Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
Study NCT ID:
NCT06058806
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Change from Baseline pain at 6 weaks', 'description': 'Visual analog scale (VAS)'}, {'measure': 'Disability', 'timeFrame': 'Change from Baseline Disability at 6 weaks', 'description': 'Roland-Morris Disability Questionnaire (RMDQ)'}, {'measure': 'Soleus H-reflex amplitude', 'timeFrame': 'Change from Baseline Soleus H-reflex amplitude at 6 weaks', 'description': 'by EMG unit'}, {'measure': 'Soleus H-reflex side-to-side amplitude (H/H) ratio', 'timeFrame': 'Change from Baseline Soleus H/H ratio at 6 weaks', 'description': 'by EMG unit'}, {'measure': 'Fractional anisotropy (FA) of the compressed nerve root', 'timeFrame': 'Change from Baseline Fractional anisotropy (FA) ratio at 6 weaks', 'description': 'by MRI examination'}, {'measure': 'Apparent diffusion coefficient (ADC) of the compressed nerve root', 'timeFrame': 'Change from Baseline Apparent diffusion coefficient (ADC) at 6 weaks', 'description': 'by MRI examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbosacral Radiculopathy', 'Lumbar disc herniation'], 'conditions': ['Lumbosacral Radiculopathy']}, 'descriptionModule': {'briefSummary': 'Purposes of the study\n\nTo investigate the effect of Multimodal Physical Therapy on pain, daiablility H-reflex, and Diffusion Tensor Imaging (DTI) Parameters in Patients With Lumbosacral Radiculopathy.', 'detailedDescription': 'Participants will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises. 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* chronic (≥ 3 months) unilateral Lumbosacral Radiculopathy (LSR)\n* The LSR is due to paracentral L4-L5 or L5-S1 Lumbar disc herniation\n* The LSR is confirmed radiologically by MRI\n* The LSR is confirmed clinically by history and physical examination\n* The LSR is confirmed neurophysiological by soleus H-reflex assessment\n* Body mass Index less than 30\n* 20-45 years of age\n\nExclusion Criteria:\n\n* systematic disease\n* Bilateral symptoms\n* Lumbar spinal stenosis\n* previous surgery\n* Steroid injection\n* Spinal fracture\n* Lumbar spinal stenosis\n* Spinal deformity\n* Spinal fracture\n* Radiological evidence of bilateral nerve root encroachmen\n* Evidence of H-reflex amplitude or latency affection on asymptomatic side'}, 'identificationModule': {'nctId': 'NCT06058806', 'briefTitle': 'Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effects of Multimodal Physical Therapy on Pain, Disability, H-reflex, and Diffusion Tensor Imaging Parameters in Patients With Lumbosacral Radiculopathy', 'orgStudyIdInfo': {'id': 'MBH18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal Physical Therapy', 'description': 'Patients in this group will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises.', 'interventionNames': ['Other: Multimodal Physical Therapy']}], 'interventions': [{'name': 'Multimodal Physical Therapy', 'type': 'OTHER', 'otherNames': ['Physical Therapy', 'Physiotherapy'], 'description': 'Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises', 'armGroupLabels': ['Multimodal Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Outpatient clinic, Faculty of Physical Therapy, Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'Mohamed Badr Hassanein', 'investigatorAffiliation': 'Cairo University'}}}}