Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-31 @ 3:01 PM
Study NCT ID:
NCT05687695
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2022-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2023-01-07', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in trunk flexors, extensors and hip extensors, abductors muscles strength', 'timeFrame': 'measured twice before and after 6 weeks of intervention', 'description': 'concentric peak torque of trunk flexors and extensors and hip extensors and abductors'}, {'measure': 'Change in core muscles endurance', 'timeFrame': 'measured twice before and after 6 weeks of intervention', 'description': 'core muscles endurance assessed by McGill endurance tests'}], 'secondaryOutcomes': [{'measure': 'Change in pain severity assessed by visual analogue scale', 'timeFrame': 'measured twice before and after 6 weeks of intervention', 'description': 'The Visual Analogue Scale will be used for measuring the pain intensity. It consists of a line, 10 cm long, whose ends are labeled as; no pain and very extreme pain. The line is marked for each 1 cm without any label. Patients are simply asked to indicate which point along the line that best represents their pain intensity. The distance from the "no pain" end to the mark made by the patient will be measured as the patient pain intensity score. VAS is a valid and reliable tool for pain measurement'}, {'measure': 'Change in pain related disability and quality of life', 'timeFrame': 'measured twice before and after 6 weeks of intervention', 'description': 'The Oswestry Disability Index 10 criteria will be used to assess the degree of functional impairment includes pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and travelling. The ODI scores is expressed in percentages and ranges from 0 (minimum disability) to 100 % (maximum disability).\n\nFor each section the total possible score is 5: if the first statement is marked the section score= 0; if the last statement is marked, it= 5. For example, if all 10 sections are completed the score is calculated as follows: 16 (total scored) ÷ 50 (total possible score) x 100 = 32%. If one section is missed or not applicable the score is calculated as follows: 16 (total scored) ÷ 45 (total possible score) x 100 = 35.5%.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSLBP'], 'conditions': ['Non-specific Low Back Pain']}, 'descriptionModule': {'briefSummary': 'evaluation of core muscles endurance and strength following backward walking training programe', 'detailedDescription': "A randomized controlled trial will be conducted at the Isokinetic laboratory, Faculty of Physical Therapy, Cairo University, to investigate the effect of backward walking training on core muscles strength and endurance, pain severity, and disability level in subjects with NSLBP. Sixty females clinically diagnosed with nonspecific low back pain with age range from 18-45 years will participate in the study. They will be randomly assigned into 3 groups according to the received intervention; backward walking group (BWG), core stability group (CSG), and control group (CG). The isokinetic strength of trunk muscles, and hip extensors and abductors will be evaluated in a concentric mode of muscle contraction. McGill's core endurance tests will be used to examine participants' core endurance. The visual analog scale will be used for measuring the pain intensity. The oswestry disability index will be used to assess pain related disability and quality of life in subjects with LBP."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'there is gender related difference in the incidence of low back pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will be included if they have a history of LBP for more than 6 weeks before the study, or experienced at least 3 episodes of LBP each lasting more than one week, during the year before the study.\n\nExclusion Criteria:\n\n* Participants will be excluded if they have:\n\n 1. LBP as a result of a specific spinal condition (e.g. spondylolisthesis, or spinal stenosis).\n 2. Previous abdominal or spinal surgery.\n 3. Serious spinal conditions (e.g., vertebral fracture, tumor or infection).\n 4. Severe musculoskeletal deformity (scoliosis or kyphosis).\n 5. Inflammatory disorders (e.g. Rheumatoid arthritis).\n 6. Radicular symptoms consistent with a disc herniation, or cauda equina syndrome.\n 7. Pain and dysfunction in the upper and lower extremity that would interfere with testing.\n 8. Current pregnancy.\n 9. Marked leg length discrepancy greater than 2 cm.'}, 'identificationModule': {'nctId': 'NCT05687695', 'briefTitle': 'Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003264'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'backward walking training group', 'description': 'six weeks of backward walking training program 3 times per week', 'interventionNames': ['Other: backward walking program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'core training group', 'description': 'six weeks of core training 3 times per week', 'interventionNames': ['Other: core training']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'patients will not receive any intervention for six weeks'}], 'interventions': [{'name': 'backward walking program', 'type': 'OTHER', 'description': 'six weeks of backward walking program at self selected speed for 30 minutes 3 times per week', 'armGroupLabels': ['backward walking training group']}, {'name': 'core training', 'type': 'OTHER', 'description': 'six weeks of core training program including curl up, lateral plank on both sides, bird dog exercises done 3 times per week', 'armGroupLabels': ['core training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Giza', 'state': 'Dokki', 'country': 'Egypt', 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Salam M Elhafez, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of biomechanics', 'investigatorFullName': 'Alaa Amr Ahmed Mohammed', 'investigatorAffiliation': 'Cairo University'}}}}