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

Amasya University

Status: Enrolling

Conditions: Chronic Back Pain

Study type: Observational

Funder types: Other

Identifiers

NCT07244237

14082025

Details and patient eligibility

About

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. The main question it aims to answer is: Is there any correlation between the pain intensity assessed with StimaWELL 120MTRS system, dolorimeter and self-report in adults with chronic back pain? The patients who have back pain for the duration longer than 3 months and have been eximaned by a medical doctor will be assessed with StimaWELL 120MTRS system, dolorimeter, and will be asked to rate their pain intensity in Numerical Pain Rating Scale.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Patients with chronic back pain