Multichannel Neuromuscular Electrical Stimulation With Core Exercise for Chronic Low Back Pain

NCT07760142 · tracked via the Priya Life Science Turkey tracker

Sponsor

Uskudar University

Phase

Not applicable

Started

2026-08-14

Last updated

2026-08-18

Condition(s) studied

Chronic Low-back Pain

Investigational drug(s) / intervention(s)

Core exercise programStimaWELL 120MTRS - lumbar strengthening programStimaWELL 120MTRS - muscle relaxation program

Core exercise program: Core Exercise + Multichannel NMES Lumbar Strengthening; Core Exercise + Multichannel NMES Muscle Relaxation; Core Exercise Alone

StimaWELL 120MTRS - lumbar strengthening program: Multichannel neuromuscular electrical stimulation using the StimaWELL 120MTRS lumbar strengthening program, applied for 30 minutes at 40 °C, twice weekly for six weeks (12 sessions), in addition to the core exercise program.

StimaWELL 120MTRS - muscle relaxation program: Multichannel neuromuscular electrical stimulation using the StimaWELL 120MTRS muscle relaxation program, applied for 30 minutes at 40 °C, twice weekly for six weeks (12 sessions), in addition to the core exercise program.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change in low back pain intensity (100-mm Visual Analog Scale) — Baseline (week 0) and at the end of the six-week treatment program (week 6)
Low back pain intensity is assessed using a 100-mm horizontal Visual Analog Scale. Participants mark the point that best represents their average low back pain during the previous seven days, anchored by 0 mm (no pain) and 100 mm (unbearable pain). The distance from the 0-mm anchor to the mark is measured in millimeters. Higher values indicate greater pain intensity.

Trial sites (1)

Facility	City	Region	Status
Semiha Atas Timurtas Private Health Professional Services Unit	Şırnak	Turkey (Türkiye)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07760142 on ClinicalTrials.gov ↗ ← All trials in Turkey