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Completed

NCT Number: NCT03014128

Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics

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.

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Key information

Conditions

Musculoskeletal Diseases or Conditions Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aesculap AG

Tuttlingen, Baden-Wurttemberg, 78532, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical examination and data processing of questionnaires

Other

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Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

District Hospital, Tuttlingen

Other

Registry information

Acronym: PEIN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2017
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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