standard deviation following the transformation. The nAP index is a measure of magnitude that indicates how alpha is increased through neurofeedback compared to the calibration. We also conducted signal processing and analysis with MATLAB version. 9.10.0 (The Mathworks, Natick, MA).
Feedback was given to the subjects auditorily through earphones , while listening to the relaxing tunes, ” Sunbeams”. In the feedback session white noise was superimposed in a way that the noise level was inversely related to the nAP. In addition to the sigmoid function White noise volume was set at zero, and at the highest when nAP was 2. and –2, respectively. The maximum levels of white noise and music were 60-70 and 60 dB and 60 dB, respectively. Participants were told to reduce the volume of noise by increasing the alpha power as much as is possible. Participants were told to sit in a comfortable position, close their eyes and relax by creating a peaceful image before the neurofeedback session started.
EEG was measured by Muse2 (InteraXon Inc., Toronto, Canada, https://choosemuse.com/muse-2/), a headband-type wearable EEG device that can be attached to one’s forehead with the ends of the band over both ears. While the EEG could be easily monitored without any specific treatment on the forehead or scalp, EEG paste was applied to ensure a precise measurement during the current study. Muse2 contains four active electrodes as well as a reference electrode. Two Active silver chloride electrodes can be found in both sides of the the forehead and two additional active electrodes that are the conductive silicon rubber are situated on the dorsal and lateral and lateral sides of the Auricle in order to stop the formation of artifacts due to eye movements. A reference electrode is situated between two electrodes active in the forehead. Muse2 is built on the 10-10 international system. The electrodes are placed at four points such as TP9 and AF7. the AF8 as well as TP10.The recording rate of the sample was set at 256 Hz and the data recorded was transferred immediately to a tablet (iPad, Apple Inc., San Francisco, CA, USA) via Bluetooth.
We performed the following exam items for all patients regarding discomfort and satisfaction with the treatment at the moment consult: Visual Analogue Scale (VAS) and the Japanese variant of the Oswestry Disability Index (ODI) 20,21 and the Japanese variant of the Hospital Anxiety and Depression Scale (HADS) 22,23 The Japanese versions of the Pain Catastrophic Scale (PCS) 24,25 as well as the Pain Self-Efficacy Questnaire (PSEQ) 26,27.
Analysis of statistics
IBM SPSS Statstics27 (r) (IBM, Armonk, NY) was used to analyse the results. The goal of this research is to examine whether the therapeutic effect could be increased by using alpha wave neurofeedback in conjunction along with CBT and PT in accordance with the study previously conducted. It has also been pointed out that it is important to carry out CBT and PT at an early stage, so statistical analysis is performed on stage (early-chronic/late-chronic) and treatment (Controls, CBTs, PTs, NFTs, CBT-NFTs, PT-NFTs) 2 factors 8 levels ANOVA was performed to examine the low back pain score. We also examined the difference in the mean of psychological and pain scores prior to/after therapy intervention in the different groups. We looked at the mean differences in psychological and pain scores prior to and after the therapeutic intervention in each of the groups through a U-test, with no presumption of normal distribution when considering dispersive deflection. The correlation analysis was also conducted to determine the relation between the intensity of alpha waves and low back scores for pain.
The protocol is described in Table 2. Three psychologists who have more than 10 years of experience performed the CBT. The CBT methods used included psychoeducation as well as cognitive reframing, Relaxation (abdominal breathing , and progressive relaxation of muscles) as well as stress management behavioral activation, and pacing commonly used 28-29. Due to the limited amount of reservations we made, we set the session at 50 minutes per week, which is 8 sessions in total.
The PT program consisted of individual PT with a 50-minute session per week to a maximum of 8 sessions as well as daily home exercises. The exercise prescription included a multimodal program that consisted of exercises to strengthen the muscles of the lower limbs as well as motor control exercises for muscles of the trunk, stretching as well as aerobic exercise 3031 and 32. The workout was scheduled as 40 minutes/session and the intensity of exercise being 12-13 on the Borg scale, in line with what METs are equivalent to between 4-6 33.
After a demonstration of exercise was given to the participants during the first session, every participant did the exercise on their own. A physiotherapist helped the participant to complete the exercises with confidence at home each day for eight weeks, by ensuring that they were using the appropriate techniques, and giving individual instructions when needed. To assess the compliance of the exercise done at home by the participant We used a 5-point Likert scale as well as the following question “How frequently did you complete your exercises in the comfort of the home?”.
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