Effects of rTMS over the contralateral M1 combined with NMES on pain and functional mobility in primary frozen shoulder: study protocol for a 4-week double-blind, randomized, sham-controlled trial.

Researchers are studying a new combination treatment for frozen shoulder, a painful condition that limits shoulder movement. This study will test whether combining brain stimulation (repetitive transcranial magnetic stimulation or rTMS) with muscle electrical stimulation (NMES) can reduce pain and improve shoulder function better than either treatment alone. The trial will involve 117 patients divided into three groups: one receiving sham (placebo) brain stimulation with real muscle stimulation, one receiving low-frequency brain stimulation with muscle stimulation, and one receiving high-frequency brain stimulation with muscle stimulation. Patients will receive 20 treatment sessions over four weeks, five times per week, and will be followed for six months afterward. Researchers will measure shoulder function, sleep quality, quality of life, muscle activity, and brain changes using various tests including MRI scans. This is a study protocol, meaning the research is planned but results are not yet available. The study aims to determine whether combining central nervous system treatment (brain stimulation) with peripheral treatment (muscle stimulation) creates a more effective therapy than traditional approaches. While this study focuses on non-acupuncture interventions, patients with frozen shoulder may also consider acupuncture as part of a comprehensive treatment plan, as it addresses both pain and functional limitations through different mechanisms. If considering acupuncture for frozen shoulder, seek treatment from a licensed acupuncturist with experience in musculoskeletal conditions.

This protocol describes a double-blind, sham-controlled RCT investigating combined repetitive transcranial magnetic stimulation (rTMS) and neuromuscular electrical stimulation (NMES) for primary frozen shoulder. The study will randomize 117 patients into three groups: sham-rTMS+NMES, low-frequency rTMS+NMES, and high-frequency rTMS+NMES, with 20 sessions over four weeks. Primary outcome is the Constant-Murley score; secondary outcomes include polysomnography, SF-36 quality of life, surface EMG, motor evoked potentials, and MRI-assessed neuroplasticity. Assessments occur at baseline, 2 weeks, 4 weeks, and 1, 3, and 6 months post-intervention. This protocol represents the first comparative study of LF-rTMS versus HF-rTMS combined with peripheral stimulation for frozen shoulder, testing the hypothesis that integrated central neuromodulation and peripheral stimulation creates superior therapeutic outcomes through closed-loop neural circuitry. Results may inform multimodal rehabilitation strategies. No efficacy data available as this is a protocol paper.