Musculoskeletal Diseases or ConditionsPEINNCT03014128
Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics
An observational study of Musculoskeletal Diseases or Conditions, run by District Hospital, Tuttlingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- What is being tested?
- Clinical examination and data processing of questionnaires
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2017to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Employees of the Aesculap AG, world leader in production of surgical devices
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Musculoskeletal Diseases or Conditions
- Being tested
- Clinical examination and data processing of questionnaires
- Keywords
- musculoskeletal disorders, upper extremity, work, surgical instruments
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination and data processing of questionnairesOther
xy
| Study group | Role | What they receive |
|---|---|---|
| Inspection and Packaging | self-descriptive Receives: Other: Clinical examination and data processing of questionnaires | |
| Grinding, Polishing and Matting | self-descriptive Receives: 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 Receives: Other: Clinical examination and data processing of questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)
Validated questionnaire for upper extremity assessment (link in the reference section)
Measured: 6 months
Secondary outcomes (9)
Range of wrist motion
wrist extension/flexion, supination/pronation, ulnar/radial abduction (in degrees)
Measured: 6 months
Grip force of the hand
Hydraulic Hand Dynamometer (in kgs)
Measured: 6 months
Finger sensibility
2-Point-Discrimination (in mm)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 months
Purdue Pegboard Test
Standardized industrial test to examine uni- and bimanual skill (number of repetitions, point scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start2 Mar 2017
- Primary completion26 Jan 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal Diseases or ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- District Hospital, Tuttlingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Lotter, MD, Principal investigator, Klinikum Landkreis TUT, Zeppelinstraße 21, 78532Tuttlingen/Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014128
- Sponsor's protocol ID
- PEIN-78532
- Acronym
- PEIN
- Status last verified
- May 2019
- First submitted
- 20 Dec 2016
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics
- ClinicalTrials.gov ID
- NCT03014128
- Acronym / sponsor ID
- PEIN / PEIN-78532
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- musculoskeletal disorders, upper extremity, work, surgical instruments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- District Hospital, TuttlingenUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inspection and Packaging | – | Other: Clinical examination and data processing of questionnairesself-descriptive |
| Grinding, Polishing and Matting | – | Other: Clinical examination and data processing of questionnairesself-descriptive |
| All other employees at Aesculap (not in first 2 groups) | – | Other: Clinical examination and data processing of questionnairesincluding administration and offices as well as all other mechanical workplaces |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Employees of the Aesculap AG, world leader in production of surgical devices
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examination and data processing of questionnairesxy | Other | All other employees at Aesculap (not in first 2 groups), Grinding, Polishing and Matting, Inspection and Packaging |
Primary outcome
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)
9 secondary outcomes
Range of wrist motion
Time frame: 6 months
Grip force of the hand
Time frame: 6 months
Finger sensibility
Time frame: 6 months
Stenosing tenosynovitis
Time frame: 6 months
De Quervain tenosynovitis
Time frame: 6 months
Nerve entrapment syndromes
Time frame: 6 months
Carpal tunnel syndrome
Time frame: 6 months
Tennis elbow (lateral epicondylitis)
Time frame: 6 months
Purdue Pegboard Test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Information about the "Disabilities of the Arm, Shoulder and Hand Score (DASH)"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Lotter, MD principal investigator
Klinikum Landkreis TUT, Zeppelinstraße 21, 78532Tuttlingen/Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases or Conditions, run by District Hospital, Tuttlingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.