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NCT Number: NCT06360965

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets the diagnostic criteria of traditional Chinese and Western medicine for sequelae of pelvic inflammatory disease and chronic pelvic pain;
  • 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;
  • The age range is 18-50 years old, married or with a history of sexual activity;
  • Those with a menstrual cycle of 21-35 days;
  • 4 points ≤ Pain Visual Analog Scale (VAS) < 7 points;
  • Those who have signed an informed consent form and are willing to receive treatment.

Exclusion criteria

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

Treatment and study plan

Improved warm meridians and relieve pain plaster

Drug

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

Drug

The treatment course is the same as the improved warm meridians and relieve pain plaster group.

Placebo plaster

Drug

The treatment course is the same as the improved warm meridians and relieve pain plaster group.

Primary outcomes

  1. Main symptoms (lower abdominal pain) improvement level (visual analogue scale)

    Time frame: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks).

    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.

Secondary outcomes

  1. TCM syndrome score scale

    Time frame: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

    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.

  2. Local physical sign rating scale

    Time frame: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

    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.

  3. Pelvic masses and fluid accumulation

    Time frame: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

    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.

  4. EuroQol Five Dimensions Questionnaire

    Time frame: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

    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.

  5. Recurrence of abdominal pain during 1-month menstrual cycle was followed up.

    Time frame: the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Cao, Master

CONTACT

[email protected]

13811911690

Sponsors and collaborators

Lead sponsor

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Other

Registry information

Official study 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).

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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