Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-03-15 @ 12:01 PM
Study NCT ID:
NCT03660956
Status:
COMPLETED
Last Update Posted:
2021-08-11
First Post:
2018-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise and Back Counselling for Nurses
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'}]}, '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': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Quasi-Experimental design is used in this study. Participants are randomly assigned to exercise and back counselling group or back counselling only group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Pain on Visual Analogue Scale (VAS) at week 6, week 12, month 3, and month 6', 'timeFrame': 'Baseline, week 6, week 12, month 3, month 6.', 'description': 'Visual Analogue Scale (VAS) is used in this study to assess the intensity of low back pain with numeric rating scale 0-100 mm during the past month.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Musculoskeletal Symptoms in the Low Back Area at week 6, week 12, month 3 and month 6', 'timeFrame': 'Baseline, week 6, week 12, month 3, month 6.', 'description': 'Version of the low back questionnaire in Nordic Musculoskeletal Questionnaire (NMQ) is used in this study to assess the musculoskeletal symptoms in the low back area.'}, {'measure': 'Change from Baseline Functional Status at week 6, week 12, month 3 and month 6', 'timeFrame': 'Baseline, week 6, week 12, month 3, month 6', 'description': 'Chinese version of Oswestry Disability Index (ODI) is used in this study to assess the baseline functional status and its change over time for patients with back pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Low back pain (LBP) is most common occupational health problem among nurses. Therefore, how to prevent and reduce low back pain have been the important issue for nurses. A Quasi-Experimental design is used in this study to compare the effectiveness of 12-week exercise and counselling program to reduce low back pain in nursing personnel compared with counselling alone.', 'detailedDescription': 'A Quasi-Experimental design is used in this study. Purposive sampling is used to recruit participants from medical center in Central Taiwan. Participants will be randomly assigned to two groups: (1) exercise and back counselling, and (2) back counselling only. The results of this study will provide a guideline for nurses to prevent and to improve low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has worked at current job for at least 12 months;\n2. Intensity of low back pain on Visual Analogue Scale (scale 0-10) at least two during the past 3 months.\n\nExclusion Criteria:\n\n1. Serious former back injury (fracture, surgery, disc protrusion);\n2. Pregnant;\n3. Other serious disease or symptoms that limit participation exercise defined by a physician.'}, 'identificationModule': {'nctId': 'NCT03660956', 'briefTitle': 'Effects of Exercise and Back Counselling for Nurses', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Comparative Effects of Exercise and Back Counselling on Improving Low Back Pain for Nurses', 'orgStudyIdInfo': {'id': 'CMUH107-REC2-120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise and back counselling group', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Back counselling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Back counselling group', 'interventionNames': ['Behavioral: Back counselling']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Twelves-week exercise training sessions include a variety of strength, flexibility, and coordination exercises. Each exercise session lasts for one hour. Participants are expected to attend exercise session once a week and are encouraged to continue exercising at home.', 'armGroupLabels': ['Exercise and back counselling group']}, {'name': 'Back counselling', 'type': 'BEHAVIORAL', 'description': 'Procedure of back counselling includes one session back counselling, lasting one hour. The topics of back counselling session are as follows: (1) Anatomy of lumbar; (2) Factors causing low back pain; (3) Problems of physical inactivity for the lumbar; (4) Risk of poor postures for developing persistent/chronic low back pain; (5) Maintaining right posture of the lumbar; (6) Avoiding harmful loading of the back during work and leisure time.', 'armGroupLabels': ['Back counselling group', 'Exercise and back counselling group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '406040', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Hsin-Hsin Shih, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}