Efficacy of Acupuncture Treatment in the Treatment of Female Myofascial Pelvic Pain Syndrome: A Protocol for a Dual-Center Randomized Controlled Trial.

INTRODUCTION

Myofascial pelvic pain syndrome (MPPS) is a form of chronic pelvic pain (CPP) and pelvic floor dysfunction (PFD), significantly affecting women's physical and mental health. To date, high-quality evidence regarding the efficacy of acupuncture for treating MPPS is lacking. This dual-center randomized controlled trial aims to investigate whether acupuncture is effective for MPPS.

METHODS AND ANALYSIS: A dual-center, parallel, randomized, controlled trial will recruit 180 participants diagnosed with MPPS, who will be randomly allocated (1:1) via computer-generated block randomization to receive either acupuncture treatment or combined electromyographic biofeedback with neuromuscular electrical stimulation (EMG-BF+NMES) for 3 weeks. Primary outcomes include pain intensity (Visual Analog Scale, VAS), myofascial tenderness, pelvic floor muscle function (Modified Oxford Scale), and ultrasound-guided VAS of myofascial trigger points. Secondary outcomes encompass pelvic floor neuromuscular activity (surface electromyography using the Glazer Protocol), Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20), Pelvic Floor Impact Questionnaire-7 (PFIQ-7), Patient Assessment of Constipation Symptoms (PAC-SYM), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), and the Pittsburgh Sleep Quality Index (PSQI). Assessments are scheduled at baseline (T0), immediately after the initial intervention (T1), at 1, 2, 3 weeks post-intervention (T2-T4), and at 3-month post-treatment follow-up (T5). Adverse events will be collected and recorded throughout the treatment period.

CONCLUSION

This trial will evaluate the efficacy and safety of acupuncture for MPPS, compare its therapeutic effects with EMG-BF+NMES, and provide evidence to support the clinical application of acupuncture.

ETHICS AND DISSEMINATION: This study protocol was reviewed and approved by the Ethics Committee of Hangzhou Hospital of Traditional Chinese Medicine (Approval No. 2025LL003). Findings will be disseminated through peer-reviewed publications and academic conferences.

TRIAL REGISTRATION NUMBER: ITMCTR2025000458.