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

Design and setting This is a prospective, three‐arm, parallel‐group, assessor‐blindedrandomized controlled trial conducted at the Semiha Atas Timurtas Private HealthProfessional Services Unit in Cizre, Sirnak, Turkey. Institutional permission for thestudy site has been obtained.Participants Adults aged 18‐55 years with chronic non‐specific low back pain lasting atleast three months are screened for eligibility. Eligible participants provide writteninformed consent before study procedures.Randomization and masking Participants are randomized in a 1:1:1 ratio to one of threetreatment groups. Participants and the treating physiotherapist cannot be blinded becauseof the nature of the interventions. Outcome assessments are performed by aphysiotherapist who is unaware of group allocation. [DOLDURULACAK ‐ random sequencegeneration and allocation concealment method, if available.]Interventions All groups receive the same standardized core exercise program for sixweeks, two sessions per week (12 sessions total). [DOLDURULACAK ‐ exact core exercises,sets/repetitions, session duration, and progression criteria.] Group 1 additionallyreceives the StimaWELL 120MTRS lumbar strengthening program for 30 minutes at 40 °Cduring each treatment session.Group 2 additionally receives the StimaWELL 120MTRS muscle relaxation program for 30minutes at 40 °C during each treatment session.Group 3 receives the core exercise program alone and does not receive StimaWELL 120MTRStreatment.Outcome assessment Assessments are conducted before treatment (baseline/week 0) and aftercompletion of the six‐week program (week 6). Low back pain intensity is measured with a100‐mm Visual Analog Scale. Secondary outcomes include the Oswestry Disability Index,Patient‐Specific Functional Scale, WHOQOL‐BREF Turkish version, and Insomnia SeverityIndex.Statistical analysis The planned sample size is 45 participants (15 per group). Thesample‐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 to45 to permit equal allocation. Group, time, and group‐by‐time interaction will beevaluated using a two‐way mixed‐design analysis of variance, with statisticalsignificance set at p < 0.05.