Using acupoint application to improve pelvic inflammatory disease and chronic pelvic pain

A Randomized Controlled Trial on the Clinical Efficacy and Safety of Warm Meridians and Relieve Pain Plaster in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain (Cold Dampness Stasis Type).

This study is testing if a new type of pain-relief patch can help people with pelvic inflammatory disease and chronic pelvic pain feel better compared to regular patches and a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Beijing Hospital of Integrated Traditional Chinese and Western Medicine (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06360965 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of improved warm meridians and relieve pain plaster compared to traditional plaster and a placebo in treating the sequelae of pelvic inflammatory disease and chronic pelvic pain. The study involves 102 patients who will be randomly assigned to one of three groups, with acupoint patches applied to the navel. The therapeutic effects will be assessed after two menstrual cycles, and follow-up will occur one cycle post-treatment to monitor any adverse events. The goal is to provide a safe and effective treatment option for a condition that currently lacks effective Western medical interventions.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-50 with diagnosed sequelae of pelvic inflammatory disease and chronic pelvic pain.

Not a fit: Patients with fertility requirements, acute gynecological conditions, or chronic pelvic pain due to tumors or endometriosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate chronic pelvic pain and improve the quality of life for affected patients.

How similar studies have performed: While this approach is based on traditional practices, similar studies have shown promise in using acupoint applications for pain relief, though this specific methodology may be novel.

Eligibility criteria

Inclusion Criteria:

1. Meets the diagnostic criteria of traditional Chinese and Western medicine for sequelae of pelvic inflammatory disease and chronic pelvic pain;
2. Transvaginal ultrasound examination shows thickening of the fallopian tube wall and fluid accumulation in the lumen, which may be accompanied by pelvic free fluid or fallopian tube ovarian masses;
3. The age range is 18-50 years old, married or with a history of sexual activity;
4. Those with a menstrual cycle of 21-35 days;
5. 4 points ≤ Pain Visual Analog Scale (VAS) \< 7 points;
6. Those who have signed an informed consent form and are willing to receive treatment.

Exclusion Criteria:

1. Female patients who have fertility requirements during pregnancy, lactation, or in the short term;
2. Patients with gynecological diseases such as organic lesions of the reproductive system or gynecological acute abdomen;
3. Chronic pelvic pain caused by gynecological tumors, endometriosis, pelvic congestion syndrome, uterine fibroids, tuberculous pelvic inflammatory disease, and other diseases confirmed through examination;
4. Those with severe diseases such as cardiovascular, cerebrovascular, liver and kidney function, and digestive system;
5. Individuals with mental abnormalities and psychological disorders;
6. Individuals with allergic constitution or known allergies to the drugs and their components used in this experiment;
7. Patients currently participating in clinical trials of other drugs;
8. Other methods of treatment have already been or are currently being carried out, which may affect the indicators observed in this study.

Where this trial is running

Beijing

• Beijing Hospital of Integrated Traditional Chinese and Western Medicine — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Yu Cao, Master — Beijing Hospital of Integrated Traditional Chinese and Western Medicine
• Study coordinator: Yu Cao, Master

Conditions Pelvic Inflammatory Disease; Chronic Pelvic Pain Syndrome; acupoint application; cold dampness stasis type