Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-03-13 @ 1:50 AM
Study NCT ID:
NCT02895828
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2014-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Core Stabilization and Strengthening Exercise on Quality of Life in Clinical Lumbar Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2014-11-24', 'studyFirstSubmitQcDate': '2016-09-06', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of 2-exercise on quality of life', 'timeFrame': 'Change from baseline at 10-week after training session, and follow up session', 'description': 'health-related quality of life was measured by using SF-36 questionnaire'}], 'secondaryOutcomes': [{'measure': 'Effect of 2-exercise on physical disability', 'timeFrame': 'Change from baseline at 10-week after training session, and follow up session', 'description': 'Physical disability was measured by using Oswestry disability index'}, {'measure': 'Effect of 2-exercise on trunk muscle activity', 'timeFrame': 'Change from baseline at 10-week after training session, and follow up session', 'description': 'Trunk muscle activity was measured by using surface EMG'}, {'measure': 'Effect of 2-exercise on lumbar segmental motion', 'timeFrame': 'Change from baseline at 10-week after training session, and follow up session', 'description': 'Lumbar segmental motion was measured by using radiography'}, {'measure': 'Effect of 2-exercise on pain intensity', 'timeFrame': 'Change from baseline at 10-week after training session, and follow up session', 'description': 'Pain intensity was measured by using numeric rating scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '24399870', 'type': 'BACKGROUND', 'citation': 'Puntumetakul R, Areeudomwong P, Emasithi A, Yamauchi J. Effect of 10-week core stabilization exercise training and detraining on pain-related outcomes in patients with clinical lumbar instability. Patient Prefer Adherence. 2013 Nov 19;7:1189-99. doi: 10.2147/PPA.S50436. eCollection 2013.'}, {'pmid': '22935853', 'type': 'BACKGROUND', 'citation': 'Javadian Y, Behtash H, Akbari M, Taghipour-Darzi M, Zekavat H. The effects of stabilizing exercises on pain and disability of patients with lumbar segmental instability. J Back Musculoskelet Rehabil. 2012;25(3):149-55. doi: 10.3233/BMR-2012-0321.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the effects of 2 exercise programs including core stabilization exercise and general trunk strengthening exercise programs on trunk muscle activity, physical dysfunction, quality of life and lumbar motion in low back pain patient with clinical lumbar instability.', 'detailedDescription': 'Clinical lumbar instability is the one of causes of chronic low back pain, that affects to pain intensity and quality of life. For clinical studies using core stabilization exercise (CSE) as treatment have revealed conflicting findings on pain, functional disability and muscle responses in chronic low back pain. The CSE promotes local muscle system that to provide lumbar stability. However, the stability of spine related to global muscle system, that using in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic low back pain due to clinical lumbar instability\n\nExclusion Criteria:\n\n* Specific low back pain\n* Cuada equine syndrome\n* Neurological deficit'}, 'identificationModule': {'nctId': 'NCT02895828', 'briefTitle': 'Effects of Core Stabilization and Strengthening Exercise on Quality of Life in Clinical Lumbar Instability', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Clinical Practice Guideline With Core Stabilization and Strengthening Exercise Programs for Low Back Pain With Clinical Lumbar Instability', 'orgStudyIdInfo': {'id': 'HE562257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Core Stabilization Exercise (CSE)', 'description': 'The participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks', 'interventionNames': ['Other: Core Stabilization Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'General Strengthening Exercise (GSE)', 'description': 'The participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks.', 'interventionNames': ['Other: General Strengthening Exercise']}], 'interventions': [{'name': 'Core Stabilization Exercise', 'type': 'OTHER', 'description': 'the participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks', 'armGroupLabels': ['Core Stabilization Exercise (CSE)']}, {'name': 'General Strengthening Exercise', 'type': 'OTHER', 'description': 'the participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks', 'armGroupLabels': ['General Strengthening Exercise (GSE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40000', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Research Center in Back, Neck, Other Joint Pain and Human Performance', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Wantanee Yodchaisarn, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Khon Kaen University, Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Wantanee Yodchaisarn', 'investigatorAffiliation': 'Khon Kaen University'}}}}