Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT05326594
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2022-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, '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': 'Disability will be measured via Oswestry Disability Index.'}, {'measure': 'Step length', 'timeFrame': '2 weeks', 'description': 'Step length during gait will be analyzed using observational gait analysis. A greater step length signifies better outcome'}, {'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': 'Disc Height', 'timeFrame': '2 weeks', 'description': 'Disc will be analyzed using Magnetic Resonance Imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Disk Prolapse']}, 'referencesModule': {'references': [{'pmid': '40143467', 'type': 'DERIVED', 'citation': 'Osama M, Naeem A, Tariq S, Mushtaq S, Siddiqi FA, Afridi S. Effects of physical therapy on improving disc height index, postural stability, pain and function in persons with discogenic low back pain. J Pak Med Assoc. 2025 Mar;75(3):378-382. doi: 10.47391/JPMA.20384.'}]}, 'descriptionModule': {'briefSummary': 'Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition, however there is no conclusive evidence regarding the positive effects of conservative physical therapy management in terms of radiological changes and improvement in disc height. For this reason, the current study will not only look into the positive effects of conservative physical therapy on postural stability, pain and function, but also in terms of disc height in persons with discogenic low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and female participants\n* Aged 18-50 years old\n* low back pain intensity less than 80/100mm on visual analogue scale\n* positive centralization phenomenon\n* low signal intensity of IV disc on T2 - weighted MRI\n* high intensity zone towards the posterior aspect of the disc on MRI\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': 'NCT05326594', 'briefTitle': 'Effects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Effects of Physical Therapy on Improving Disc Height Index, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain', 'orgStudyIdInfo': {'id': 'FUI/CTR/2022/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Therapy', 'interventionNames': ['Procedure: Mckenzie Extension Protocol', 'Procedure: Lumbar SNAGs', 'Device: Inferential therapy', 'Procedure: Heat Therapy']}], 'interventions': [{'name': 'Mckenzie Extension Protocol', 'type': 'PROCEDURE', 'description': 'Mckenzie Extension Exercise Protocol will be performed by participants in prone position', 'armGroupLabels': ['Physical Therapy']}, {'name': 'Lumbar SNAGs', 'type': 'PROCEDURE', 'description': 'Lumbar SNAGs will be performed in lumbar flexion and extension in standing Position', 'armGroupLabels': ['Physical Therapy']}, {'name': 'Inferential therapy', 'type': 'DEVICE', 'description': '4 pole inferential therapy in combination with superficial heating for 20 minutes', 'armGroupLabels': ['Physical Therapy']}, {'name': 'Heat Therapy', 'type': 'PROCEDURE', 'description': 'superficial heating for 20 minutes', 'armGroupLabels': ['Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Foundation University Islamabad', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Muhammad Osama, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FUI'}, {'name': 'Aamer Naeem, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FUI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}