Clinical Observation on the Efficacy of Acupoint Force Therapy Devices in the Intervention of Chronic Pelvic Pain

Chronic pelvic pain (CPP) is defined as non-cyclic pain localized in the pelvic region, primarily involving the lower abdomen and lumbosacral area, persisting for more than 6 months. In 2020, the American College of Obstetricians and Gynecologists (ACOG) consensus classified the etiologies of CPP into three major categories: organ diseases, neuromusculoskeletal abnormalities, and psychosocial factors. CPP is a challenging condition estimated to affect 15%-26% of the female population worldwide. Both patients and clinicians often feel frustrated by the limited treatment options available. Furthermore, chronic pelvic pain frequently overlaps with non-pelvic pain conditions (such as fibromyalgia and migraines) as well as non-painful comorbidities (including sleep disorders, mood disorders, and cognitive dysfunction), thereby exacerbating pain severity and leading to functional impairment. A wide array of clinical therapeutic regimens is available, consisting of pharmacotherapy, physical therapy, cognitive-behavioral interventions, and surgery tailored to specific patient populations. Nevertheless, current therapeutic strategies are hampered by inconsistent efficacy and substantial clinical difficulties, stemming from multifactorial etiologies, poor long-term medication adherence coupled with severe adverse effects, as well as the tendency of the condition to persist and recur frequently. Therefore, there is a clinical need for safer, more effective treatment regimens suitable for long-term intervention.

Acupoint massage achieves meridian regulation and analgesic effects through manual stimulation; it is non-invasive, safer, and more acceptable to patients. Nevertheless, traditional manual acupoint massage is similarly constrained by practitioner experience variability, difficulties in standardizing pressure intensity, and substantial time and labor demands on medical staff, making it difficult to achieve stable, quantifiable, and long-term sustainable treatment requirements. Therefore, intelligent technology-based acupoint mechanical stimulation devices capable of precise control over stimulation intensity, frequency, and duration provide a new technological pathway for the sustained and standardized management of chronic pain.

EMMA is a non-invasive acupoint mechanical stimulation device designed for standardized surface intervention. It measures patients' muscle hardness through sensors and 3D vision, identifies pressure points, and provides precise acupoint stimulation to help patients relieve pain and release tension. Our team participated in a study led by Professor Claudia Witt's research group on the effectiveness of app-based acupoint acupressure therapy for women with menstrual pain. In that study, 221 women were divided into an acupoint pressure group and a usual care group, receiving acupressure intervention over 6 menstrual cycles (6 acupoints, 1 minute per acupoint, continuous pressure for 5 days before menstruation). The results showed that the average pain intensity in the third menstrual cycle was significantly lower in the acupressure group compared to the usual care group, with significant differences observed by the sixth cycle. These findings indicate that acupoint pressure can effectively reduce lower abdominal pain during menstruation, providing a theoretical basis for the conduct of this study.

Accordingly, based on preliminary research findings, this project adopts the EMMA acupoint mechanical therapy device for patient treatment, with the objective of evaluating the efficacy and safety of this device in managing chronic pelvic pain. Improvements in patients' symptoms will be assessed via changes in outcome measures including the Visual Analogue Scale (VAS) for pain.

The present study is a prospective,single-center, single-arm, pre-post control clinical trial design with a 2-week study duration. The interventions to be tested are EMMA Massage Therapy(3 times/week for a total of 6 sessions over 2 weeks). Participants will be enrolled at at Peking University Third Hospital, Beijing China.

The design of this study is compliant with the Consolidated Standards of Reporting Trials (CONSORT) guidelines and with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement 2013(Table 1). The study protocol has been approved by the Regional Ethical Review Board of Peking University Third Hospital, China. Approval Number: ID: M20260476.

CCP is characterized by pain and tenderness in the lower abdomen and lumbosacral region. Pathologically, CPP involves chronic inflammation and adhesions of pelvic organs, persistent myofascial tension in the pelvic floor muscles, and a hyperactive state of pain transmission pathways due to central sensitization; these three factors interact synergistically, leading to chronic and diffuse pain. Therefore, treatment requires simultaneous intervention at both peripheral and central levels. From the perspective of Traditional Chinese Medicine Meridian theory, the lower abdomen falls under the jurisdiction of the Ren Meridian, while the lumbosacral region is governed by the Bladder Meridian and Du Meridian-the distribution of CPP pain closely corresponds to the pathways of these meridians. Based on the above, our specific plan is as follows:

①Back acupoint massage (30 minutes) Based on the pathway of the Foot Taiyang Bladder Meridian on the back, the treatment duration is 30 minutes. The massage pressure is set at 30N as the baseline, taking into account the patient's tolerance.

②Abdominal acupoint and tender point massage Based on meridian-disease correlations and expert consensus, we selected Zhongwan (CV12), bilateral Tianshu (ST25), bilateral Guilai (ST29), Guanyuan (CV4), and relevant tender points (Ashi points) for massage in a clockwise sequence. The massage pressure is set at 30 N as the baseline, adjusted according to patient tolerance. And the treatment duration per acupoint is 1 minute as the baseline. Both the pressure and duration may be adjusted according to the patient's individual condition, and additional tender points may be included as appropriate based on the participant's presentation.