Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-01-13 @ 12:13 PM
Study NCT ID:
NCT03014128
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2016-12-20', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)', 'timeFrame': '6 months', 'description': 'Validated questionnaire for upper extremity assessment (link in the reference section)'}], 'secondaryOutcomes': [{'measure': 'Range of wrist motion', 'timeFrame': '6 months', 'description': 'wrist extension/flexion, supination/pronation, ulnar/radial abduction (in degrees)'}, {'measure': 'Grip force of the hand', 'timeFrame': '6 months', 'description': 'Hydraulic Hand Dynamometer (in kgs)'}, {'measure': 'Finger sensibility', 'timeFrame': '6 months', 'description': '2-Point-Discrimination (in mm)'}, {'measure': 'Stenosing tenosynovitis', 'timeFrame': '6 months', 'description': 'Clinical test, focussing on areas of pain, smoothness of finger motion, evidence of locking (= trigger finger) and presence of lump in the palm (0=negative/no pathology, 1=positive/pathology)'}, {'measure': 'De Quervain tenosynovitis', 'timeFrame': '6 months', 'description': 'Clinical test, focussing on pain on thumb and wrist movement, focal tenderness and swelling over radial styloid, positive Finkelstein test (pain on passive ulnar deviation) and triggering or crepitus (0=negative/no pathology, 1=positive/pathology)'}, {'measure': 'Nerve entrapment syndromes', 'timeFrame': '6 months', 'description': "Hoffmann's sign: tingling sensation triggered by a mechanical stimulus in the distal part of entrapped nerves (0=negative/no pathology, 1=positive/pathology)"}, {'measure': 'Carpal tunnel syndrome', 'timeFrame': '6 months', 'description': 'Phalen maneuver: the test person is asked to hold the wrist in complete and forced flexion for 60 seconds. This provokes symptoms characteristic for carpal tunnel syndrome such as burning, tingling or numb sensation over the thumb, index, middle and ring fingers (0=negative/no pathology, 1=positive/pathology)'}, {'measure': 'Tennis elbow (lateral epicondylitis)', 'timeFrame': '6 months', 'description': "Maudsley's test (= middle finger test): the examiner resists extension of the 3rd digit of the hand, stressing the extensor digitorum muscle and tendon, while palpating the test person's lateral epicondyle (0=negative/no pathology, 1=positive/pathology)"}, {'measure': 'Purdue Pegboard Test', 'timeFrame': '6 months', 'description': 'Standardized industrial test to examine uni- and bimanual skill (number of repetitions, point scale)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['musculoskeletal disorders', 'upper extremity', 'work', 'surgical instruments'], 'conditions': ['Musculoskeletal Diseases or Conditions']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.dash.iwh.on.ca/about-dash', 'label': 'Information about the "Disabilities of the Arm, Shoulder and Hand Score (DASH)"'}]}, 'descriptionModule': {'briefSummary': 'Work-related upper extremity musculoskeletal disorders (WRUEMSDs) have shown to be related to many occupational situations and specific industries. However, there is conflicting information about monotonous and repetitive activities. In this context, the profession of surgical device mechanics has not been analyzed so far.\n\nThe objective of this study is to examine surgical device mechanics at different workplaces with varying work contents and to compare them with a control group without the repetitive workload exposition as described above. The headquarters and main production site of Aesculap are located in Tuttlingen/Germany. Aesculap is the world leading manufacturer of surgical devices.\n\nAfter statistical power analysis, the investigators plan to randomize and include a total of 90 voluntary test persons in 3 groups (30 persons each). The study will include standardized questionnaires and a physical examination as well as an industry test (Purdue Pegboard Test).\n\nPrimary and secondary endpoints were defined to show if significant difference between surgical device mechanics and a control group is present.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Employees of the Aesculap AG, world leader in production of surgical devices', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* work ability without absence \\> 2 weeks within the last 3 months\n* \\>5 years on workplace or similar workplace when in group of surgical device mechanics\n\nExclusion Criteria:\n\n* spinal syndrome in history\n* chronic shoulder pain in history\n* congenital malformation of the upper extremity/hand\n* rheumatoid arthritis or fibromyalgia in history\n* actual hand therapy as conservative therapy or therapy after operation due to upper extremity musculoskeletal pathology\n* previous operation(s) due to nerve entrapment syndrome or chronic musculoskeletal pathology of the upper extremity'}, 'identificationModule': {'nctId': 'NCT03014128', 'acronym': 'PEIN', 'briefTitle': 'Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics', 'organization': {'class': 'OTHER', 'fullName': 'District Hospital, Tuttlingen'}, 'officialTitle': 'Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics', 'orgStudyIdInfo': {'id': 'PEIN-78532'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inspection and Packaging', 'description': 'self-descriptive', 'interventionNames': ['Other: Clinical examination and data processing of questionnaires']}, {'label': 'Grinding, Polishing and Matting', 'description': 'self-descriptive', 'interventionNames': ['Other: Clinical examination and data processing of questionnaires']}, {'label': 'All other employees at Aesculap (not in first 2 groups)', 'description': 'including administration and offices as well as all other mechanical workplaces', 'interventionNames': ['Other: Clinical examination and data processing of questionnaires']}], 'interventions': [{'name': 'Clinical examination and data processing of questionnaires', 'type': 'OTHER', 'description': 'xy', 'armGroupLabels': ['All other employees at Aesculap (not in first 2 groups)', 'Grinding, Polishing and Matting', 'Inspection and Packaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78532', 'city': 'Tuttlingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Aesculap AG', 'geoPoint': {'lat': 47.98464, 'lon': 8.8177}}], 'overallOfficials': [{'name': 'Oliver Lotter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Landkreis TUT, Zeppelinstraße 21, 78532Tuttlingen/Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'District Hospital, Tuttlingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}