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Recruiting NCT07760142

NCT07760142 Multichannel Neuromuscular Electrical Stimulation With Core Exercise for Chronic Low Back Pain

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Clinical Trial Summary
NCT ID NCT07760142
Status Recruiting
Phase
Sponsor Uskudar University
Condition Chronic Low-back Pain
Study Type INTERVENTIONAL
Enrollment 45 participants
Start Date 2026-08-14
Primary Completion 2026-12-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 55 Years
Study Type INTERVENTIONAL
Interventions
Core exercise programStimaWELL 120MTRS - lumbar strengthening programStimaWELL 120MTRS - muscle relaxation program

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 45 participants in total. It began in 2026-08-14 with a primary completion date of 2026-12-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

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.

Contact & Investigator

Central Contact

ömer şevgin

✉ omer.sevgin@uskudar.edu.tr

📞 +905069787535

Principal Investigator

Semiha Ataş Timurtaş

STUDY CHAIR

Üsküdar University

Frequently Asked Questions

Who can join the NCT07760142 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07760142 currently recruiting?

Yes, NCT07760142 is actively recruiting participants. Contact the research team at omer.sevgin@uskudar.edu.tr for enrollment information.

Where is the NCT07760142 trial being conducted?

This trial is being conducted at Şırnak, Turkey (Türkiye).

Who is sponsoring the NCT07760142 clinical trial?

NCT07760142 is sponsored by Uskudar University. The principal investigator is Semiha Ataş Timurtaş at Üsküdar University. The trial plans to enroll 45 participants.

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