Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-03 @ 4:10 PM
Study NCT ID:
NCT02112760
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-10', 'studyFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2014-04-10', 'lastUpdatePostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increased change of sliding of transversus abdominis muscle and change of thickness on multifidus muscle in asymptomatic and low back pain group', 'timeFrame': 'pre treatment (0 week), post treatment(6 week)'}], 'secondaryOutcomes': [{'measure': 'Decrease cold sensation threshold on left back and hot sensation threshold on left leg in both group', 'timeFrame': 'pre treatment (0 week), post treatment(6 week)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['specific stabilization exercise', 'ultrasound', 'low back pain'], 'conditions': ['Recurrent Low Back Pain']}, 'descriptionModule': {'briefSummary': '1. Specific aim 1:Identify factors that influence muscle performance by use of ultrasound imaging.\n\n Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles.\n2. Specific aim 2. To compare the performance of trunk deep muscles (transversus abdominis and multifidus) and the sensation and pain thresholds of patients with recurrent low back pain with asymptomatic subjects.\n\n Hypothesis: patients with recurrent low back pain have:\n\n (A) less activation of the transversus abdominis and multifidus, (B) peripheral and central sensitization, with decreased sensation and pain thresholds in the lumbar and foot areas.\n3. Specific aim 3. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by use of ultrasound feedback training in asymptomatic adults, and to compare these results with the traditional training protocols for trunk stabilization.\n\n Hypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in asymptomatic adults.\n4. Specific aim 4. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by using the ultrasound feedback training in adults with low back pain, and to compare these results with the traditional training protocols for trunk stabilization.\n\nHypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in adults with low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recurrent low back pain for at least the past year\n* lumbar region discomfort more than one day in the past three months\n* recurrent discomfort more than one time in the past three months\n\nExclusion Criteria:\n\n* pregnancy\n* carcinoma\n* systematic disease (rheumatic arthritis, ankylosing spondylitis etc)\n* had surgery on lumbar region or lower extremities\n* neurological symptom on lower extremities(numbness, pain etc)\n* spondylolisthesis'}, 'identificationModule': {'nctId': 'NCT02112760', 'briefTitle': 'Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain', 'orgStudyIdInfo': {'id': '200903075R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient', 'description': 'To evaluate the effect of specific stabilization intervention in recurrent low back pain participants', 'interventionNames': ['Other: specific stabilization exercise']}], 'interventions': [{'name': 'specific stabilization exercise', 'type': 'OTHER', 'description': 'The specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback.', 'armGroupLabels': ['Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10060', 'city': 'Taipei', 'state': 'ZhongZeng District', 'country': 'Taiwan', 'facility': 'School of Physical Therapy, National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Shwu-Fen Wang, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'chool of Physical Therapy, National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}