Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-05 @ 6:02 PM
Study NCT ID:
NCT02047669
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2014-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086342', 'term': 'Models, Biopsychosocial'}], 'ancestors': [{'id': 'D008962', 'term': 'Models, Theoretical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2014-01-26', 'studyFirstSubmitQcDate': '2014-01-26', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'WAI', 'timeFrame': 'change from baseline to week 10', 'description': 'Work ability index questionnaire'}, {'measure': 'Fear Avoidance', 'timeFrame': 'change from baseline to week 10', 'description': "Fear avoidance is evaluated by the Fear Avoidance Beliefs questionnaire (FABQ) by Waddell et al. at baseline and follow-up. Briefly, the FABQ is a two-part questionnaire. The first part consists of five questions/statements about pain and physical activity and the second part consists of 11 questions/statements about how work affects the participants' perception of pain. Each question is scored from 0-5 ranging from completely disagree (0) to completely agree (5)."}, {'measure': 'Muscle function', 'timeFrame': 'change from baseline to week 10', 'description': 'Muscle strength, function and tenderness of the shoulder, arm, wrist/hand is assessed by maximal isometric voluntary contractions in a custom-built dynamometer (Bofors Elektronik, Karlskoga, Sweden) setting and by pressure-pain threshold testing (PPT). Also rate of force development (RFD), force steadiness (FS), force precision (FP) and fatigue (F) are measured by using custom-made MATLAB programs. The strength tests are a part of an extensive physical examination by trained (and blinded) medical professionals at baseline and follow-up. Muscle activation level is measured by surface electromyography (EMG) (Nexus Mark 10, Mindmedia, Netherlands) on the forearm extensors, shoulder external rotator (Infraspinatus Mm.) and descending part of the trapezius muscle. Further, surface EEG (Nexus Mark 10, Mindmedia, Netherlands) will measure global brain activity during pre- and post testing by using a single a single sensor placement on the forehead (Fpz).'}], 'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'change from baseline to week 10', 'description': 'The change in "pain intensity during the last week" (average value of back, neck, shoulder, elbow and hand) from baseline to 10 week follow-up between the individually tailored biopsychosocial group and reference group. 2-way analysis of variance with repeated measures will be used, with time, group and time x group as fixed factors and subject as random factor. Analyses will be controlled for pain intensity at baseline.'}], 'secondaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'change from baseline to week 10', 'description': 'Cohens perceived stress scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Disorders', 'Stress']}, 'referencesModule': {'references': [{'pmid': '26431123', 'type': 'DERIVED', 'citation': 'Jay K, Brandt M, Hansen K, Sundstrup E, Jakobsen MD, Schraefel MC, Sjogaard G, Andersen LL. Effect of Individually Tailored Biopsychosocial Workplace Interventions on Chronic Musculoskeletal Pain and Stress Among Laboratory Technicians: Randomized Controlled Trial. Pain Physician. 2015 Sep-Oct;18(5):459-71.'}, {'pmid': '25519844', 'type': 'DERIVED', 'citation': 'Jay K, Brandt M, Sundstrup E, Schraefel M, Jakobsen MD, Sjogaard G, Andersen LL. Effect of individually tailored biopsychosocial workplace interventions on chronic musculoskeletal pain, stress and work ability among laboratory technicians: randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Dec 18;15:444. doi: 10.1186/1471-2474-15-444.'}]}, 'descriptionModule': {'briefSummary': 'Musculoskeletal disorders and stress of employees remain a major problem in many occupations. The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on musculoskeletal pain, work disability, and stress in lab technicians with a history of work-related musculoskeletal pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laboratory technician\n* Pain intensity \\>= 3 (scale of 0-10)\n* Pain duration \\>= 3 months\n* Pain frequency \\>= 3 days per week\n\nExclusion Criteria:\n\n* life threatening disease\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02047669', 'acronym': 'IRMA', 'briefTitle': 'Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Research Centre for the Working Environment, Denmark'}, 'officialTitle': 'Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians', 'orgStudyIdInfo': {'id': 'IRMA09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biopsychosocial', 'description': 'Biopsychosocial intervention with Individually tailored physical exercises and stress management', 'interventionNames': ['Behavioral: Biopsychosocial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': 'Reference group receiving "usual care" in terms of standard workplace ergonomics and physical exercises', 'interventionNames': ['Behavioral: Reference']}], 'interventions': [{'name': 'Biopsychosocial', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Biopsychosocial']}, {'name': 'Reference', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Reference']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'National Research Centre for the Working Environment', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lars L Andersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Centre for the Working Environment, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Centre for the Working Environment, Denmark', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'University of Southampton', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, PhD', 'investigatorFullName': 'Lars L. Andersen', 'investigatorAffiliation': 'National Research Centre for the Working Environment, Denmark'}}}}