Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-09 @ 4:15 AM
Study NCT ID:
NCT06521294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2024-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mulligan SNAG Technique in Individuals With Lumbar Intervertebral Disc Protrusion
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnetic Resonance Imaging', 'timeFrame': 'baseline and iafter the intervention (in the 5th week)', 'description': 'to measure protrusion (bigger amount means worse outcome)'}, {'measure': 'Visual Analog Scale-VAS', 'timeFrame': 'baseline and immediately after the intervention (in the 5th week)', 'description': 'to measure pain intensity (min. score is 0 and max. score is 10- higher score means worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index-ODI', 'timeFrame': 'baseline and immediately after the intervention (in the 5th week)', 'description': 'to describe disabilty level resulting from pain (min. score is 0 and max. score is 50- higher score means worse outcome)'}, {'measure': 'Functional Independence Measure- FIM', 'timeFrame': 'baseline and immediately after the intervention (in the 5th week)', 'description': 'to measure independency in daily living activities (min. score is 18 and max score is 156- higger score means better independency in daily living activities)'}, {'measure': 'Tampa Kinesiophobia Scale- TKS', 'timeFrame': 'baseline and immediately after the intervention (in the 5th week)', 'description': 'to measure anxiety-avoidance state (min. score is 17 and max. score is 68- higher score means worse outcome)'}, {'measure': 'One Leg stand Test- OLST', 'timeFrame': 'before and after the intervention (in the 5th week)', 'description': 'to measure static balance ability (min. score 0 and max. score is 60- Higher score means better balance)'}, {'measure': 'Sit-Stand Test-SST', 'timeFrame': 'before and after the intervention (in the 5th week)', 'description': 'to measure lower extremity performance (min. score is 0 and max. score is 30- higher score means better outcome)'}, {'measure': '10-m Walking test and cadance measurement', 'timeFrame': 'before and after the intervention (in the 5th week)', 'description': 'to measure walking speed (in second- higher score means worse outcome) and cadance (number of steps during the test- higher score means better outcome)'}, {'measure': 'Nottingham Health profile-NHP', 'timeFrame': 'before and after the intervention (in the 5th week)', 'description': 'to describe level of quality of life (min. score is 38 and max. score is 3800 - higher score means poor health)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbar disc herniation', 'Mulligan Snag technique', 'Low back pain', 'MRI', 'Physical Functioning', 'Quality of life'], 'conditions': ['Intervertebral Disc Protrusion']}, 'referencesModule': {'references': [{'pmid': '28559749', 'type': 'BACKGROUND', 'citation': 'Hussien HM, Abdel-Raoof NA, Kattabei OM, Ahmed HH. Effect of Mulligan Concept Lumbar SNAG on Chronic Nonspecific Low Back Pain. J Chiropr Med. 2017 Jun;16(2):94-102. doi: 10.1016/j.jcm.2017.01.003. Epub 2017 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to examine the effects of the Mulligan SNAG mobilization technique, applied in addition to conventional physiotherapy on the structure of the intervertebral disc and physical functioning in patients diagnosed with low back pain due to lumbar intervertebral disc protrusion. 38 volunteer patients will participate in the study. The participants will be randomized as an interventional and control gropus.', 'detailedDescription': 'Participants will be treated 3 days a week for 4 weeks. The session duration will be 40-45 minutes. Visual analog scale-VAS, oswestry disability index, magnetic imaging-MRI assessment, functıonal independence scale-FIM, Tampa kinesiophobia scale, one leg stand test, sit-stand test, 10-meter walking test, cadence , Nottingham health profile will be used to assses the participants in the two groups. All participants will be evaluated in the 5th week of the study. The program includes physical therapy session (Hot packed, trans cuteneal electric stimulation, therapeutic ultrasound, and therapautic exercises) and the Mulligan SNAG mobilization technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Being between the ages of 20-60\n2. Those diagnosed with lumbar intervertebral disc heniation (protrusion on L1-L2, L2-L3, L3-L4, L4-L5, L5-S1) at a single level\n3. Those who voluntarily agreed to participate in the study\n\nExclusion Criteria:\n\n* Individuals diagnosed with Lumbar Bulging, Extruded, Sequestered discs\n* Individuals who have undergone lumbar region spinal surgery\n* Individuals with spinal deformity (scoliosis, spondylolisthesis, Ankylosing Spondylitis)\n* Individuals with lumbar stenosis\n* Pregnant women\n* Individuals receiving treatment for malignancy (primary or metastatic tumoral conditions in the lumbar region)\n* Individuals diagnosed with advanced osteoporosis\n* Individuals diagnosed with discitis'}, 'identificationModule': {'nctId': 'NCT06521294', 'briefTitle': 'Mulligan SNAG Technique in Individuals With Lumbar Intervertebral Disc Protrusion', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'Effect of the Mulligan SNAG Technique on Structure of Intervertebral Disc and Physical Functioning in Individuals With Lumbar Intervertebral Disc Protrusion: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'BiruniUniversity34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'SNAG', 'interventionNames': ['Other: Mulligan SNAG mobilization tecnique', 'Other: Conventional Physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Physiotherapy', 'interventionNames': ['Other: Conventional Physiotherapy']}], 'interventions': [{'name': 'Mulligan SNAG mobilization tecnique', 'type': 'OTHER', 'description': 'Mulligan SNAG mobilization tecnique', 'armGroupLabels': ['Group 1']}, {'name': 'Conventional Physiotherapy', 'type': 'OTHER', 'description': 'Conventional Physiotherapy', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'state': 'ZEYTINBURNU', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Health Sciences in Biruni University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'UGUR CAVLAK, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biruni University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biruni University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CLINICAL PROFESSOR', 'investigatorFullName': 'Ugur Cavlak', 'investigatorAffiliation': 'Biruni University'}}}}