Assessing Spinal Pain With an Artificial Intelligence-assisted Whole Body Electrical Stimulation Device

Amasya University78 enrolled

Overview

The goal of this observational study is to investigate the correlation between self-reported pain and the measurements obtained using an artificial intelligence-assisted whole-body electrical stimulation device (StimaWELL 120MTRS system) in individuals with chronic back pain. This study is designed as an exploratory, cross-sectional study. After obtaining written and verbal informed consent, 200 patients with back pain will be asked about their age, sex, height, weight, and duration of back pain. Pain location and intensity will be assessed by one of the investigators using a body diagram and the Numerical Pain Rating Scale (NPRS). In addition, the patients will be evaluated by another investigator using the StimaWELL 120MTRS device, and using the dolorimeter for the pressure pain threshold (PPT). PPT will be assessed at four bilateral points: the upper trapezius, the lower trapezius, 5 cm lateral to the spinous process of the L3 vertebra, and 2 cm cranial to the posterior superior iliac spine. To achieve 80% power at a 5% significance level, assuming a medium effect size, estimated minimum sample size is calculated as 158 participants. Accordingly, the target sample size is set at 200 participants. Pearson's or Spearman's correlation coefficient will be used to determine the relationship between pain values measured by the artificial intelligence-assisted device and patient-reported pain scores (0-10) or pressure pain threshold. To assess the relationships among the three continuous variables obtained in this study-patient-reported pain scores (0-10), device-measured pain values, and pressure pain threshold-repeated-measures ANOVA or the Friedman test will be used to compare their means.

Study Type

OBSERVATIONAL

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Experiencing back pain for more than three months * Experiencing recurrent back pain over the last week * Not having used analgesic or muscle relaxant medications in the last week * Aged between 18 and 60 years * Diagnosed with chronic low back pain by a medical doctor * Literate and able to cooperate with study procedures * Willing to participate in the study Exclusion Criteria: * Having neurological, inflammatory, radiculopathy, vertebral fracture, or similar conditions * Experiencing acute-onset pain * Being pregnant or at risk of pregnancy * Having a psychiatric diagnosis and currently taking medication * Having a skin disease or lesion in the area where electrodes will be applied * Currently undergoing physical therapy * Having vestibular, auditory, or cognitive impairments * Possessing an electronic implant * Having a cardiac arrhythmia * Having a coronary or carotid stent * Being diagnosed with epilepsy * Having severe osteoporosis of the spine

Outcomes

Primary Outcomes

Pain intensity measured by the StimaWELL 120MTRS system

The StimaWELL® EMS device is a high-tech modulated low-frequency, 12-channel, mid-frequency stimulation device. The output of the calibration process will be recorded as data to use in the analysis.

Time frame: baseline, one time

Pressure pain threshold

PPT will be assessed using a dolorimeter at four bilateral points (upper trapezius, lower trapezius, 5 cm lateral to L3 spinous process, and 2 cm cranial to the posterior superior iliac spine).

Time frame: baseline, pre-procedure

Patient-reported pain

Participants will be asked to indicate the location of their back pain experienced over the last week on a body diagram, which shows the regions where the electrodes will be placed in a faint outline. For each marked region, participants will be asked to rate their pain intensity using the Numerical Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent greater pain intensity.