Assessing Spinal Pain With an Artificial Intelligence-assisted Whole Body Electrical Stimulation … (NCT07244237) | Clinical Trial Compass
CompletedNot Applicable
Assessing Spinal Pain With an Artificial Intelligence-assisted Whole Body Electrical Stimulation Device
Turkey (Türkiye)78 participantsStarted 2025-11-15
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity measured by the StimaWELL 120MTRS system