Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-01 @ 12:44 PM
Study NCT ID:
NCT03604068
Status:
UNKNOWN
Last Update Posted:
2018-07-27
First Post:
2018-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulsed Short Wave Therapy In Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Use', 'timeFrame': 'Data collected daily for 7 Days', 'description': 'Quantify the use of analgesic medications during 7 days of postoperative recovery.'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Analogue Pain', 'timeFrame': 'Data collected for 7 Days', 'description': 'The visual analog scale (VAS) has been used extensively for rating pain intensity in previous studies. Postoperative pain will be measured daily over a 7 day recovery period'}, {'measure': 'Time to patient Patient Mobility', 'timeFrame': '2 Days', 'description': 'The benefits of mobility outlined in current nursing textbooks indicate that "Early ambulation is the most significant general nursing measure to prevent postoperative complications". There the time in hours after the c-section operation when the patient becomes mobile(walking) will be used recorded.'}, {'measure': 'Would Closure at Day 7, Wound Complications', 'timeFrame': '7 Days', 'description': 'presence of edema, erythema,hematoma, and exudate from the surgical wound on the seventh postoperative day that could impair woundhealing process'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Caesarean section'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '32871021', 'type': 'DERIVED', 'citation': 'Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following Cesarean section. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.', 'detailedDescription': 'Pain is ranked highest among undesirable clinical outcomes associated with caesarean section therefore postoperative pain relief following a cesarean section is extremely important to optimize maternal and neonate well being. Multimodial analgesics are effective in reducing postoperative pain but analgesia is still not optimized. Opiate based analgesics are effective but having troubling side effects. Addition of non-drug pain therapies hold promise in improving postoperative recovery while potentially allowing for reduced use of drug based analgesics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily\n* Performed using spinal anesthesia\n* ASA I (Normal healthy patients) and II (Patients with mild systemic disease) (as defined by the American Society of Anesthesiologists Physical Status Classification system)\n* PARA 0000, 1, 2, 3 \\[i.e. First, Second, or Third C-Section)\n* At term pregnancy (\\>38 weeks)\n* BMI \\<35\n* Age between 18 - 50 years\n\nExclusion Criteria:\n\n* Longitudinal surgical incision\n* Placental abnormalities noted\n* Time of extraction of the fetus \\>10 min from cutaneous incision\n* Blood loss during surgery of \\>800 ml\n* Any of the conditions not considered in inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03604068', 'briefTitle': 'Pulsed Short Wave Therapy In Cesarean Section', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioElectronics Corporation'}, 'officialTitle': 'Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section', 'orgStudyIdInfo': {'id': 'PRO180401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Group', 'description': 'Patients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as an active RecoveryRx Pulsed Short Wave Therapy device.', 'interventionNames': ['Device: RecoveryRx']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Patients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as a sham RecoveryRx Pulsed Short Wave Therapy device.', 'interventionNames': ['Device: Sham RecoveryRx']}], 'interventions': [{'name': 'RecoveryRx', 'type': 'DEVICE', 'otherNames': ['pulsed shortwave therapy'], 'description': 'A pulsed shortwave therapy medical device', 'armGroupLabels': ['Active Group']}, {'name': 'Sham RecoveryRx', 'type': 'DEVICE', 'otherNames': ['Sham pulsed shortwave therapy'], 'description': 'A sham pulsed shortwave therapy medical device', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tripoli', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'Omar Tabbouche, Pharm D', 'role': 'CONTACT', 'email': 'omartabbouche@gmail.com', 'phone': '+9613433032'}, {'name': 'Moustafa Chaaban, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Haykal hospital', 'geoPoint': {'lat': 34.43352, 'lon': 35.84415}}, {'city': 'Tripoli', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'Mahmoud Maassarani, Ph.D', 'role': 'CONTACT', 'email': 'M.maassarani@outlook.fr', 'phone': '96179156547'}], 'facility': 'New Mazloum Hospital', 'geoPoint': {'lat': 34.43352, 'lon': 35.84415}}], 'centralContacts': [{'name': 'Mahmoud Maassarani, Ph.D', 'role': 'CONTACT', 'email': 'M.maassarani@outlook.fr', 'phone': '79156547'}, {'name': 'Omar Tabbouche, Pharma D', 'role': 'CONTACT', 'email': 'omartabbouche@gmail.com', 'phone': '03433032'}], 'overallOfficials': [{'name': 'Moustafa Chaaban, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haykal hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioElectronics Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}