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

NCT07841171 | Not Yet Recruiting

• 1 other identifier: Peking UTH
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Pelvic Pain

Keywords

EMMA; the Visual Analogue Scale (VAS) pain score; Chronic Pelvic Pain; pre-post control clinical

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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/week for a total of 6 sessions over 2 weeks.

Device: EMMA Robot-assisted Tuina

Interventions

EMMA Robot-assisted Tuina DEVICE

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.

All participants will recept EMMA treatment in EMMA treatment

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Not concurrently participating in other clinical studies;
• Voluntarily participate in this trial and provide signed informed consent. Note: Patients must meet all 6 criteria above to be enrolled in this study.

You may not qualify if:

• 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;
• Pregnant, planning pregnancy, or lactating women;
• Abdominal, pelvic, lumbar, or pelvic-related surgery or invasive procedures within the past 12 months;
• Currently participating in other clinical trials. Note: Individuals meeting any one of the above criteria shall be excluded.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Central Study Contacts

Haolin Zhang, Doctor

CONTACT

15611963539; zoe@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The present study is a prospective,single-center, single-arm, pre-post control clinical trial design with a 2-week study duration.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 25, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share