Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-02-20 @ 6:04 PM
Study NCT ID:
NCT06330792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Physiotherapists will be randomly subdivided into two equal groups in number. Group (A) (Experimental Group): This group will receive biomechanical awareness advices while working and core stability exercises.\n\nGroup (B) (Control Group): This group will receive core stability exercises only.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intensity of low back pain', 'timeFrame': '1 month', 'description': 'we will assess intensity of low back pain by using visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'back muscle endurance', 'timeFrame': '1 month', 'description': 'assess back muscle endurance by using Sorensen test'}, {'measure': 'level of function (disability) associated with mechanical Low Back Pain', 'timeFrame': '1 month', 'description': 'the Arabic version of Oswestry Disability Index will be used to determine the level of function associated with mechanical Low Back Pain'}, {'measure': 'Fatigue Severity', 'timeFrame': '1 month', 'description': 'The Arabic version of The Fatigue Severity Scale will be used to measure fatigue in people with mechanical Low Back Pain'}, {'measure': 'psycho-social factors at work', 'timeFrame': '1 month', 'description': 'The English version of The Brief Job Stress Questionnaire which is valid in the measurement of psycho-social factors at work and this Questionnaire can be one of the methodological tools to explore the mechanisms between job stress and several work-related disorders and can provide hints of intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical awareness', 'core stability exercises'], 'conditions': ['Mechanical Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '29573870', 'type': 'BACKGROUND', 'citation': 'Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.'}, {'pmid': '26007284', 'type': 'BACKGROUND', 'citation': 'Vieira ER, Svoboda S, Belniak A, Brunt D, Rose-St Prix C, Roberts L, da Costa BR. Work-related musculoskeletal disorders among physical therapists: an online survey. Disabil Rehabil. 2016;38(6):552-7. doi: 10.3109/09638288.2015.1049375. Epub 2015 May 26.'}, {'pmid': '31908589', 'type': 'BACKGROUND', 'citation': 'Areeudomwong P, Buttagat V. Comparison of Core Stabilisation Exercise and Proprioceptive Neuromuscular Facilitation Training on Pain-related and Neuromuscular Response Outcomes for Chronic Low Back Pain: A Randomised Controlled Trial. Malays J Med Sci. 2019 Nov;26(6):77-89. doi: 10.21315/mjms2019.26.6.8. Epub 2019 Dec 30.'}]}, 'descriptionModule': {'briefSummary': 'investigate the effect of bio-mechanical awareness and core stability exercises on mechanical low back pain among Egyptian Physiotherapists', 'detailedDescription': 'The aims of this study are:\n\n1. to investigate the effect of bio-mechanical awareness and core stability exercises on the intensity of low back pain among Egyptian Physiotherapists.\n2. to investigate the effect of bio-mechanical awareness and core stability exercises on and back muscle endurance among Egyptian Physiotherapists.\n3. to investigate the effect of bio-mechanical awareness and core stability exercises on level of function (disability) associated with low back pain among Egyptian Physiotherapists.\n4. to investigate the effect of bio-mechanical awareness and core stability exercises on fatigue among Egyptian Physiotherapists.\n5. to investigate the effect of bio-mechanical awareness and core stability exercises on psycho-social factors at work among Egyptian Physiotherapists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'inclusion criteria:\n\n* Egyptian Physiotherapists with non-specific low back pain.\n* Physiotherapy graduate who worked for at least two years (Khairy et al.,2019).\n* Age range from 25 to 40 years old (Pellissier et al., 2023).\n* Male and female.\n* Normal BMI ranges between 18.5:24.9 kg/m2.\n\nexclusion criteria:\n\n* Physiotherapists outside the target range age an BMI.\n* Students of physical therapy or Physiotherapists who worked for less than two years.\n* Physiotherapists who had lumbar spine surgery.\n* Physiotherapists who had history sever lumbar problem spondylolisthesis, tumor, fracture.\n* Physiotherapists who suffers from vertigo.'}, 'identificationModule': {'nctId': 'NCT06330792', 'briefTitle': 'Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain Among Egyptian Physiotherapists', 'orgStudyIdInfo': {'id': 'mechanical low back pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'effect of biomechanical awareness and core stability exercises on mechanical low back pain', 'interventionNames': ['Other: bio-mechanical awareness', 'Other: core stability exercises']}, {'type': 'OTHER', 'label': 'effect core stability exercises on mechanical low back pain', 'interventionNames': ['Other: core stability exercises']}], 'interventions': [{'name': 'bio-mechanical awareness', 'type': 'OTHER', 'description': 'Biomechanical awareness advices for physiotherapists during session: consist of group of awareness advices and McKenzie extension part method exercises to help physiotherapist working in correct position and consume his energy.', 'armGroupLabels': ['effect of biomechanical awareness and core stability exercises on mechanical low back pain']}, {'name': 'core stability exercises', 'type': 'OTHER', 'description': 'Core stabilization exercise Program: The procedure for core stabilization exercises to improve core muscles in lumbar area', 'armGroupLabels': ['effect core stability exercises on mechanical low back pain', 'effect of biomechanical awareness and core stability exercises on mechanical low back pain']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Baza, B.Sc', 'role': 'CONTACT', 'email': 'mohamedbaza588@gmail.com', 'phone': '+2001017931442'}, {'name': 'Doaa Elimy, lecturer', 'role': 'CONTACT', 'email': 'do3aayoub25@gmail.com', 'phone': '+2001066474654'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Ibrahim Ahmed Baza', 'investigatorAffiliation': 'Cairo University'}}}}