Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT07014761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Central Sensitization in Endometriosis Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-21', 'size': 151814, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-11T08:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2025-04-26', 'studyFirstSubmitQcDate': '2025-06-02', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'central sensitization inventory score', 'timeFrame': 'pre-operation；1, 3, 6 months after surgery', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'dysmenorrhea scores', 'timeFrame': 'pre-operation；1, 3, 6 months after surgery', 'description': '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)'}, {'measure': 'chronic pelvic pain scores', 'timeFrame': 'pre-operation；1, 3, 6 months after surgery', 'description': '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)'}, {'measure': 'dyspareunia scores', 'timeFrame': 'pre-operation；1, 3, 6 months after surgery', 'description': '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)'}, {'measure': 'dyschezia scores', 'timeFrame': 'pre-operation；1, 3, 6 months after surgery', 'description': '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)'}, {'measure': 'back pain scores', 'timeFrame': 'pre-operation；1, 3, 6 months after surgery', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['central sensitization;', 'endometriosis;', 'adenomyosis'], 'conditions': ['Endometriosis', 'Adenomatosis']}, 'referencesModule': {'references': [{'pmid': '37701076', 'type': 'BACKGROUND', 'citation': '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': '36441085', 'type': 'BACKGROUND', 'citation': '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': '36848090', 'type': 'BACKGROUND', 'citation': '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': '34030173', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted to the gynaecological ward of Sun Yat-sen Memorial Hospital from March 2025 to March 2027;\n2. Age 18-50 years old;\n3. Endometriosis focus excision or hysterectomy (with or without bilateral salpingo-oophorectomy, with excision of any complicated lesion);\n4. The pathology was adenomyosis or endometriosis.\n\nExclusion Criteria:\n\n1. Postmenopausal (spontaneous or surgical);\n2. Hysterectomy and/or bilateral salpingo-oophorectomy (before baseline)\n3. Lack of CSI or CPP score;\n4. The postoperative follow-up time was less than 6 months.'}, 'identificationModule': {'nctId': 'NCT07014761', 'briefTitle': 'The Influence of Central Sensitization in Endometriosis Disease', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'The Influence of Central Sensitization in Endometriosis Disease', 'orgStudyIdInfo': {'id': 'SYSKY-2025-195-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CS group', 'description': 'CS group（CSI score ≥40 ）', 'interventionNames': ['Other: No Intervention: Observational Cohort']}, {'label': 'no CS group', 'description': 'no CS group (CSI score \\<40).', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['CS group', 'no CS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Yingchen Wu, Doctor', 'role': 'CONTACT', 'email': 'wuych28@mail.sysu.edu.cn', 'phone': '+8613560185927'}], 'facility': 'Sun Yat-sen Memorial Hospital，Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yingchen Wu, Doctor', 'role': 'CONTACT', 'email': 'wuych28@mail.sysu.edu.cn', 'phone': '+8613560185927'}], 'overallOfficials': [{'name': 'Yingchen Wu, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': '中山大学孙逸仙纪念医院'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'No URL available at this time'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}