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.
The 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.
Meet the diagnostic criteria for chronic pelvic pain;
Disease duration greater than 6 months;
Female patients aged 20-50 years;
Married or unmarried with history of sexual activity;
Altered consciousness, inability to cooperate and complete the study, or presence of psychiatric disorders;
Concomitant severe diseases of the cardiovascular, cerebrovascular, hepatic, renal, urinary, digestive, or reproductive systems;
Concomitant severe spine-related conditions, such as spinal fracture, spinal infection, severe osteoporosis, spondylolisthesis, or spinal instability;
Presence of skin lesions, infections, ulcers, or severe dermatological conditions in the treatment area;
Single group
EMMA Robot-assisted Tuina
Device①Back 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. 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.
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.
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