Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT06864650
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-03-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Ergonomic Training and Exercise in Automotive Factory Workers With Nonspecific Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006804', 'term': 'Ergonomics'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D004738', 'term': 'Engineering'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Low Back Pain Disability Questionnaire', 'timeFrame': '14 weeks', 'description': 'It was developed to measure the functionality of individuals. The scale determines functional disability for activities such as sitting, walking, personal care, lifting, social life, travel, and sleep. There are 10 questions in this scale. Each question has 6 options. Participants are asked to choose the definition that best describes their situation from these options. A score of 0-5 is assigned for each of the sentences, and the highest possible score is 50 points. It is evaluated as mild between 1 and 10 points, moderate between 11 and 30 points, and severe between 31 and 50 points.'}, {'measure': 'The Pittsburgh Sleep Quality Index', 'timeFrame': '14 weeks', 'description': 'Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality'}, {'measure': 'Short form of the International Physical Activity Questionnaire', 'timeFrame': '14 weeks', 'description': "It consists of 8 questions with a recall period defined as 'last week'. The questions of the scale ask whether the participant walks for at least 10 minutes on any given day or does moderate or vigorous activities, and how much time/day the individual spends on each of these activities."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Work-related Illness']}, 'referencesModule': {'references': [{'pmid': '26891640', 'type': 'BACKGROUND', 'citation': 'Stieglitz DD, Vinson DR, Hampton MC. Equipment-based Pilates reduces work-related chronic low back pain and disability: A pilot study. J Bodyw Mov Ther. 2016 Jan;20(1):74-82. doi: 10.1016/j.jbmt.2015.06.006. Epub 2015 Jun 15.'}, {'pmid': '29321099', 'type': 'BACKGROUND', 'citation': 'Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.'}, {'pmid': '38701125', 'type': 'BACKGROUND', 'citation': 'Pehlevan E, Sevgin O. Effect of exercise given to factory workers with ergonomics training on pain and functionality: A randomized controlled trial. Work. 2024;78(1):195-205. doi: 10.3233/WOR-230663.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the effectiveness of ergonomic training and exercise in automotive factory workers with chronic low back pain of unknown cause.', 'detailedDescription': 'The study was planned as a randomized controlled study. Workers between the ages of 18-60 who have back pain and work in an automotive factory in Galway, Ireland will be included in the study. Participants will be divided into two groups. The factory workers included in the study will be divided into a study group and a control group using a simple random method. Randomization will be done using the sealed envelope method. The study group will be given stretching and strengthening exercises along with ergonomics training. The control group will be given only ergonomics training. The exercises they will do and the ergonomics training will be explained to the participants individually and supported with a brochure. The participants will be asked to do the given exercises 3 days a week and continue for 12 weeks. The given exercises will be followed up with an exercise follow-up chart. In order to collect data on the sociodemographic characteristics of the participants, a personal information form will be prepared by the researcher and the participants will be asked to fill it out. In order to collect data from the participants; Visual Analog Scale will be used to collect information about pain, International Physical Activity Questionnaire to collect information about physical activity levels, Pittsburgh Sleep Quality Questionnaire to determine sleep quality, Oswestry Low Back Pain Scale for functionality assessment, Manual Muscle Testing to determine muscle strength. These questionnaires will be repeated before starting the study and at the end of the study. The data to be obtained will be evaluated using SPSS 24 package program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18-60 years old\n* Having worked in the same factory for at least 2 years\n* Working full time\n* Having complained of back pain for at least 3 months\n* visual analog scale\\>4, pain 4 and above on visual analog scale\n\nExclusion Criteria\n\n* Being under 18 years old or over 60 years old\n* Having worked for less than 2 years\n* Working part time\n* Having complained of back pain for less than 3 months\n* visual analog scale Presence of psychological problems\n* Using sleeping pills\n* Having undergone surgical intervention in the last 6 months'}, 'identificationModule': {'nctId': 'NCT06864650', 'briefTitle': 'Effectiveness of Ergonomic Training and Exercise in Automotive Factory Workers With Nonspecific Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'Effectiveness of Ergonomic Training and Exercise in Automotive Factory Workers With Nonspecific Chronic Low Back Pain: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Uskudar25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ergonomics training', 'description': 'group without any intervention', 'interventionNames': ['Other: Ergonomics training']}, {'type': 'EXPERIMENTAL', 'label': 'Ergonomics training +exercise program', 'description': 'The group that followed the 12-week exercise program', 'interventionNames': ['Other: Ergonomics training', 'Other: exercise program']}], 'interventions': [{'name': 'Ergonomics training', 'type': 'OTHER', 'description': 'Each of the control group participants will receive separate ergonomics training. The content of this training will include the topics of "what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk factors."', 'armGroupLabels': ['Ergonomics training', 'Ergonomics training +exercise program']}, {'name': 'exercise program', 'type': 'OTHER', 'description': 'stretching exercises strengthening exercises waist exercises core exercises relaxation exercises', 'armGroupLabels': ['Ergonomics training +exercise program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Galway', 'country': 'Ireland', 'facility': 'Valeo Vision System', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}], 'overallOfficials': [{'name': 'Kübra TOSYALI', 'role': 'STUDY_CHAIR', 'affiliation': 'Uskudar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof. Dr.', 'investigatorFullName': 'Dr. Öğr. Üyesi Ömer Şevgin', 'investigatorAffiliation': 'Uskudar University'}}}}