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The Influence of Central Sensitization in Endometriosis Disease

The Influence of Central Sensitization in Endometriosis Disease

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07014761
Enrollment
200
Registered
2025-06-11
Start date
2025-06-10
Completion date
2027-03-31
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomatosis, Endometriosis

Keywords

central sensitization;, endometriosis;, adenomyosis

Brief 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.

Interventions

OTHERNo Intervention: Observational Cohort

No Intervention

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. Patients admitted to the gynaecological ward of Sun Yat-sen Memorial Hospital from March 2025 to March 2027; 2. Age 18-50 years old; 3. Endometriosis focus excision or hysterectomy (with or without bilateral salpingo-oophorectomy, with excision of any complicated lesion); 4. The pathology was adenomyosis or endometriosis.

Exclusion criteria

1. Postmenopausal (spontaneous or surgical); 2. Hysterectomy and/or bilateral salpingo-oophorectomy (before baseline) 3. Lack of CSI or CPP score; 4. The postoperative follow-up time was less than 6 months.

Design outcomes

Primary

MeasureTime frameDescription
central sensitization inventory scorepre-operation;1, 3, 6 months after surgeryThe central sensitization inventory score (0 to 100) was obtained by central sensitization inventory questionnaire; a higher score indicates greater symptom severity that may be indirectly related to conditions with underlying central sensitization

Secondary

MeasureTime frameDescription
dysmenorrhea scorespre-operation;1, 3, 6 months after surgerythe pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)
chronic pelvic pain scorespre-operation;1, 3, 6 months after surgerythe pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)
dyspareunia scorespre-operation;1, 3, 6 months after surgerythe pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)
dyschezia scorespre-operation;1, 3, 6 months after surgerythe pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)
back pain scorespre-operation;1, 3, 6 months after surgerythe pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)

Countries

China

Contacts

Primary ContactYingchen Wu, Doctor
wuych28@mail.sysu.edu.cn+8613560185927

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026