Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT04549818
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2020-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-12', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-12', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of intensity of pain', 'timeFrame': 'The outcome will be measured at day 15 postoperatively.', 'description': 'The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age, 18-70\n* Pain localized to the pelvic and perineal region\n* The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer\n* The intensity of pain assessed by VAS (visual analogue pain scale) \\> 7\n* Importantly, the included participants should gain \\> 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root\n\nExclusion Criteria:\n\n* Coagulopathy\n* Infection at site of maneuver\n* Abnormal Psychological behavior that interfere with integrity of obtained data'}, 'identificationModule': {'nctId': 'NCT04549818', 'briefTitle': 'Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?', 'orgStudyIdInfo': {'id': 'SECI2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sacral neuromodulation', 'description': 'Sacral neuromodulation group, will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation', 'interventionNames': ['Device: sacral neuromodulation']}, {'type': 'NO_INTERVENTION', 'label': 'medical therapy', 'description': 'this group will be treated with sustained release morphine tablets for pain control'}], 'interventions': [{'name': 'sacral neuromodulation', 'type': 'DEVICE', 'description': 'Sacral neuromodulation group, N=22 will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation', 'armGroupLabels': ['sacral neuromodulation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesia dep. south egypt cancer institute, El methaque st., assuit city, Egypt', 'investigatorFullName': 'Diab Fuad Hetta', 'investigatorAffiliation': 'Assiut University'}}}}