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

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Diseases or Conditions
• Intervention / Treatment: Other: Clinical examination and data processing of questionnaires

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Germany
  • BW
    • Tuttlingen, BW, Germany, 78532
      • Aesculap AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Employees of the Aesculap AG, world leader in production of surgical devices

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inspection and Packaging; self-descriptive	Other: Clinical examination and data processing of questionnaires; xy
Grinding, Polishing and Matting; self-descriptive	Other: Clinical examination and data processing of questionnaires; xy
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; xy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)	Validated questionnaire for upper extremity assessment (link in the reference section)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of wrist motion	wrist extension/flexion, supination/pronation, ulnar/radial abduction (in degrees)	6 months
Grip force of the hand	Hydraulic Hand Dynamometer (in kgs)	6 months
Finger sensibility	2-Point-Discrimination (in mm)	6 months
Stenosing tenosynovitis	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)	6 months
De Quervain tenosynovitis	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 months
Nerve entrapment syndromes	Hoffmann's sign: tingling sensation triggered by a mechanical stimulus in the distal part of entrapped nerves (0=negative/no pathology, 1=positive/pathology)	6 months
Carpal tunnel syndrome	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)	6 months
Tennis elbow (lateral epicondylitis)	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)	6 months
Purdue Pegboard Test	Standardized industrial test to examine uni- and bimanual skill (number of repetitions, point scale)	6 months

Collaborators and Investigators

• Sponsor: District Hospital, Tuttlingen
• Investigators: Principal Investigator: Oliver Lotter, MD, Klinikum Landkreis TUT, Zeppelinstraße 21, 78532Tuttlingen/Germany

Publications and helpful links

Helpful Links

• Information about the "Disabilities of the Arm, Shoulder and Hand Score (DASH)"

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Actual): January 26, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: upper extremity; work; musculoskeletal disorders; surgical instruments
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: PEIN-78532