Ultrasound-guided pulsed radiofrequency versus dry needling for pain management in chronic neck and shoulder myofascial pain syndrome patients at a tertiary hospital in China: a randomised controlled trial protocol.

INTRODUCTION: Myofascial pain syndrome (MPS), especially in the neck and shoulder region, is one of the most common chronic pain disorders worldwide. Dry needling (DN) and pulsed radiofrequency (PRF) are the two effective methods for treating MPS. We aimed to compare the effects of DN and PRF in chronic neck and shoulder MPS patients.

METHODS AND ANALYSIS: This is a prospective, single-centre, randomised, controlled trial in a tertiary hospital. We plan to recruit 108 patients aged 18-70 years who are diagnosed with chronic MPS in the neck, shoulder and upper back regions and randomly allocate them to either the DN or PRF group at a 1:1 ratio. The DN group will receive ultrasound-guided intramuscular and interfascial DN 8-10 times per pain point or until local twitch responses are no longer elicited and 30 min of indwelling. The PRF group will receive ultrasound-guided intramuscular (0.9% saline 2 mL, 42℃, 2 Hz, 2 min) and interfascial (0.9% saline 5 mL, 42℃, 2 Hz, 2 min) PRF. Follow-up will be performed by the research assistant at 0, 1, 3 and 6 months postoperatively. The primary outcome is the postoperative 6-month pain visual analogue score (0-100 mm). Secondary outcomes include pressure pain threshold measured by an algometer, Neck Disability Index, depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7), sleep status (Likert scale) and overall quality of life (36-Item Short Form Survey). Between-group comparisons will be analysed using either a non-parametric test or a mixed effects linear model.

ETHICS AND DISSEMINATION: This study was approved by the medical ethics committee of Peking Union Medical College Hospital (JS-3399). All participants will give written informed consent before participation. The results from this study will be shared at conferences and disseminated in international journals.

TRIAL REGISTRATION NUMBER: NCT05637047, Pre-results.