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Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics

Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03014128
Acronym
PEIN
Enrollment
70
Registered
2017-01-09
Start date
2017-03-02
Completion date
2018-05-31
Last updated
2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Diseases or Conditions

Keywords

musculoskeletal disorders, upper extremity, work, surgical instruments

Brief summary

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. The 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. After 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). Primary and secondary endpoints were defined to show if significant difference between surgical device mechanics and a control group is present.

Interventions

OTHERClinical examination and data processing of questionnaires

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Sponsors

District Hospital, Tuttlingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-65 years of age * work ability without absence \> 2 weeks within the last 3 months * \>5 years on workplace or similar workplace when in group of surgical device mechanics

Exclusion criteria

* spinal syndrome in history * chronic shoulder pain in history * congenital malformation of the upper extremity/hand * rheumatoid arthritis or fibromyalgia in history * actual hand therapy as conservative therapy or therapy after operation due to upper extremity musculoskeletal pathology * previous operation(s) due to nerve entrapment syndrome or chronic musculoskeletal pathology of the upper extremity

Design outcomes

Primary

MeasureTime frameDescription
DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)6 monthsValidated questionnaire for upper extremity assessment (link in the reference section)

Secondary

MeasureTime frameDescription
Grip force of the hand6 monthsHydraulic Hand Dynamometer (in kgs)
Finger sensibility6 months2-Point-Discrimination (in mm)
Stenosing tenosynovitis6 monthsClinical 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)
De Quervain tenosynovitis6 monthsClinical 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)
Range of wrist motion6 monthswrist extension/flexion, supination/pronation, ulnar/radial abduction (in degrees)
Carpal tunnel syndrome6 monthsPhalen 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)
Tennis elbow (lateral epicondylitis)6 monthsMaudsley'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)
Purdue Pegboard Test6 monthsStandardized industrial test to examine uni- and bimanual skill (number of repetitions, point scale)
Nerve entrapment syndromes6 monthsHoffmann's sign: tingling sensation triggered by a mechanical stimulus in the distal part of entrapped nerves (0=negative/no pathology, 1=positive/pathology)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026