Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-04-11 @ 6:09 PM
Study NCT ID:
NCT04772950
Status:
UNKNOWN
Last Update Posted:
2021-05-25
First Post:
2021-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Deep and Superficial Multifidus and the Activation Pattern During Dynamic Task Correlating With Trunk Stability Ability and Functional Performance in Different Ages Asymptomatic and Unspecific Low Back Pain Adult
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of superficial multifidus', 'timeFrame': '10 minutes', 'description': 'change of superficial multifidus during contraction by using ultrasound image'}, {'measure': 'Change of deep multifidus', 'timeFrame': '10 minutes', 'description': 'change of deep multifidus during contraction by using ultrasound image'}, {'measure': 'Disability index', 'timeFrame': '5 minutes', 'description': 'use Oswestry Disability Index'}, {'measure': 'Timed up and go test', 'timeFrame': '3 minutes', 'description': 'Examiner will record the seconds the subjects spend in the test including standing up, walking, turn around and sit down.'}, {'measure': 'Sit to stand test', 'timeFrame': '3 minutes', 'description': 'Subjects will repeat 5 times sit to stand and the seconds subjects spend will be recorded.'}, {'measure': 'Countermovement jump test', 'timeFrame': '3 minutes', 'description': 'The subjects start from an upright standing position, makes a preliminary downward movement by flexing at the knees and hips, then immediately extends the knees and hips again to jump vertically up off the ground. The distance which the subjects jump for will be recorded.'}, {'measure': 'Sahrmann five-level core stability test', 'timeFrame': '5 minutes', 'description': 'Examiner will use stabilizer pressure biofeedback unit to detect whether there is lumbar motion during different levels of lower extremities movement.'}, {'measure': 'Rotatory stability test', 'timeFrame': '3 minutes', 'description': 'Rotatory stability test is one of the test from functional movement screen. Subjects will start in quadruped position and move the extremities to maintain the spine in neutral position.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The first propose of the study is to understand the contraction of deep and superficial multifidus in patients with non-specific low back pain and the elderly. The second purpose of the study is to understand the relationship between the multifidus and the functional performance in patients with non-specific low back pain and the elderly. The hypothesis is that the patients with non-specific low back pain and the elderly have less ability to contract the deep multifidus then asymptomatic adults and younger adults. Besides, the multifidus is correlated to the functional performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with non-specific low back pain', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20-90\n* have lumbar region discomfort in the past three months, and the discomfort is more than one day\n* have diagnosis of non-specific low back pain\n\nExclusion Criteria:\n\n* have received surgery of lumbar or lower extremities\n* neurological symptom (eg. numbness of lower extremities)\n* have no ability to stand and walking independently\n* cancer\n* systemic disease (eg. ankylosing spondylitis, rheumatoid arthritis, Systemic lupus erythematosus)\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04772950', 'briefTitle': 'Measuring Deep and Superficial Multifidus and the Activation Pattern During Dynamic Task Correlating With Trunk Stability Ability and Functional Performance in Different Ages Asymptomatic and Unspecific Low Back Pain Adult', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Measuring Deep and Superficial Multifidus and the Activation Pattern During Dynamic Task Correlating With Trunk Stability Ability and Functional Performance in Different Ages Asymptomatic and Unspecific Low Back Pain Adult', 'orgStudyIdInfo': {'id': '202012034RINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy adults'}, {'label': 'Patients with non-specific low back pain'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shing-Tian Chiang', 'role': 'CONTACT', 'email': 'tian090808@gmail.com', 'phone': '0975314583'}], 'facility': 'Shing-Tian, Chiang', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Shing-Tian Chiang', 'role': 'CONTACT', 'email': 'tian090808@gmail.com', 'phone': '097531458'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}