Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT02901327
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2016-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-19', 'studyFirstSubmitDate': '2016-06-09', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of Multifidus Muscle Activation', 'timeFrame': '8 weeks of intervention', 'description': 'using the surface electromyography'}], 'secondaryOutcomes': [{'measure': 'Functional Disability status', 'timeFrame': 'Baseline', 'description': 'using the modified Oswestry disability index questionnaire'}, {'measure': 'Functional Disability status', 'timeFrame': '8 weeks', 'description': 'using the modified Oswestry disability index questionnaire'}, {'measure': 'Pain Intensity', 'timeFrame': 'Baseline', 'description': 'using the VAS'}, {'measure': 'Pain Intensity', 'timeFrame': '8 weeks', 'description': 'using the VAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lumbar Stabilisation Exercise', 'Treadmill Walk', 'Multifidus Muscle Activation', 'Pain Intensity', 'Functional Disability'], 'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Chronic Mechanical Low Back Pain (CMLBP) is a common disabling health problem among the general population. Multifidus muscle inhibition accompanying CMLBP plays a major role in perpetuating the pain and functional disability. Lumbar stabilisation and treadmill exercises are established treatments for CMLBP. However, it is not known which of the two techniques is more effective. This study was conducted to compare the effects of lumbar stabilisation and treadmill walk on multifidus activation, pain and functional disability in individuals with CMLBP.', 'detailedDescription': 'Fifty-three individuals (23 females and 30 males) with CMLBP participated in this single blind randomised clinical trial. Consecutive participants were recruited from the outpatient Physiotherapy clinic of the Aminu Kano Teaching Hospital, Kano, Nigeria and were randomly assigned to one of two exercise groups: Lumbar Stabilisation Group (LSG; n = 27) or Treadmill Walk Group (TWG; n = 26). However, 50 participants, (LSG: n = 25; and TWG: n = 25) completed the eight week study. Participants in the LSG had lumbar stabilisation exercises using McGill protocol while those in the TWG had walking exercise on a treadmill using the Bruce protocol. Treatment was applied three times weekly for eight weeks. Outcomes assessed at baseline and end of eighth week of study were: Pain Intensity (PI) using Visual Analogue scale, Functional Disability (FD) using Oswestry Disability Index Questionnaire; and Multifidus Muscle Activation (MMA) level using a surface electromyography machine. Data were analysed using descriptive statistics, paired and independent t-tests at α0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants diagnosed with LBP of mechanical origin and have been present for 3 months or more.\n2. Participants who have a score of at least 20% on Modified Oswestry Dis¬ability Index (ODI).\n3. Participants who gave consent to participate in the study.\n4. Participants who can comprehend instructions in English or Hausa\n5. Participants who are not involved in any other form of exercise training during the course of the study.\n\nExclusion Criteria:\n\n1. Patients with history of a prior surgery to the lumbosacral spine.\n2. Patients with any neurological findings indicating radiculopathy.\n3. Patients with very acute symptoms of LBP.\n4. Patients with evidence of systemic disease, carcinoma or organ diseases.\n5. Patients with obesity which due to reduce fatty infiltration that might affect electrical conductivity in the multifidus muscle.\n6. Patients below 18 years of age.'}, 'identificationModule': {'nctId': 'NCT02901327', 'acronym': 'CMLBP', 'briefTitle': 'Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Bayero University Kano, Nigeria'}, 'officialTitle': 'Effects of Lumbar Stabilisation Exercise and Treadmill Walk on Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'BayeroUK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumbar Stabilisation Exercise', 'description': '30 minute lumbar stabilization exercise, 3 times per week for 8 weeks.', 'interventionNames': ['Procedure: Lumbar Stabilisation Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treadmill walk exercise', 'description': 'Walking exercise on a treadmill for a maximum of 30 minutes with increasing speed and inclination. 3 times/week for 8 weeks.', 'interventionNames': ['Procedure: treadmill walk exercise']}], 'interventions': [{'name': 'Lumbar Stabilisation Exercise', 'type': 'PROCEDURE', 'otherNames': ['Core Exercise'], 'description': "McGill protocol starting with:\n\n1. 'cat-camel' exercise exercise 10 repetitions with 7 seconds hold each\n2. 'curl-up' exercise 10 repetitions with 7 seconds hold each\n3. 'side-bridge' exercise 10 repetitions with 7 seconds hold each\n4. 'cat-camel' exercise 10 repetitions with 7 seconds hold each progression was based on subjects' tolerance and endurance.", 'armGroupLabels': ['Lumbar Stabilisation Exercise']}, {'name': 'treadmill walk exercise', 'type': 'PROCEDURE', 'otherNames': ['Aerobic Exercise'], 'description': "Bruce protocol\n\nThis include:\n\n1. '5 minutes warm up' at zero degree inclination.\n2. '20 minutes active exercise with increasing speed and inclination'\n3. '5 minutes cool down'", 'armGroupLabels': ['Treadmill walk exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '234777', 'city': 'Kano', 'state': 'Kano State', 'country': 'Nigeria', 'facility': 'Aminu Kano Teaching Hospital', 'geoPoint': {'lat': 12.00012, 'lon': 8.51672}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayero University Kano, Nigeria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'BASHIR BELLO', 'investigatorAffiliation': 'Bayero University Kano, Nigeria'}}}}