Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT04960358
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2021-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surface Electromyography in Stratifying Chronic Low Back Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-11', 'releaseDate': '2021-12-29'}], 'estimatedResultsFirstSubmitDate': '2021-12-29'}}, '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': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2021-07-04', 'studyFirstSubmitQcDate': '2021-07-04', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Low Back Pain Disability Questionnaire', 'timeFrame': '1 YEAR', 'description': 'Questionnaire of the functional assessment for the low back pain patient'}, {'measure': 'Flexion Relaxation Response (FRR) ratio', 'timeFrame': '1 YEAR', 'description': 'The FRR ratio was calculated from the best SEMG values obtained during Forward Lumbar Flexion \\& Extension'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '1 YEAR', 'description': 'Representing range of pain intensity from no pain on the far left to most intense pain on the far right.'}, {'measure': 'Gross Range of Motion', 'timeFrame': '1 YEAR', 'description': 'Degree of trunk motion at maximum voluntary flexion, measured by inclinometer at the level of T12'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Surface Electromyography can be utilised to detect normal muscle electrical activity during maximum forward flexion termed Flexion Relaxation Response (FRR)', 'detailedDescription': 'In this study, our primary objective is to assess FRR and disability (ODI) correlation protocol as an objective tool in stratifying Chronic LBP. We also would like to evaluate the relationship between FRR with pain intensity and lumbar range of motion as our secondary objective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with low back pain who were being referred to the rehabilitation outpatient in University Malaya Medical Centre between November 2019 until July 2020.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged between 20 - 70 years old\n* Mechanical LBP \\> 6 weeks (not acute LBP)\n* Not received any specific exercise spinal manipulation or surgery to improve LBP within the last 3 months.\n\nExclusion Criteria:\n\n* Pregnancy\n* Radicular LBP patients or specific-spinal pathology / "red-flags".\n* Surgical intervention for the current LBP complaint (includes traumatic causes of LBP with surgical intervention)\n* Cognitive or communication difficulty preventing active participation in exercises or communicating pain scores'}, 'identificationModule': {'nctId': 'NCT04960358', 'briefTitle': 'Surface Electromyography in Stratifying Chronic Low Back Pain.', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'The Application Of Surface Electromyography (SEMG) In Stratifying Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '201948-7312'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic LBP', 'description': 'Will be applied Surface Electromyography', 'interventionNames': ['Procedure: Surface Electromyography']}], 'interventions': [{'name': 'Surface Electromyography', 'type': 'PROCEDURE', 'description': 'will be applied Surface Electromyography to assess Flexion Relaxation Response', 'armGroupLabels': ['Chronic LBP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'ANWAR SUHAIMI, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr Anwar Suhaimi', 'investigatorAffiliation': 'University of Malaya'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-12-29', 'type': 'RELEASE'}, {'date': '2022-03-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr Anwar Suhaimi, Clinical Professor, University of Malaya'}}}}