Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-04 @ 9:34 AM
Study NCT ID:
NCT05921032
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2023-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Biomechanics, Function and Pain and Effects of Exercise Intervention Among Nurses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2023-06-24', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lumbar angle from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load'}, {'measure': 'Change in pelvic tilt angle from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load'}, {'measure': 'Change in hip angle from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load'}, {'measure': 'Change in knee angle from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load'}, {'measure': 'Change in ankle angle from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load'}, {'measure': 'Change in back extensor muscle power from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Grading of muscle strength (Oxford Scale) will be used to assess back extensor muscle power. 0/5 = no muscle movement, 1/5 = muscle movement without joint motion, 2/5 = movement with gravity eliminated, 3/5 = movement against gravity but not against resistance, 4/5 = movement against gravity and light resistance and 5/5 represents normal strength'}, {'measure': 'Change in functional disability from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': "Functional disability will be assessed by using the Roland-Morris Low Back Pain and Disability Questionnaire. Greater levels of disability are reflected by higher numbers of 24-point scale which represented 24 questions. Through analysis of serial questionnaire scores, a clinical improvement over time can be graded. For example, at the beginning of test, a participant's score was 10, and after test, her score was 2 (8 points of improvement). Therefore, the improvement percentage was 80% (8/10 x 100)."}, {'measure': 'Change in pain intensity from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Visual analogue scale (VAS) will be used to assess the pain intensity. The minimum values "0" referring to no pain and maximum values "10" referring to worst imaginable pain.'}, {'measure': 'Change in endurance of trunk muscles from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Trunk flexor muscle and extensor muscle will be tested according to the duration of the muscles contraction. Long time duration (more than 4 minutes) means the participant has no back pain.'}, {'measure': 'Change in hamstrings flexibility from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Flexibility of the lower back and hamstrings will be assessed by using sit and reach test. The scale will be referring to The American College of Sports Medicine (ACSM) which range from excellent to poor (in cm) according to their age.'}, {'measure': 'Change in full body gravitational reaction force from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load'}, {'measure': 'Change in full body moment from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load'}, {'measure': 'Change in full body center of pressure from baseline to post-intervention', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kinematics', 'Kinetics', 'Human health', 'Spine'], 'conditions': ['Nurses']}, 'referencesModule': {'references': [{'pmid': '23525973', 'type': 'BACKGROUND', 'citation': 'Moon HJ, Choi KH, Kim DH, Kim HJ, Cho YK, Lee KH, Kim JH, Choi YJ. Effect of lumbar stabilization and dynamic lumbar strengthening exercises in patients with chronic low back pain. Ann Rehabil Med. 2013 Feb;37(1):110-7. doi: 10.5535/arm.2013.37.1.110. Epub 2013 Feb 28.'}, {'pmid': '31923778', 'type': 'BACKGROUND', 'citation': 'Sipaviciene S, Kliziene I. Effect of different exercise programs on non-specific chronic low back pain and disability in people who perform sedentary work. Clin Biomech (Bristol). 2020 Mar;73:17-27. doi: 10.1016/j.clinbiomech.2019.12.028. Epub 2020 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the effects of exercise interventions (lumbar stabilisation exercise (LSE) versus lumbar muscles strengthening exercises (LMSE)) on full body mechanics, functional disability outcomes and pain score among female nurses with chronic non-specific low back pain (CNLBP). The main questions are:\n\n* What are the differences in full body mechanics, functional disability outcomes and pain score among female nurses with CNLBP?\n* How exercise intervention affects full body mechanics, functional disability outcomes and pain score among female nurses with CNLBP?\n\nParticipants will be divided into three groups (lumbar stabilisation exercise (LSE), lumbar muscles strengthening exercises (LMSE) and control group). Exercise intervention group will be asked to perform 8 weeks of exercise intervention with :\n\n* 3D kinematics and trunk spinal loads test\n* Trunk muscle power (extensor) test\n* Sit-and-reach test\n* Functional disability (Roland-Morris Low Back Pain and Disability Questionnaire, RMQ)\n* Pain intensity (Visual analogue scale, VAS)\n* Endurance of trunk muscle test\n\nMeanwhile control group will be given a diary to record their daily activities which consist of their 24 hours diet recall for 8 weeks and involvement of any physical activity throughout the 8 weeks.\n\nResearchers will compare between two exercise groups to see if there is any differences in full body mechanics, functional disability outcomes and pain score across different among female nurses with CNLBP.', 'detailedDescription': "* All participants are female nurses with age range between 20 - 55 years old from Hospital USM and have chronic LBP persisting for longer than three months.\n* Randomisation of participants' selection will be conducted using computer. The allocation numbers will be generated by the computer via excel formulas to get evenly distributed names into three groups.\n* The sample size is calculated using GPower software (v.3.1.9.7, Universität Düsseldorf, German) of Repeated Measure ANOVA with p value set at 0.05 and effect size is 0.75. Based on effect size, it showed that 15 participants per group are sufficient to yield 0.8 power of the study with four times of assessments (i.e., pre-intervention assessment, mid- intervention assessment, post- intervention assessment, and 1 month after intervention). By inclusion of 20% drop out rate a total of 54 participants were recruited with 18 participants per group (n=18).\n* Participants need to attend at least 75% of the training session and their data will not be evaluated if they do not meet this minimum adherence level.\n* All statistical analyses will be performed using Statistical Package for Social Science (SPSS) version 26.0 (IBM Inc., Armonk, New York, United States). The level of significance was set at p\\<0.05.All data will be tested for normal distribution via the Shapiro Wilk test. Repeated Measure ANOVA will be conducted to compare the lower extremity and trunk kinematics, endurance of trunk flexor and extensor muscles, functional disability, pain intensity values and anthropometric data across two groups at pre, middle, post and one month follow up after exercises intervention.\n* All 3D kinematics and trunk spinal loads test, trunk muscle power (extensor) test, sit-and-reach test, functional disability (Roland-Morris Low Back Pain and Disability Questionnaire, RMQ), pain intensity (Visual analogue scale, VAS) and endurance of trunk muscle test will be assessed during pre assessment, middle assessment (during fourth week of exercise intervention), post assessment and after one month follow up assessment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female nurses from Hospital USM\n* Had chronic non specific LBP persisting for longer than three months.\n* Treated as outpatients of HUSM\n\nExclusion Criteria:\n\n* history of cerebrovascular disease\n* chronic diseases that cause long-term immobilisation\n* history of previous spine surgery\n* diagnosed with spinal cord disease\n* history of rheumatic disease\n* diagnosed with cancer\n* history of neurological deficits\n* history of infectious and systemic disease\n* history of radicular pain due to nerve root involvement\n* history of structural lesion such as spondylosis\n* spondylolisthesis\n* scoliosis\n* kyphosis\n* vertebral bone fracture'}, 'identificationModule': {'nctId': 'NCT05921032', 'briefTitle': 'Comparison of Biomechanics, Function and Pain and Effects of Exercise Intervention Among Nurses', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Low Back Pain Among Nurses: Comparison of Biomechanics, Function and Pain Across Subtypes and Effects of Exercise Intervention.', 'orgStudyIdInfo': {'id': 'USM/JEPeM/19100637'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lumbar stabilisation exercise (LSE)', 'description': 'Lumbar stabilisation exercise (LSE) group will perform eight weeks exercise intervention for two sessions in a week. Each session took about 45 minutes to complete. The total exercise sessions were 16 sessions. LSE group will be focused on strengthening the deep trunk stabilising muscles (i.e., transverse abdominal, internal oblique and lumbar multifidus) and control pelvis muscles.', 'interventionNames': ['Other: Exercise intervention']}, {'type': 'OTHER', 'label': 'Lumbar muscle strengthening exercise (LMSE)', 'description': 'Lumbar muscle strengthening exercise (LMSE) group will perform eight weeks exercise intervention for two sessions in a week. Each session took about 45 minutes to complete. The total exercise sessions were 16 sessions. LMSE group aims to strengthen the trunk flexor and extensor muscles.', 'interventionNames': ['Other: Exercise intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will be given a diary to record their daily activities which consist of their 24 hours diet recall for 8 weeks and involvement of any physical activity throughout the 8 weeks. This diary will be collected during follow up (1 month after post-intervention). Upon completion of the trial, participants in the control group will receive either LSE or LMSE or combination of both exercises depending on their preference.'}], 'interventions': [{'name': 'Exercise intervention', 'type': 'OTHER', 'description': '8 weeks of exercise with two session in a week', 'armGroupLabels': ['Lumbar muscle strengthening exercise (LMSE)', 'Lumbar stabilisation exercise (LSE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16150', 'city': 'Kubang Kerian', 'state': 'Kelantan', 'country': 'Malaysia', 'facility': 'Universiti Sains Malaysia Kampus Kesihatan', 'geoPoint': {'lat': 6.09123, 'lon': 102.27938}}], 'overallOfficials': [{'name': 'Shazlin Shaharudin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Sains Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Iinvestigator', 'investigatorFullName': 'Shazlin Shaharudin', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}