The Influence of Central Sensitization in Endometriosis Disease
NCT ID: NCT07014761
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2025-06-10
2027-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CS group
CS group(CSI score ≥40 )
No Intervention: Observational Cohort
No Intervention
no CS group
no CS group (CSI score \<40).
No Intervention: Observational Cohort
No Intervention
Interventions
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No Intervention: Observational Cohort
No Intervention
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Principal Investigators
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Yingchen Wu, Doctor
Role: STUDY_DIRECTOR
中山大学孙逸仙纪念医院
Locations
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Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SYSKY-2025-195-02
Identifier Type: -
Identifier Source: org_study_id
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