<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03014128</url>
  </required_header>
  <id_info>
    <org_study_id>PEIN-78532</org_study_id>
    <nct_id>NCT03014128</nct_id>
  </id_info>
  <brief_title>Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics</brief_title>
  <acronym>PEIN</acronym>
  <official_title>Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>District Hospital, Tuttlingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>District Hospital, Tuttlingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Work-related upper extremity musculoskeletal disorders (WRUEMSDs) have shown to be related to&#xD;
      many occupational situations and specific industries. However, there is conflicting&#xD;
      information about monotonous and repetitive activities. In this context, the profession of&#xD;
      surgical device mechanics has not been analyzed so far.&#xD;
&#xD;
      The objective of this study is to examine surgical device mechanics at different workplaces&#xD;
      with varying work contents and to compare them with a control group without the repetitive&#xD;
      workload exposition as described above. The headquarters and main production site of Aesculap&#xD;
      are located in Tuttlingen/Germany. Aesculap is the world leading manufacturer of surgical&#xD;
      devices.&#xD;
&#xD;
      After statistical power analysis, the investigators plan to randomize and include a total of&#xD;
      90 voluntary test persons in 3 groups (30 persons each). The study will include standardized&#xD;
      questionnaires and a physical examination as well as an industry test (Purdue Pegboard Test).&#xD;
&#xD;
      Primary and secondary endpoints were defined to show if significant difference between&#xD;
      surgical device mechanics and a control group is present.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">January 26, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)</measure>
    <time_frame>6 months</time_frame>
    <description>Validated questionnaire for upper extremity assessment (link in the reference section)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Range of wrist motion</measure>
    <time_frame>6 months</time_frame>
    <description>wrist extension/flexion, supination/pronation, ulnar/radial abduction (in degrees)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip force of the hand</measure>
    <time_frame>6 months</time_frame>
    <description>Hydraulic Hand Dynamometer (in kgs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Finger sensibility</measure>
    <time_frame>6 months</time_frame>
    <description>2-Point-Discrimination (in mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stenosing tenosynovitis</measure>
    <time_frame>6 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>De Quervain tenosynovitis</measure>
    <time_frame>6 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nerve entrapment syndromes</measure>
    <time_frame>6 months</time_frame>
    <description>Hoffmann's sign: tingling sensation triggered by a mechanical stimulus in the distal part of entrapped nerves (0=negative/no pathology, 1=positive/pathology)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carpal tunnel syndrome</measure>
    <time_frame>6 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tennis elbow (lateral epicondylitis)</measure>
    <time_frame>6 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Purdue Pegboard Test</measure>
    <time_frame>6 months</time_frame>
    <description>Standardized industrial test to examine uni- and bimanual skill (number of repetitions, point scale)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Musculoskeletal Diseases or Conditions</condition>
  <arm_group>
    <arm_group_label>Inspection and Packaging</arm_group_label>
    <description>self-descriptive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grinding, Polishing and Matting</arm_group_label>
    <description>self-descriptive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>All other employees at Aesculap (not in first 2 groups)</arm_group_label>
    <description>including administration and offices as well as all other mechanical workplaces</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical examination and data processing of questionnaires</intervention_name>
    <description>xy</description>
    <arm_group_label>All other employees at Aesculap (not in first 2 groups)</arm_group_label>
    <arm_group_label>Grinding, Polishing and Matting</arm_group_label>
    <arm_group_label>Inspection and Packaging</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Employees of the Aesculap AG, world leader in production of surgical devices&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  work ability without absence &gt; 2 weeks within the last 3 months&#xD;
&#xD;
          -  &gt;5 years on workplace or similar workplace when in group of surgical device mechanics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  spinal syndrome in history&#xD;
&#xD;
          -  chronic shoulder pain in history&#xD;
&#xD;
          -  congenital malformation of the upper extremity/hand&#xD;
&#xD;
          -  rheumatoid arthritis or fibromyalgia in history&#xD;
&#xD;
          -  actual hand therapy as conservative therapy or therapy after operation due to upper&#xD;
             extremity musculoskeletal pathology&#xD;
&#xD;
          -  previous operation(s) due to nerve entrapment syndrome or chronic musculoskeletal&#xD;
             pathology of the upper extremity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oliver Lotter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum Landkreis TUT, Zeppelinstraße 21, 78532Tuttlingen/Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aesculap AG</name>
      <address>
        <city>Tuttlingen</city>
        <state>BW</state>
        <zip>78532</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.dash.iwh.on.ca/about-dash</url>
    <description>Information about the &quot;Disabilities of the Arm, Shoulder and Hand Score (DASH)&quot;</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>musculoskeletal disorders</keyword>
  <keyword>upper extremity</keyword>
  <keyword>work</keyword>
  <keyword>surgical instruments</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014128
org study id: PEIN-78532
nct id: NCT03014128
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)
time frame: 6 months
description: Validated questionnaire for upper extremity assessment (link in the reference section)
measure: Range of wrist motion
time frame: 6 months
description: wrist extension/flexion, supination/pronation, ulnar/radial abduction (in degrees)
measure: Grip force of the hand
time frame: 6 months
description: Hydraulic Hand Dynamometer (in kgs)
measure: Finger sensibility
time frame: 6 months
description: 2-Point-Discrimination (in mm)
measure: Stenosing tenosynovitis
time frame: 6 months
description: 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)
measure: De Quervain tenosynovitis
time frame: 6 months
description: 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)
measure: Nerve entrapment syndromes
time frame: 6 months
description: Hoffmann's sign: tingling sensation triggered by a mechanical stimulus in the distal part of entrapped nerves (0=negative/no pathology, 1=positive/pathology)
measure: Carpal tunnel syndrome
time frame: 6 months
description: 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)
measure: Tennis elbow (lateral epicondylitis)
time frame: 6 months
description: 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)
measure: Purdue Pegboard Test
time frame: 6 months
description: Standardized industrial test to examine uni- and bimanual skill (number of repetitions, point scale)
arm group label: Inspection and Packaging
description: self-descriptive
arm group label: Grinding, Polishing and Matting
description: self-descriptive
arm group label: All other employees at Aesculap (not in first 2 groups)
description: including administration and offices as well as all other mechanical workplaces
intervention type: Other
intervention name: Clinical examination and data processing of questionnaires
description: xy
arm group label: All other employees at Aesculap (not in first 2 groups)
arm group label: Grinding, Polishing and Matting
arm group label: Inspection and Packaging
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Oliver Lotter, MD
role: Principal Investigator
affiliation: Klinikum Landkreis TUT, Zeppelinstraße 21, 78532Tuttlingen/Germany
facility: 
country: Germany
url: http://www.dash.iwh.on.ca/about-dash
description: Information about the "Disabilities of the Arm, Shoulder and Hand Score (DASH)"
responsible party type: Sponsor
mesh term: Musculoskeletal Diseases