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NCT Number: NCT07014761

The Influence of Central Sensitization in Endometriosis Disease

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location contact

Yingchen Wu, Doctor

CONTACT

[email protected]

+8613560185927

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention

Primary outcomes

  1. central sensitization inventory score

    Time frame: pre-operation;1, 3, 6 months after surgery

    The 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 outcomes

  1. dysmenorrhea scores

    Time frame: pre-operation;1, 3, 6 months after surgery

    the pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)

  2. chronic pelvic pain scores

    Time frame: pre-operation;1, 3, 6 months after surgery

    the pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)

  3. dyspareunia scores

    Time frame: pre-operation;1, 3, 6 months after surgery

    the pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)

  4. dyschezia scores

    Time frame: pre-operation;1, 3, 6 months after surgery

    the pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)

  5. back pain scores

    Time frame: pre-operation;1, 3, 6 months after surgery

    the pain scores were rated on an 11-point numeric rating scale (0-10, with 0 indicating no pain and 10 indicating worst pain imaginable)

Study contacts

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

Yingchen Wu, Doctor

CONTACT

[email protected]

+8613560185927

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

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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