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Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics (PEIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03014128
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : May 6, 2019
Information provided by (Responsible Party):
District Hospital, Tuttlingen

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.

Condition or disease Intervention/treatment
Musculoskeletal Diseases or Conditions Other: Clinical examination and data processing of questionnaires

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : May 31, 2018

Group/Cohort Intervention/treatment
Inspection and Packaging
Other: Clinical examination and data processing of questionnaires

Grinding, Polishing and Matting
Other: Clinical examination and data processing of questionnaires

All other employees at Aesculap (not in first 2 groups)
including administration and offices as well as all other mechanical workplaces
Other: Clinical examination and data processing of questionnaires

Primary Outcome Measures :
  1. DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire) [ Time Frame: 6 months ]
    Validated questionnaire for upper extremity assessment (link in the reference section)

Secondary Outcome Measures :
  1. Range of wrist motion [ Time Frame: 6 months ]
    wrist extension/flexion, supination/pronation, ulnar/radial abduction (in degrees)

  2. Grip force of the hand [ Time Frame: 6 months ]
    Hydraulic Hand Dynamometer (in kgs)

  3. Finger sensibility [ Time Frame: 6 months ]
    2-Point-Discrimination (in mm)

  4. Stenosing tenosynovitis [ Time Frame: 6 months ]
    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)

  5. De Quervain tenosynovitis [ Time Frame: 6 months ]
    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)

  6. Nerve entrapment syndromes [ Time Frame: 6 months ]
    Hoffmann's sign: tingling sensation triggered by a mechanical stimulus in the distal part of entrapped nerves (0=negative/no pathology, 1=positive/pathology)

  7. Carpal tunnel syndrome [ Time Frame: 6 months ]
    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)

  8. Tennis elbow (lateral epicondylitis) [ Time Frame: 6 months ]
    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)

  9. Purdue Pegboard Test [ Time Frame: 6 months ]
    Standardized industrial test to examine uni- and bimanual skill (number of repetitions, point scale)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Employees of the Aesculap AG, world leader in production of surgical devices

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03014128

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Aesculap AG
Tuttlingen, BW, Germany, 78532
Sponsors and Collaborators
District Hospital, Tuttlingen
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Principal Investigator: Oliver Lotter, MD Klinikum Landkreis TUT, Zeppelinstraße 21, 78532Tuttlingen/Germany
Additional Information:
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Responsible Party: District Hospital, Tuttlingen Identifier: NCT03014128    
Other Study ID Numbers: PEIN-78532
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Keywords provided by District Hospital, Tuttlingen:
musculoskeletal disorders
upper extremity
surgical instruments
Additional relevant MeSH terms:
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Musculoskeletal Diseases