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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-15

Study Completion Date

2026-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Back Pain

Keywords

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StimaWELL 120MTRS system Chronic Back Pain Measurement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chronic back pain

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Kübra Okuyucu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AMASYAŞAM Sağlıklı Yaşam Merkezi

Amasya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Aybike Şenel, Research Assistant, PhD

Role: CONTACT

Phone: +90 531 583 99 24

Email: [email protected]

Facility Contacts

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Ahmet Gülünay

Role: primary

Other Identifiers

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14082025

Identifier Type: -

Identifier Source: org_study_id