Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-06-02 @ 7:50 AM
Study NCT ID:
NCT04085068
Status:
UNKNOWN
Last Update Posted:
2022-09-21
First Post:
2019-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-11-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2019-09-08', 'studyFirstSubmitQcDate': '2019-09-08', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body mass index', 'timeFrame': '3 months', 'description': 'BMI in kg/m\\^2'}, {'measure': 'Satisfaction assessed by the VAS', 'timeFrame': '3 months', 'description': "Degrees of menstrual pain will be assessed using a VAS, which was a method of representing subjects' pain on a 10 cm linear scale. Score of 0 meant 'no pain' and 10 meant 'worst pain'. Tomeasure specific symptoms"}, {'measure': 'a pressure-pain threshold', 'timeFrame': '3 months', 'description': 'algometer Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Back Pain']}, 'descriptionModule': {'briefSummary': 'Something must be done in order to release the tension within the dura mater before any lasting correction of the spine can be effected. Each of the cranial nerves is wrapped in a sheath of dura mater. As they exit the cranial vault they are described by Gray\'s Anatomy as having a "dural cuff".'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 women will participate in this study, thirty women diagnosed as having back ar neck pain after surgery.They will be selected from outpatient clinic of obstetrics and Gynaecology department in El-Hosary family health Centre.\n\nAll participants will be given a full explanation of the protocol of the study and informed consent form will be signed from each subject before participating in the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age of the participants will be ranged from 20 to 40 years. Their body mass index will be ranged from 20 to 25 kg/m2. They will have regular menstrual cycle. They will not receive any hormonal therapy or taking any regular drugs.\n\nExclusion Criteria:\n\n* Bone disease. Discogenic state with radiculopathy or not. Systemic disease of musculoskeletal system. Any sensory problems. Previous vertebral fractures. Major spinal structural abnormality.'}, 'identificationModule': {'nctId': 'NCT04085068', 'briefTitle': 'Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery', 'orgStudyIdInfo': {'id': 'P.T.REC/012/00191'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group (group A):', 'description': '15 women take cranioscaral treatment', 'interventionNames': ['Other: cranioscaral treatment']}, {'label': 'control group (group B):', 'description': 'shame group'}], 'interventions': [{'name': 'cranioscaral treatment', 'type': 'OTHER', 'description': 'dural release', 'armGroupLabels': ['Study group (group A):']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lectrure', 'investigatorFullName': 'rovan mohamed saad elbesh', 'investigatorAffiliation': 'Cairo University'}}}}