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Sponsor: Uskudar University
Conditions: Chronic Low-back Pain
Interventions: Core exercise program, StimaWELL 120MTRS - lumbar strengthening program, StimaWELL 120MTRS - muscle relaxation program
Countries: Turkey (Türkiye)
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.
Sex: ALL
Age: 18 Years to 55 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Şırnak, Turkey (Türkiye)