Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-06 @ 11:06 PM
Study NCT ID:
NCT06534593
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-08-02
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral 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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the study will consist of 2 arms.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-02-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Back Pain', 'timeFrame': '2 weeks', 'description': 'Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.'}, {'measure': 'Lumbar Range of Motion', 'timeFrame': '2 weeks', 'description': 'Lumbar Range of Motion will be measured via inclinometer. A higher score signifies good outcome.'}, {'measure': 'Postural Stability', 'timeFrame': '2 weeks', 'description': 'Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.'}, {'measure': 'Lumbar Disability', 'timeFrame': '2 weeks', 'description': 'Lumbar Disability will be measured via Oswestry Disability Index.'}, {'measure': 'Stride length', 'timeFrame': '2 weeks', 'description': 'Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome'}, {'measure': 'Gait Velocity', 'timeFrame': '2 weeks', 'description': 'Velocity during gait will be analyzed using observational gait analysis. A greater gait velocity signifies better outcome'}, {'measure': 'Cadence', 'timeFrame': '2 weeks', 'description': 'Cadence during gait will be analyzed using observational gait analysis, which is number of steps per minute.'}, {'measure': 'Disc height index', 'timeFrame': '2 weeks', 'description': 'Disc height index will be analyzed using Magnetic Resonance Imaging. A greater disc height index signifies better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Herniation, Disc', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The current study aims to determine if physical therapy is significantly superior in improving postural stability, pain and function and disc height index in persons with discogenic low back pain, as compared to the standardized medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and female participants\n* Postero-lateral lumbar disc herniation\n* Aged 18-50 years old\n* Low back pain intensity less than 80/100mm on visual analogue scale or 8/10 on numeric pain rating scale\n* Positive peripheralization and centralization phenomenon\n\nExclusion Criteria:\n\n* Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06534593', 'acronym': 'DISC-RELIEF', 'briefTitle': 'Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation: The DISC-RELIEF Trial', 'orgStudyIdInfo': {'id': 'FUI/CTR/2024/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The Control group will receive standard treatment for the management of discogenic low back pain.', 'interventionNames': ['Other: Standard medical treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'The Physical Therapy group will receive Physical Therapy for the management of discogenic low back pain.', 'interventionNames': ['Device: Lumbar Traction', 'Other: Mckenzie Extension Protocol', 'Device: Interferential Therapy', 'Device: Heat Therapy', 'Other: Sustained Natural Apophyseal Glides (SNAGs)']}], 'interventions': [{'name': 'Standard medical treatment', 'type': 'OTHER', 'description': 'Standard medical treatment', 'armGroupLabels': ['Control Group']}, {'name': 'Lumbar Traction', 'type': 'DEVICE', 'description': 'Lumbar traction using traction table', 'armGroupLabels': ['Experimental Group']}, {'name': 'Mckenzie Extension Protocol', 'type': 'OTHER', 'description': 'Mckenzie Extension Exercises', 'armGroupLabels': ['Experimental Group']}, {'name': 'Interferential Therapy', 'type': 'DEVICE', 'description': 'Interferential Therapy for 20 minutes', 'armGroupLabels': ['Experimental Group']}, {'name': 'Heat Therapy', 'type': 'DEVICE', 'description': 'Heat Therapy for 20 minutes', 'armGroupLabels': ['Experimental Group']}, {'name': 'Sustained Natural Apophyseal Glides (SNAGs)', 'type': 'OTHER', 'description': "3-5 reptations of Mulligan's lumbar extension Sustained Natural Apophyseal Glides (SNAGs)", 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'state': 'Federal', 'country': 'Pakistan', 'facility': 'Foundation University Islamabad', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Muhammad Osama, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foundation University Islamabad'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}