Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT06957951
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2025-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of WBV-Supported Core Training on Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single (Outcomes Assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-27', 'studyFirstSubmitDate': '2025-04-27', 'studyFirstSubmitQcDate': '2025-04-27', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity (VAS)', 'timeFrame': '4 weeks', 'description': 'Change in pain scores measured by Visual Analog Scale.'}, {'measure': 'Functional Disability (ODI)', 'timeFrame': '4 weeks', 'description': 'Change in disability scores measured by Oswestry Disability Index.'}, {'measure': 'Quality of Life (SF-36)', 'timeFrame': '4 weeks', 'description': 'Change in quality of life scores'}, {'measure': 'Sleep Quality (PSQI)', 'timeFrame': '4 weeks', 'description': 'Change in sleep quality scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Whole-Body Vibration', 'Core Stabilization Exercises', 'Low Back Pain', 'Sleep Quality', 'Functional Disability'], 'conditions': ['Lumbar Disc Herniation', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': '"This randomized controlled trial investigated the effects of conventional physiotherapy, core stabilization exercises, and WBV-supported core stabilization exercises on pain intensity, functional disability, quality of life, and sleep quality in male patients with lumbar disc herniation without neurological deficits."', 'detailedDescription': '"This study aimed to compare the effects of whole-body vibration (WBV)-supported core exercises, standard core exercises, and conventional physiotherapy on pain, disability, quality of life, and sleep quality among male patients aged 30-50 years with lumbar disc herniation without neurological deficits. Participants were randomly allocated to one of three groups and underwent 12 sessions over 4 weeks. The outcomes assessed were pain (VAS), disability (ODI), quality of life (SF-36), and sleep quality (PSQI)."'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Male gender\n\n * Age between 30 and 50 years\n * Diagnosis of lumbar disc herniation (L4-L5 or L5-S1)\n * No neurological deficits\n\nExclusion Criteria:\n\n* • Prior lumbar surgery\n\n * Severe cardiopulmonary or musculoskeletal disorders\n * Uncontrolled systemic diseases\n * Participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT06957951', 'acronym': 'WBV-LDH', 'briefTitle': 'Effectiveness of WBV-Supported Core Training on Lumbar Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Effectiveness of WBV-Supported Core Training on Pain, Function, and Sleep in Lumbar Disc Herniation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ETU-WBV-LDH-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Physiotherapy', 'description': 'Conventional Physiotherapy including hot pack, TENS, ultrasound, and education.', 'interventionNames': ['Other: Conventional Physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Core Stabilization Exercises', 'description': 'Core stabilization exercises added to conventional physiotherapy.', 'interventionNames': ['Other: Conventional Physiotherapy', 'Behavioral: Core Stabilization Exercises']}, {'type': 'EXPERIMENTAL', 'label': 'WBV-Supported Core Exercises', 'description': 'Participants received conventional physiotherapy combined with core stabilization exercises performed on a whole-body vibration platform (30 Hz, low amplitude \\~2 mm).', 'interventionNames': ['Other: Conventional Physiotherapy', 'Behavioral: WBV-Supported Core Exercises']}], 'interventions': [{'name': 'Conventional Physiotherapy', 'type': 'OTHER', 'description': 'Application of hot packs, TENS (transcutaneous electrical nerve stimulation), therapeutic ultrasound, and posture/activity education for low back pain management.', 'armGroupLabels': ['Conventional Physiotherapy', 'Core Stabilization Exercises', 'WBV-Supported Core Exercises']}, {'name': 'Core Stabilization Exercises', 'type': 'BEHAVIORAL', 'description': 'Supervised core stabilization exercises including planks, bird-dog, and pelvic bridging, targeting trunk muscle strength and stability.', 'armGroupLabels': ['Core Stabilization Exercises']}, {'name': 'WBV-Supported Core Exercises', 'type': 'BEHAVIORAL', 'description': 'Core stabilization exercises performed on a whole-body vibration platform (30 Hz frequency, low amplitude \\~2 mm) during exercise execution to enhance neuromuscular stimulation.', 'armGroupLabels': ['WBV-Supported Core Exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University Medical Faculty Physical Medicine and Rehabilitation Unit', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erzurum Technical University', 'class': 'OTHER'}, {'name': 'Ataturk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Esedullah Akaras', 'investigatorAffiliation': 'Gazi University'}}}}