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

NCT07244237 | Recruiting

• 1 other identifier: 14082025
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Back Pain

Keywords

StimaWELL 120MTRS system; Chronic Back Pain; Measurement

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  baseline, pre-procedure

Study Arms (1)

Patients with chronic back pain

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

AMASYAŞAM Sağlıklı Yaşam Merkezi

Amasya, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Aybike Şenel, Research Assistant, PhD

CONTACT

+90 531 583 99 24; aybikesenel@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: November 24, 2025
• Study Start: November 15, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

TU (1)