# 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

## TL;DR

This study will test how combining brain stimulation and muscle stimulation helps reduce pain and improve movement in people with frozen shoulder.

## Contribution

This is the first trial to compare low and high frequency rTMS combined with NMES for frozen shoulder rehabilitation.

## Key findings

- The trial will assess the effectiveness of rTMS and NMES on pain and mobility in frozen shoulder patients.
- Results may guide the development of more effective rehabilitation methods for frozen shoulder.
- The study will evaluate brain and muscle changes over time using MRI and sEMG.

## Abstract

Repetitive transcranial magnetic stimulation (rTMS) with low and high frequency as well as neuromuscular electrical stimulation (NMES) have been proved efficacy, respectively, on pain and dysfunction of frozen shoulder (FS). Evidence suggests that the integration of central neuromodulation and peripheral stimulation techniques, establishing a closed-loop neural circuitry, yields superior therapeutic outcomes compared to isolated rehabilitation modalities. Therefore, the purpose of this study is to evaluate the clinical effectiveness and neuro-biomechanism of combining rTMS and NMES in alleviating pain and motor deficit of primary FS patients.

This will be an assessor and patients blinded, sham controlled and randomized controlled clinical trial involving a 4-week intervention and a 6-month follow-up. 117 people with FS will be equally allocated to the sham-rTMS + NMES group (Group A), low frequency (LF)-rTMS + NMES group (Group B) and high frequency (HF)-rTMS+ NMES group (Group C) through stratified randomization. Interventions will be provided in 5 sessions per week, with a total of 20 sessions. The primary outcome measurements will be the score of Constant-Murley. The secondary outcome measurements will include polysomnography, quality of life (QOL) by SF-36, muscle biomechanics by surface electromyography (sEMG), motor evoked potential (MEP), brain neuroplasticity by magnetic resonance imaging (MRI). Evaluations will be performed at six time points, including at baseline, 2 weeks and 4 weeks from the start of treatment, and 1 month, 3 months and 6 months following the end of treatment. Two-way analysis of variance with repeated measures will be applied to examine the main effects of the group, the time and group-time interaction effects for all outcomes.

The study will be the first protocol to demonstrate the effectiveness of rTMS with/without NMES for improving shoulder function and pain management after FS and compare the efficacy of LF-rTMS and HF-rTMS. The results of the study may guide the design of more effective treatment methods for FS rehabilitation.

ChiCTR2500098406.