Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics

Musculoskeletal Diseases or Conditions Clinical Trial

— PEIN  

Official title:

Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014128
• Other study ID #: PEIN-78532
• Status: Completed
• Start date: March 2, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: May 2019
• Source: District Hospital, Tuttlingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 31, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Musculoskeletal Diseases or Conditions

Intervention

Other:
• Clinical examination and data processing of questionnaires
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Locations

Country	Name	City	State
Germany	Aesculap AG	Tuttlingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
District Hospital, Tuttlingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)	Validated questionnaire for upper extremity assessment (link in the reference section)	6 months
Secondary	Range of wrist motion	wrist extension/flexion, supination/pronation, ulnar/radial abduction (in degrees)	6 months
Secondary	Grip force of the hand	Hydraulic Hand Dynamometer (in kgs)	6 months
Secondary	Finger sensibility	2-Point-Discrimination (in mm)	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Purdue Pegboard Test	Standardized industrial test to examine uni- and bimanual skill (number of repetitions, point scale)	6 months

External Links

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