Multichannel Neuromuscular Electrical Stimulation With Core Exercise for Chronic Low Back Pain (NCT07760142) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multichannel Neuromuscular Electrical Stimulation With Core Exercise for Chronic Low Back Pain
Turkey (Türkiye)45 participantsStarted 2026-08-15
Plain-language summary
Chronic non-specific low back pain is a common musculoskeletal condition that can adversely affect daily activities, functional capacity, sleep, and quality of life. Exercise therapy is a key component of conservative management, and core exercises are used to improve trunk control and the coordinated function of the abdominal, lumbar, and pelvic musculature. Neuromuscular electrical stimulation may be added to exercise to facilitate muscle activation and support pain management; however, the additional clinical benefit of different multichannel stimulation programs remains uncertain.
This three-arm randomized controlled trial evaluates the effects of two multichannel neuromuscular electrical stimulation programs added to a standardized core exercise program in adults with chronic non-specific low back pain. Forty-five participants are allocated in a 1:1:1 ratio to (1) core exercise plus a lumbar strengthening stimulation program, (2) core exercise plus a muscle relaxation stimulation program, or (3) core exercise alone. Treatment is delivered twice weekly for six weeks (12 sessions). In the two stimulation groups, StimaWELL 120MTRS therapy is applied for 30 minutes at 40 °C. Outcomes are assessed at baseline and at week 6. The primary outcome is low back pain intensity measured with a 100-mm Visual Analog Scale. Secondary outcomes are disability, patient-specific functional status, quality of life, and insomnia severity.
Who can participate
Age range
18 Years – 55 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:
* Aged 18 to 55 years.
* Chronic non-specific low back pain lasting at least three months.
* Low back pain not attributable to a specific trauma, infection, tumor, fracture, rheumatologic disease, or serious neurological disorder.
* Pain intensity meeting the protocol threshold stated as VAS \>=3. \[TEYIT - because the outcome VAS is a 100-mm scale, clarify whether the intended eligibility threshold is \>=30 mm (equivalent to 3/10) rather than \>=3 mm.\]
* Physical and cognitive ability to perform the core exercise program.
* Willingness to attend two treatment sessions per week for six weeks (12 sessions total).
* Voluntary participation and provision of written informed consent.
Exclusion Criteria:
* Age younger than 18 years or older than 55 years.
* Low back pain due to disc herniation, spinal stenosis, fracture, tumor, infection, or inflammatory disease.
* Nerve root involvement, marked sensory loss, or muscle weakness.
* Previous lumbar spine surgery.
* Pacemaker or other electronic implant; pregnancy; epilepsy; or active cancer.
* Open wound or skin disease in the treatment area.
* Physical therapy for low back pain within the previous month or continuation of another low back pain treatment during the study period.
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
Change in low back pain intensity (100-mm Visual Analog Scale)
Timeframe: Baseline (week 0) and at the end of the six-week treatment program (week 6)