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

May 8, 2026 updated by: Kübra Okuyucu, Amasya University

Validity of an AI-Supported Whole-Body Electrical Stimulation Device for Spinal Pain Assessment: A Comparison With Self-Reported Pain Scores

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from the eligible and volunteer patients who will visit the healthy living center in study duration.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with chronic back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity measured by the StimaWELL 120MTRS system
Time Frame: baseline, one time
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.
baseline, one time
Pressure pain threshold
Time Frame: baseline, pre-procedure
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).
baseline, pre-procedure
Patient-reported pain
Time Frame: baseline, pre-procedure
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.
baseline, pre-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amasya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

August 15, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14082025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will probably be shared on a reasonable request. But it is not decided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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