Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 1:44 PM
Study NCT ID:
NCT01360359
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-09', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trunk Neuromuscular Control', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Using surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.'}], 'secondaryOutcomes': [{'measure': 'Clinical Outcomes', 'timeFrame': 'Baseline, 8-weeks', 'description': 'Oswestry Disability Index- measure of self-perceived functional limitations NPRS- numeric pain index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['low back pain', 'core stabilization', 'trunk muscle exercises', 'physical therapy', 'RCT'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized clinical trial of low back pain exercise programs is to determine if trunk control can be changed by core stabilization exercises. The proposed mechanism of pain reduction and functional improvement of core stabilization exercises is that it enhances trunk movement and muscle control. This study will provide preliminary evidence of the link between patient outcomes and treatment mechanisms.\n\nThe investigators hypothesize that:\n\n* both treatment groups will demonstrate significant improvements in pain and function;\n* only subjects in the core stabilization group will demonstrate significant improvements in trunk movement and muscle control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. duration of the current episode less than 3 months,\n2. average pain intensity over past 2 weeks greater than 4 on an 11 point (0 = no pain, 10 = worst pain ever) verbal pain rating scale,\n3. self-report global function less than 80% (0-100 %, 100% = normal pain free function)\n4. Oswestry Index \\> 19%\n5. no physical therapy or chiropractic treatment for the current episode of low back pain.\n6. clinical diagnosis of poor trunk control/ clinical lumbar instability needs to be met based upon completion of specific physical therapy examination finding\n\nExclusion Criteria:\n\n1. permanent structural spinal deformity (e.g., scoliosis),\n2. spinal fracture or history of spinal fracture,\n3. osteoporosis,\n4. inflammatory joint disease,\n5. signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection),\n6. previous spinal surgery,\n7. frank neurological loss, i.e., weakness and sensory loss in a NR distribution,\n8. pain or paresthesia below the knee,\n9. leg length discrepancy of greater than 2.5 cm,\n10. history of neurologic disease that required hospitalization,\n11. active treatment of another medical illness that would preclude participation in any aspect of the study,\n12. pregnancy,\n13. vestibular dysfunction,\n14. extreme psychosocial involvement\n15. allergies to medical tape or adhesives\n16. Body mass index greater than 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT01360359', 'briefTitle': 'Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)', 'organization': {'class': 'OTHER', 'fullName': 'Drexel University'}, 'officialTitle': 'Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)', 'orgStudyIdInfo': {'id': 'K01HD053632', 'link': 'https://reporter.nih.gov/quickSearch/K01HD053632', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K01HD053632', 'link': 'https://reporter.nih.gov/quickSearch/K01HD053632', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Core Stabilization', 'description': '8-week core stabilization program in 3 stage that emphasizes use of specific local trunk stabilizing muscles to restore active control and stability to the trunk.\n\n8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions', 'interventionNames': ['Other: Core Stabilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trunk Motion and Fitness', 'description': '8-week exercise program in 3 stages emphasizing spine motion, general trunk flexibility and strengthening and cardiovascular fitness.\n\n8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions', 'interventionNames': ['Other: Trunk Motion and Fitness']}], 'interventions': [{'name': 'Core Stabilization', 'type': 'OTHER', 'description': '3 Stages: Stage 1: emphasis on neutral spine position, co-contraction of stabilizing muscles with performance feedback through observation and palpation for correct muscle activation; patient education\n\nStage 2: promotes maintenance of co-contraction while performing movements of the arms/legs and trunk progressing to preformance of these exercises on unstable surfaces; trunk muscle conditioning also emphasized; feedback gradually reduced.\n\nStage 3: emphasis on maintenance of co-contraction while performing functional activities; stable and unstable surfaces; use of perturbation and random practice to enhance motor learning.', 'armGroupLabels': ['Core Stabilization']}, {'name': 'Trunk Motion and Fitness', 'type': 'OTHER', 'description': '3 Stages: Stage 1: reducing pain and restoring spine motion and flexibility; patient education\n\nStage 2: trunk muscle conditioning exercises\n\nStage 3: trunk muscle conditioning and cardiovascular conditioning exercises', 'armGroupLabels': ['Trunk Motion and Fitness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University Physical Therapy', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19380', 'city': 'West Chester', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Optimum Physical Therapy Associates', 'geoPoint': {'lat': 39.96097, 'lon': -75.60804}}], 'overallOfficials': [{'name': 'Sheri P. Silfies, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drexel University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drexel University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sheri Silfies', 'investigatorAffiliation': 'Drexel University'}}}}