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).
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Hospital of Integrated Traditional Chinese and Western Medicine | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Hospital of Integrated Traditional Chinese and Western Medicine |
China,
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) . |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05868668 -
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
|
N/A | |
Completed |
NCT05546203 -
Trigger Point Treatment in Chronic Pelvic Pain
|
N/A | |
Recruiting |
NCT05926752 -
Photobiomodulation for Myofascial Pelvic Pain
|
N/A | |
Completed |
NCT00775281 -
Changes in Inflammatory and Contractile Protein Expression in Patients With Painful Bladder Syndrome/IC.
|
N/A | |
Recruiting |
NCT06209346 -
Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
|
N/A | |
Terminated |
NCT01879930 -
Chronic Bladder Pain Syndrome in Women: Can Doxycycline Help? A Prospective Study
|
Phase 4 | |
Completed |
NCT00688506 -
Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome
|
N/A | |
Completed |
NCT00922012 -
Efficacy of Electromagnetic Stimulation Therapy for Chronic Prostatitis and Chronic Pelvic Pain Syndrome
|
N/A | |
Completed |
NCT00434343 -
Physical Therapy Trial for Pelvic Pain
|
N/A | |
Recruiting |
NCT03641807 -
Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
|
N/A | |
Completed |
NCT00710073 -
Sono-Electro-Magnetic Therapy for Refractory Chronic Pelvic Pain Syndrome
|
N/A | |
Completed |
NCT01843946 -
Clinical Efficacy of Roxithromycin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
|
N/A | |
Completed |
NCT04549389 -
The Ideal LiST Session Frequency Protocol for CPPS Treatment
|
N/A | |
Recruiting |
NCT06161805 -
Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study
|
Phase 3 | |
Not yet recruiting |
NCT06168058 -
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
|
N/A | |
Completed |
NCT01738464 -
Microbiomes of Pelvic Pain
|
||
Completed |
NCT01391338 -
A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)
|
Phase 2 | |
Not yet recruiting |
NCT06445790 -
Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women
|
N/A | |
Recruiting |
NCT05754190 -
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
|
||
Completed |
NCT06038773 -
Social and Clinical Aspects of Pelvic Pain in Turkey
|