Clinical Trial of Acupoint Application in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360965
• Other study ID #: Shoufa2024-3-7045
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
• Contact: Yu Cao, Master
• Phone: 13811911690
• Email: howgreenbreeze[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic Pelvic Pain is one of the common gynecological symptoms, characterized by persistent and non periodic pain in the pelvic cavity and surrounding tissues. It is often seen as a sequelae of pelvic inflammatory diseases caused by the failure to receive timely and correct treatment. This study compares the effectiveness of warm meridians and relieve pain plaster in relieving the sequelae of pelvic inflammatory disease and chronic pelvic pain symptoms, and evaluates the safety of improved patches and traditional patches, further promoting it to community grassroots hospitals.

Description:

Chronic Pelvic Pain is one of the common gynecological symptoms, characterized by persistent and non periodic pain in the pelvic cavity and surrounding tissues. It is often seen as a sequelae of pelvic inflammatory diseases caused by the failure to receive timely and correct treatment. Chronic pelvic pain is mainly characterized by lower abdominal or lumbosacral pain, which may be accompanied by increased vaginal discharge. This disease has the characteristics of high incidence rate, long course, lingering, difficult to heal, easy to relapse, etc., which seriously affects women's reproductive health and quality of life, and increases the family and socio-economic burden. At present, there is no effective treatment method in Western medicine for the sequelae of pelvic inflammatory diseases and chronic pelvic pain, mainly targeting the symptoms of patients for treatment. Therefore, this study selected 102 patients with pelvic inflammatory disease sequelae and chronic pelvic pain (cold dampness stasis type) who met the inclusion criteria as the research subjects. They were randomly divided into an improved warm meridians and relieve pain plaster group, a traditional warm meridians and relieve pain plaster group, and a placebo group. Three groups of acupoint patches were applied to the navel, and the therapeutic effect was evaluated after two consecutive menstrual cycles. Follow up was conducted at the end of one menstrual cycle after the treatment, and adverse events during the research process were recorded. Compare the effectiveness of warm meridians and relieve pain plaster in relieving symptoms of this disease, and evaluate the safety of improved patches and traditional patches, further promoting it to community grassroots hospitals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain Syndrome
• Pelvic Inflammatory Disease
• Pelvic Pain

Intervention

Drug:
• Improved warm meridians and relieve pain plaster
Starting from the 1st to 3rd day after the menstrual cycle is clean, apply it 6-8 hours before bedtime every day, with one day off. Apply 10 times per menstrual cycle as one course of treatment, with two consecutive courses of treatment.
• Traditional warm meridians and relieve pain plaster
The treatment course is the same as the improved warm meridians and relieve pain plaster group.
• Placebo plaster
The treatment course is the same as the improved warm meridians and relieve pain plaster group.

Locations

Country	Name	City	State
China	Beijing Hospital of Integrated Traditional Chinese and Western Medicine	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main symptoms (lower abdominal pain) improvement level (visual analogue scale)	Using the Visual Analog Scale (VAS), draw a 10cm thick straight line on the patient record card, with one end indicating no pain and the other end indicating unbearable severe pain. Patients should mark a point on the line based on the degree of lower abdominal pain (bloating or stabbing) they experience. Researchers use a straightedge to measure the straight-line distance from the starting point to the patient's designated point, and express the intensity of pain using the measured numbers. Record the specific mm measured by the patient.	The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks).
Secondary	TCM syndrome score scale	The TCM syndrome score scale consists of three main symptoms and nine secondary symptoms. The main symptoms included abdominal pain, lumbosacral pain and subzonal pain, with scores of 0, 2, 4 and 6 according to the severity. Secondary symptoms include menstrual abdominal pain, fear of cold , loss of appetite, menstrual color, stool, urination, tongue and pulse, etc., tongue and pulse records do not score, other items are given 0, 1, 2, 3 points according to the situation. The higher the total score, the more severe the symptoms.	The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Secondary	Local physical sign rating scale	Local physical sign rating scale included limitation of uterine activity and tenderness, thickening of bilateral appendages and mass, tenderness of bilateral appendages and thickening of uterine-sacral ligament. The score was 0-6. The higher the total score, the more severe the symptoms.	The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Secondary	Pelvic masses and fluid accumulation	Pelvic mass was evaluated according to pelvic ultrasound. The original mass disappeared as disappeared; the original mass volume shrank by more than 2/3 compared with that before treatment as significantly reduced; the original mass volume shrank by 1/3-2/3 compared with that before treatment as reduced; the original mass remained unchanged or increased as unchanged or increased. Pelvic fluid was evaluated according to pelvic ultrasound. The original fluid disappeared as disappeared; the original fluid area reduced by more than 2/3 compared with that before treatment as significantly reduced; the original fluid area reduced by 1/3-2/3 compared with that before treatment as reduced; the original fluid remained unchanged or increased as unchanged or increased.	The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Secondary	EuroQol Five Dimensions Questionnaire	The EQ-5D mainly consists of two parts: the EQ-5D Descriptive System and the EQ-5D Visual Analog Scale . In the description section, the EQ-5D will describe the health status in five dimensions: Mobility, Self care, UsualActivities, Pain/Discomfort, and Anxiety/Depression. The questionnaire requires respondents to choose the most suitable option for themselves in each dimension based on their health status. In the evaluation section, respondents used the Visual Analog Scale (EQ-VAS) to assess their overall health status. EQ-VAS records the self rated health status of respondents on a vertical scale. The scale of the ruler is 0-100, where 0 represents "the worst health state you imagine" and 100 represents "the best health state you imagine". The self-assessment information of the respondents can be used as a quantitative indicator of health outcomes.	The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Secondary	Recurrence of abdominal pain during 1-month menstrual cycle was followed up.	Within 1 menstrual cycle after treatment, patients with the main symptom "pain or tingling of lower abdomen" (VAS score was "0") were followed up, and the end point of follow-up was the recurrence point of the main symptoms. If there was no recurrence in one menstrual cycle after the end of treatment, it was the end point of follow-up.	the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .