[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657640":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":22,"studyPopulation":13,"armGroups":23,"interventions":30,"overallOfficials":13,"centralContacts":36,"locations":13,"responsibleParty":43,"collaborators":13,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":13,"eligibilityCriteria":50,"healthyVolunteers":47,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":13,"studyType":57,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":13,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":13},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"The primary outcome is the Visual Analogue Scale (VAS) at week 2 (end of treatment).A scale of 0-10 represents different degrees of pain, with 0 representing \"no pain\" and 10 representing \"unbearable pain.\"","The primary outcome is the Visual Analogue Scale (VAS) at week 2 (end of treatment).A scale of 0-10 represents different degrees of pain, with 0 representing \"no pain\" and 10 representing \"unbearable pain.\" Patients mark the position corresponding to their pain severity on the scale; higher scores indicate more severe pain.","We will administer VAS scale assessments at four time point: basline, After 1 week of treatment, 2 weeks of treatment and follow-up 2 weeks after last treatment : All baseline measures are repeated measures.",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NA","SINGLE_GROUP","The present study is a prospective,single-center, single-arm, pre-post control clinical trial design with a 2-week study duration.","TREATMENT",{"masking":20,"maskingDescription":21,"whoMasked":13},"NONE","The present study is a prospective,single-center, single-arm, pre-post control clinical trial conducted at Peking University Third Hospital. This study aims to evaluate the efficacy and safety of the EMMA intelligent acupoint mechanical therapy device - a non-invasive, standardized intervention capable of precise control over stimulation parameters - for the treatment of chronic pelvic pain, providing a novel technological approach for sustained and standardized chronic pain management.","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.\n\nAcupoint 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.\n\nEMMA 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.\n\nAccordingly, 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.\n\nThe 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\u002Fweek for a total of 6 sessions over 2 weeks). Participants will be enrolled at at Peking University Third Hospital, Beijing China.\n\nThe 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.\n\nCCP 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:\n\n①Back 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.\n\n②Abdominal 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.",[24],{"label":25,"type":26,"description":27,"interventionNames":28},"All participants will recept EMMA treatment in EMMA treatment","EXPERIMENTAL","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.Participants will recive 3 times\u002Fweek for a total of 6 sessions over 2 weeks.",[29],"Device: EMMA Robot-assisted Tuina",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":13},"DEVICE","EMMA Robot-assisted Tuina","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.The specific acupoints are illustrated in the figure below.\n\n②Abdominal 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.",[25],[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Haolin Zhang, Doctor","CONTACT","15611963539","Ext.86","zoe@bjmu.edu.cn",{"type":44,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100657640","clinical-observation-on-the-efficacy-of-acupoint-force-therapy-devices-in-the-intervention-of-chronic-pelvic-pain-100657640",false,"NCT07841171","Clinical Observation on the Efficacy of Acupoint Force Therapy Devices in the Intervention of Chronic Pelvic Pain","Inclusion Criteria:\n\n1. Meet the diagnostic criteria for chronic pelvic pain;\n2. Disease duration greater than 6 months;\n3. Female patients aged 20-50 years;\n4. Married or unmarried with history of sexual activity;\n5. Not concurrently participating in other clinical studies;\n6. Voluntarily participate in this trial and provide signed informed consent. Note: Patients must meet all 6 criteria above to be enrolled in this study.\n\nExclusion Criteria:\n\n1. Altered consciousness, inability to cooperate and complete the study, or presence of psychiatric disorders;\n2. Concomitant severe diseases of the cardiovascular, cerebrovascular, hepatic, renal, urinary, digestive, or reproductive systems;\n3. Concomitant severe spine-related conditions, such as spinal fracture, spinal infection, severe osteoporosis, spondylolisthesis, or spinal instability;\n4. Presence of skin lesions, infections, ulcers, or severe dermatological conditions in the treatment area;\n5. Pregnant, planning pregnancy, or lactating women;\n6. Abdominal, pelvic, lumbar, or pelvic-related surgery or invasive procedures within the past 12 months;\n7. Currently participating in other clinical trials. Note: Individuals meeting any one of the above criteria shall be excluded.","FEMALE","20 Years","50 Years",{"count":55,"type":56},20,"ESTIMATED","INTERVENTIONAL",[15],"The present study is a prospective,single-center, single-arm, pre-post control clinical trial conducted at Peking University Third Hospital. 20 participants will be recruited into CCP group,Clinical outcomes will be evaluated at baseline, one week and two weeks after treatment and two weeks follow-up after treatment termination.\n\nThe primary outcome measure is the Visual Analogue Scale (VAS) pain score before and after treatment. Secondary outcomes include Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Numerical Rating Scale (NRS), SF-36 Health Survey, Short-form McGill Pain Questionnaire (SF-MPQ), adverse event incidence rate, and analgesic medication use frequency.Adverse events will be assessed at every visit. Both the CRF and web-based electronic database, REDCap (edc.bjmu.edu.cn), will be used to manage individual participant data by two data entry personnel independently. SPSS V.25.0 statistical software was used for analysis. This report describes the study design of the clinical trial.",[61],"Chronic Pelvic Pain",[63,64,61,65],"EMMA","the Visual Analogue Scale (VAS) pain score","pre-post control clinical","NOT_YET_RECRUITING","2026-09-19",{"date":69,"type":70},"2026-09-25","ACTUAL",{"date":72,"type":56},"2026-09-30",{"date":74,"type":56},"2027-06-30",{"name":5,"class":6}]