The Influence of Central Sensitization in Endometriosis Disease

NCT07014761 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2025-195-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Adenomatosis

Keywords

central sensitization;; endometriosis;; adenomyosis

Outcome Measures

Primary Outcomes (1)

• central sensitization inventory score

  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

  pre-operation；1, 3, 6 months after surgery

Secondary Outcomes (5)

• dysmenorrhea scores

  pre-operation；1, 3, 6 months after surgery

• chronic pelvic pain scores

  pre-operation；1, 3, 6 months after surgery

• dyspareunia scores

  pre-operation；1, 3, 6 months after surgery

• dyschezia scores

  pre-operation；1, 3, 6 months after surgery

• back pain scores

  pre-operation；1, 3, 6 months after surgery

Study Arms (2)

CS group

CS group（CSI score ≥40 ）

Other: No Intervention: Observational Cohort

no CS group

no CS group (CSI score \<40).

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No Intervention

CS group; no CS group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We will include 200 or more patients with endometriosis diseases; these patients are admitted to the gynaecological ward of Sun Yat-sen Memorial Hospital from March 2025 to March 2027; aged 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

Related Publications (4)

• Harada T, Taniguchi F, Guo SW, Choi YM, Biberoglu KO, Tsai SS, Alborzi S, Al-Jefout M, Chalermchokcharoenkit A, Sison-Aguilar AG, Fong YF, Senanayake H, Popov A, Hestiantoro A, Kaufman Y. The Asian Society of Endometriosis and Adenomyosis guidelines for managing adenomyosis. Reprod Med Biol. 2023 Sep 10;22(1):e12535. doi: 10.1002/rmb2.12535. eCollection 2023 Jan-Dec.

  PMID: 37701076 BACKGROUND

• Raimondo D, Raffone A, Renzulli F, Sanna G, Raspollini A, Bertoldo L, Maletta M, Lenzi J, Rovero G, Travaglino A, Mollo A, Seracchioli R, Casadio P. Prevalence and Risk Factors of Central Sensitization in Women with Endometriosis. J Minim Invasive Gynecol. 2023 Jan;30(1):73-80.e1. doi: 10.1016/j.jmig.2022.10.007. Epub 2022 Oct 29.

  PMID: 36441085 BACKGROUND

• Orr NL, Huang AJ, Liu YD, Noga H, Bedaiwy MA, Williams C, Allaire C, Yong PJ. Association of Central Sensitization Inventory Scores With Pain Outcomes After Endometriosis Surgery. JAMA Netw Open. 2023 Feb 1;6(2):e230780. doi: 10.1001/jamanetworkopen.2023.0780.

  PMID: 36848090 BACKGROUND

• Orr NL, Wahl KJ, Lisonek M, Joannou A, Noga H, Albert A, Bedaiwy MA, Williams C, Allaire C, Yong PJ. Central sensitization inventory in endometriosis. Pain. 2022 Feb 1;163(2):e234-e245. doi: 10.1097/j.pain.0000000000002351.

  PMID: 34030173 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Adenomyosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Diseases

Study Officials

• Yingchen Wu, Doctor

  中山大学孙逸仙纪念医院

  STUDY DIRECTOR

Central Study Contacts

Yingchen Wu, Doctor

CONTACT

+8613560185927; wuych28@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: June 11, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-04

Locations

CN (1)