Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT06102733
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2023-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Pelvic Pain in Females and Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055958', 'term': 'Piriformis Muscle Syndrome'}, {'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2023-10-22', 'studyFirstSubmitQcDate': '2023-10-22', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score, objective measurement using the validated Numeric Pain Rating scale', 'timeFrame': '12 months', 'description': 'Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic pain'], 'conditions': ['Pelvic Pain Syndrome', 'Sacroiliac Disorder', 'Piriformis Syndrome', 'Sacrococcygeal Disorder', 'Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'Pelvic pain is under-reported in healthy adults. Many patients with pelvic pain under-estimate the problem. Chronic pelvic pain can be managed properly, if diagnosed promptly.\n\nThis is a quantitative analysis of prospective clinical data. It evaluates the management of pelvic pain in a cohort population, and analyzes the treatment outcome.', 'detailedDescription': 'Pelvic pain is common, but under-reported in healthy adults. Pelvic pain is reported more commonly in women than in men. Many patients with pelvic pain under-estimate the severity of the problem. Chronic pelvic pain can be managed successfully, if diagnosed properly. Many combinations of multimodal analgesia and rehabilitation therapy may be safe and effective for pelvic pain.\n\nThis study is a quantitative analysis of prospective clinical data. It is an evaluation of the prevalence and management of pelvic pain in a cohort population of chronic pain patients. This is an analysis of multimodal analgesia types, rehabilitation therapy types, treatment outcome, and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with chronic pelvic pain who undergo treatment in pain clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic pelvic pain\n* Patients with sacroiliac pain\n* Patients with inguinal pain\n* Patients with coccygeal pain\n* Patients with piriformis pain\n\nExclusion Criteria:\n\n* Patients with spinal pain\n* Patients who had spine surgery'}, 'identificationModule': {'nctId': 'NCT06102733', 'briefTitle': 'Chronic Pelvic Pain in Females and Males', 'organization': {'class': 'OTHER', 'fullName': 'Salem Anaesthesia Pain Clinic'}, 'officialTitle': 'Chronic Pelvic Pain Management in Female and Male Adult Patients', 'orgStudyIdInfo': {'id': 'SalemAne2018 Pelvic Pain WoMen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult chronic pain patients', 'description': 'Adult chronic pain patients with pelvic, inguinal or sacroiliac pain', 'interventionNames': ['Behavioral: Rehabilitation therapy']}], 'interventions': [{'name': 'Rehabilitation therapy', 'type': 'BEHAVIORAL', 'description': 'Chronic pain rehabilitation therapy', 'armGroupLabels': ['Adult chronic pain patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3S 7J1', 'city': 'Surrey', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olumuyiwa Bamgbade, MD, FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '+17786286600'}, {'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '17786286600'}], 'facility': 'Salem Anaesthesia Pain Clinic', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}], 'centralContacts': [{'name': 'Olumuyiwa Bamgbade, MD,FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '17786286600'}, {'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '17786286600'}], 'overallOfficials': [{'name': 'Olumuyiwa Bamgbade, MD,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salem Anaesthesia Pain Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salem Anaesthesia Pain Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}