Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-28 @ 4:49 AM
Study NCT ID:
NCT06296303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Change from Baseline pain and function at 6 weeks', 'description': 'Visual analogue scale'}, {'measure': 'Disability', 'timeFrame': 'Change from Baseline pain and function at 6 weeks', 'description': 'Oswestry disability index'}, {'measure': 'Sciatic nerve cross sectional area', 'timeFrame': 'Change from Baseline pain and function at 6 weeks', 'description': 'Diagnostic Ultrasound'}], 'secondaryOutcomes': [{'measure': 'H-reflex amplitude', 'timeFrame': 'Change from Baseline pain and function at 6 weeks', 'description': 'by EMG unit'}, {'measure': 'H-reflex side-to-side amplitude (H/H) ratio', 'timeFrame': 'Change from Baseline pain and function at 6 weeks', 'description': 'by EMG unit'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Radiculopathy']}, 'descriptionModule': {'briefSummary': 'Purposes of the study\n\nTo investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients', 'detailedDescription': 'Patients will be randomized into either pulsed magnetic therapy group or phonophoresis group. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age ranges from 20 -45\n* Unilateral chronic lumbosacral radiculopathy\n* Intervertebral disc herniation confirmed by MRI\n* one of the following :\n\n 1. H- reflex amplitude side to side difference 0.67 in absence of latency difference.\n 2. H- reflex amplitude side to side difference smaller than 0.5 in p of latency difference.\n\n 3 - Side to side H- reflex latency difference more than 1 msec. 4- Prolonged H-reflex latency more than 30 msec.\n\nExclusion Criteria:\n\n* Systematic disease\n* Lumbar canal stenosis\n* Pervious surgeries\n* Scoliosis\n* Kyphosis\n* Spinal fracture\n* Bilateral symptoms\n* Steroid injection'}, 'identificationModule': {'nctId': 'NCT06296303', 'briefTitle': 'Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Pulsed Magnetic Therapy Versus Phonophoresis on Sciatic Nerve Cross Section Measured by Ultrasonography in Discogenic Lumbar Radiculopathy Patients', 'orgStudyIdInfo': {'id': 'MBH24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulsed electromagnetic therapy group', 'description': 'Patients in this group will receive Pulsed electromagnetic therapy + Conventional physical therapy', 'interventionNames': ['Other: Pulsed electromagnetic therapy', 'Other: Conventional physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Ultrasound phonophoresis group', 'description': 'Patients in this group will receive Ultrasound phonophoresis + Conventional physical therapy', 'interventionNames': ['Other: Ultrasound phonophoresis', 'Other: Conventional physical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients in this group will receive Conventional physical therapy', 'interventionNames': ['Other: Conventional physical therapy']}], 'interventions': [{'name': 'Pulsed electromagnetic therapy', 'type': 'OTHER', 'description': 'Pulsed etromagnetic therapy (1000 gauss) on sciatic nerve in gluteal fold. ( 30 min )', 'armGroupLabels': ['Pulsed electromagnetic therapy group']}, {'name': 'Ultrasound phonophoresis', 'type': 'OTHER', 'description': 'Phonophoresis using dexamethasone and topical diclofenac sodium gel on sciatic nerve in subgluteal fold and mid thigh', 'armGroupLabels': ['Ultrasound phonophoresis group']}, {'name': 'Conventional physical therapy', 'type': 'OTHER', 'description': 'Conventional physical therapy consisting of\n\n1. IF current on lumbar spine. (15 min )\n2. Hotpack on lumbar spine . (15 min )\n3. Neurodynamic mobilization .\n4. Mobilization and manipulation for lumbar spine.\n5. Exercises', 'armGroupLabels': ['Control group', 'Pulsed electromagnetic therapy group', 'Ultrasound phonophoresis group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Badr Hassanein, MSc', 'role': 'CONTACT', 'email': '10722016464064@pg.cu.edu.eg', 'phone': '+20 114 225 3884'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Mohamed Badr Hassanein', 'investigatorAffiliation': 'Cairo University'}}}}