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NOT YET RECRUITING
NCT07841171
NA

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

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

20 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09-30

Completion Date

2027-06-30

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

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. 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.