Trials / Not Yet Recruiting
Not Yet RecruitingNCT07014761
The Influence of Central Sensitization in Endometriosis Disease
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
Endometriosis diseases include endometriosis and adenomyosis. Researchers will include 200 or more patients with endometriosis diseases; collect relevant clinical data such as age, BMI, educational level, history of other diseases, surgical history, smoking and drinking history, pregnancy and childbirth history, pain duration, preoperative CA125 level, hemoglobin, surgical methods (laparotomy / laparoscopy), endometriosis stage, endometriosis location, baseline (preoperative), 1, 3, and 6-month follow-up CSI scores, dysmenorrhea scores, chronic pelvic pain scores, dyspareunia scores, dyschezia scores, back pain scores, to explore the role of central sensitization in postoperative pain of patients with adenomyosis, that is, the relationship between central sensitization and postoperative pain outcomes (chronic pelvic pain, dyspareunia, dyschezia, back pain); evaluate whether the baseline CSI score can predict the severity of postoperative pain; and explore the pain relief of different medications after lesion resection in patients with endometriosis.
Detailed description
Endometriosis and adenomyosis are included in endometriotic diseases. Endometrial tissue appears outside the uterine is called endometriosis. Adenomyosis is a common gynecological disease in reproductive-aged women. Its characteristic is that endometrial glands and stroma invade the uterine myometrium, accompanied by the proliferation of surrounding smooth muscle cells. 20.9% to 34% of reproductive-aged women have adenomyosis detected by ultrasound examination. Most patients with endometriotic diseases will experience various forms of pain, such as dysmenorrhea, dyspareunia, chronic pelvic pain (CPP) , dyschezia, or back pain, etc. Surgical treatment (such as lesion resection, hysterectomy) is still a common method for treating endometriotic diseases. However, some patients still have persistent pain after surgery. The mechanism of central sensitization (CS) may explain why about 30% of endometriosis patients have persistent CPP after traditional surgical treatment. Previous study indicates that almost half of endometriosis patients (42%) have CS, and CS is independently associated with moderate to severe chronic pelvic pain, and the score of the Central Sensitization Inventory (CSI) at the baseline before surgery is significantly correlated with persistent CPP after surgery. Therefore, it is reasonable to speculate that central sensitization may also be a potential cause of persistent pain after adenomyosis surgery. However, there is currently no relevant study indicating whether central sensitization plays a role in persistent pain after hysterectomy in adenomyosis patients, nor is there any relevant study indicating the pain relief of different medications after lesion resection in endometriosis patients. In this study, researchers will include 200 or more patients with endometriosis diseases; collect relevant clinical data such as age, BMI, educational level, history of other diseases, surgical history, smoking and drinking history, pregnancy and childbirth history, pain duration, preoperative CA125 level, hemoglobin, surgical methods (laparotomy / laparoscopy), endometriosis stage, endometriosis location, baseline (preoperative), 1, 3, and 6-month follow-up CSI scores, dysmenorrhea scores, CPP scores, dyspareunia scores, dyschezia scores, back pain scores. By applying appropriate statistical methods, such as the Mann-Whitney U test or Kruskal-Wallis test for continuous variables, and the Pearson χ2 test for categorical variables, researchers will explore the role of central sensitization in pain after hysterectomy in adenomyosis patients, explore the pain relief of different medications after lesion resection in endometriosis patients, and provide new ideas for postoperative pain management.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Intervention: Observational Cohort | No Intervention |
Timeline
- Start date
- 2025-06-10
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
- First posted
- 2025-06-11
- Last updated
- 2025-06-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07014761. Inclusion in this directory is not an endorsement.