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

Overview

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.

Design and setting This is a prospective, three-arm, parallel-group, assessor-blinded randomized controlled trial conducted at the Semiha Atas Timurtas Private Health Professional Services Unit in Cizre, Sirnak, Turkey. Institutional permission for the study site has been obtained. Participants Adults aged 18-55 years with chronic non-specific low back pain lasting at least three months are screened for eligibility. Eligible participants provide written informed consent before study procedures. Randomization and masking Participants are randomized in a 1:1:1 ratio to one of three treatment groups. Participants and the treating physiotherapist cannot be blinded because of the nature of the interventions. Outcome assessments are performed by a physiotherapist who is unaware of group allocation. \[DOLDURULACAK - random sequence generation and allocation concealment method, if available.\] Interventions All groups receive the same standardized core exercise program for six weeks, two sessions per week (12 sessions total). \[DOLDURULACAK - exact core exercises, sets/repetitions, session duration, and progression criteria.\] Group 1 additionally receives the StimaWELL 120MTRS lumbar strengthening program for 30 minutes at 40 °C during each treatment session. Group 2 additionally receives the StimaWELL 120MTRS muscle relaxation program for 30 minutes at 40 °C during each treatment session. Group 3 receives the core exercise program alone and does not receive StimaWELL 120MTRS treatment. Outcome assessment Assessments are conducted before treatment (baseline/week 0) and after completion of the six-week program (week 6). Low back pain intensity is measured with a 100-mm Visual Analog Scale. Secondary outcomes include the Oswestry Disability Index, Patient-Specific Functional Scale, WHOQOL-BREF Turkish version, and Insomnia Severity Index. Statistical analysis The planned sample size is 45 participants (15 per group). The sample-size calculation used G\*Power 3.1.9 with an effect size of 0.25, alpha of 0.05, and power of 0.80, yielding a minimum required sample of 42; the target was increased to 45 to permit equal allocation. Group, time, and group-by-time interaction will be evaluated using a two-way mixed-design analysis of variance, with statistical significance set at p \< 0.05.