Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT04012034
Status:
UNKNOWN
Last Update Posted:
2021-03-19
First Post:
2019-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With Radiofrequency in Patients With Chronic Pelvic Pain and History of Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D059350', 'term': 'Chronic Pain'}], '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': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2019-05-25', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain: VAS score', 'timeFrame': 'Baseline (Before starting the study)', 'description': 'Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.'}, {'measure': 'Pain: VAS score', 'timeFrame': '1 month after study completion', 'description': 'Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.'}], 'secondaryOutcomes': [{'measure': 'Quality of life: QoL SF-36', 'timeFrame': 'Before starting the study', 'description': 'QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability'}, {'measure': 'Quality of life: QoL SF-36', 'timeFrame': '1 month after study completion', 'description': 'QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability'}, {'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': 'Before starting the study', 'description': 'Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all'}, {'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': '1 month after study completion', 'description': 'Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Chronic Pain', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Managing chronic pelvic pain in patients with a past history of endometriosis might be a challenge for the gynaecologist.\n\nThe objective of this study is to evaluate pelvic pain after treatment with radiofrequency in patients with chronic pelvic pain and surgery for endometriosis.', 'detailedDescription': 'Patients with pelvic chronic pain and a past history of endometriosis without imaging evidence of endometriosis in the present will be enrolled in this study. The main objective of this study is to evaluate improvement of pelvic pain these patients. Moreover, quality of life and sexual function will be also assessed. Patients who are enrolled will come once a week per eight weeks to the hospital to have 30 minutes treatment with radiofrequency. They will be randomised in two groups, one receiving the radiofrequency and the other not (the device will be not give the energy). At the enrollement visit, the SF-36, VAS score, anxiety and depression tests and sexual function tests will be answered the patients. At the end of the treatment, and one month after the end, they will answer the same questionnaires.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic pelvic pain\n* Past surgery for endometriosis\n\nExclusion Criteria:\n\n* Active endometriosis, diagnosed by imaging techniques\n* Presence of other diseases that can cause chronic pelvic pain\n* Contraindication for the radiofrequency use: pregnancy, metallic prothesis'}, 'identificationModule': {'nctId': 'NCT04012034', 'briefTitle': 'Treatment With Radiofrequency in Patients With Chronic Pelvic Pain and History of Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Treatment With Punction and Radiofrequency of Active Trigger Points in Patients With Pelvic Chronic Pain and History of Endometriosis', 'orgStudyIdInfo': {'id': 'RFDP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency A', 'description': 'Treatment with radiofrequency', 'interventionNames': ['Device: Radiofrequency A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Treatment with radiofrequency without energy', 'interventionNames': ['Device: Radiofrequency B']}], 'interventions': [{'name': 'Radiofrequency A', 'type': 'DEVICE', 'description': 'Application of radiofrequency for 30 minutes per week during 8 weeks', 'armGroupLabels': ['Radiofrequency A']}, {'name': 'Radiofrequency B', 'type': 'DEVICE', 'description': 'Application of radiofrequency without energy for 30 minutes per week during 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Francisco Carmona, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It is not intended to share IPD to other researchers since it is the first study of this kind in our setting.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of gynecology department', 'investigatorFullName': 'Francisco Carmona', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}