<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/NCT01671267</url>
  </required_header>
  <id_info>
    <org_study_id>IRMA06</org_study_id>
    <nct_id>NCT01671267</nct_id>
  </id_info>
  <brief_title>Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers</brief_title>
  <acronym>IRMA</acronym>
  <official_title>Implementation of Physical Exercise at the Workplace (IRMA06) - Slaughterhouse Workers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Research Centre for the Working Environment, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Research Centre for the Working Environment, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers,&#xD;
      allegedly due to the substantial load of these body regions during work. Work disability is a&#xD;
      common consequence of these pains. Lowering the physical exposure through ergonomic&#xD;
      intervention may be a strategy to reduce the workload. An alternative strategy could be to&#xD;
      increase the physical capacity through strength training of the shoulder-, arm- and&#xD;
      hand-muscles. This study investigates the effect of two contrasting interventions, i.e. load&#xD;
      reduction (ergonomic intervention) versus training of physical capacity (strength training)&#xD;
      on pain and work disability in slaughterhouse workers.&#xD;
&#xD;
      The main hypothesis is that strength training intervention for 10 weeks compared with&#xD;
      ergonomic intervention results in reduced pain of the shoulder, arm and hand.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>change from baseline to week 10</time_frame>
    <description>The change in &quot;pain intensity during the last week&quot; (average value of shoulder, elbow and hand) from baseline to 10 week follow-up between the strength training group and ergonomic group. The ergonomic group will be considered the reference group. 2-way analysis of variance (Proc Mixed of SAS) with repeated measures will be used, with time and group as fixed factors and subject as random factor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DASH</measure>
    <time_frame>change from baseline to week 10</time_frame>
    <description>Disability of the arm, shoulder and hand questionnaire (DASH). Only the work-module of DASH will be included. Analyzed the same way as the primary outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>PPT</measure>
    <time_frame>change from baseline to week 10</time_frame>
    <description>Pressure pain threshold of the muscle of the forearm, external rotators of the shoulder, and tibialis anterior of the leg (reference muscle).</description>
  </other_outcome>
  <other_outcome>
    <measure>WAI</measure>
    <time_frame>change from baseline to week 10</time_frame>
    <description>Work ability index questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Total tenderness score</measure>
    <time_frame>change from baseline to week 10</time_frame>
    <description>change in examiner-verified tenderness of the muscles of the shoulder, arm and hand. Scale of &quot;no&quot;, &quot;a little&quot;, &quot;moderate&quot; and &quot;severe&quot; tenderness. Summed up to a total tenderness score (Andersen LL 2011, PMID: 21177034)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Musculoskeletal Disorders</condition>
  <arm_group>
    <arm_group_label>Strength training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strength training of the shoulder, arm and hand muscles for 3 x 10 minutes a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ergonomic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receives counseling on workstation adjustment and optimal use of the work tools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strength training</intervention_name>
    <arm_group_label>Strength training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ergonomic</intervention_name>
    <arm_group_label>Ergonomic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Slaughterhouse worker&#xD;
&#xD;
          -  the pain should have lasted at least 3 months&#xD;
&#xD;
          -  pain intensity during the last three months of &gt;= 3 (scale 0-10) in the shoulder,&#xD;
             elbow or hand&#xD;
&#xD;
          -  the pain should be frequent (at least 3 days per week)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  life threatening disease&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars L Andersen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Research Centre for the Working Environment, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Research Centre for the Working Environment</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>January 26, 2014</last_update_submitted>
  <last_update_submitted_qc>January 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Research Centre for the Working Environment, Denmark</investigator_affiliation>
    <investigator_full_name>Lars L. Andersen</investigator_full_name>
    <investigator_title>Professor, PhD</investigator_title>
  </responsible_party>
  <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/NCT01671267
org study id: IRMA06
nct id: NCT01671267
lead sponsor: 
has dmc: No
The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers,
      allegedly due to the substantial load of these body regions during work. Work disability is a
      common consequence of these pains. Lowering the physical exposure through ergonomic
      intervention may be a strategy to reduce the workload. An alternative strategy could be to
      increase the physical capacity through strength training of the shoulder-, arm- and
      hand-muscles. This study investigates the effect of two contrasting interventions, i.e. load
      reduction (ergonomic intervention) versus training of physical capacity (strength training)
      on pain and work disability in slaughterhouse workers.

      The main hypothesis is that strength training intervention for 10 weeks compared with
      ergonomic intervention results in reduced pain of the shoulder, arm and hand.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain intensity
time frame: change from baseline to week 10
description: The change in "pain intensity during the last week" (average value of shoulder, elbow and hand) from baseline to 10 week follow-up between the strength training group and ergonomic group. The ergonomic group will be considered the reference group. 2-way analysis of variance (Proc Mixed of SAS) with repeated measures will be used, with time and group as fixed factors and subject as random factor.
measure: DASH
time frame: change from baseline to week 10
description: Disability of the arm, shoulder and hand questionnaire (DASH). Only the work-module of DASH will be included. Analyzed the same way as the primary outcome.
measure: PPT
time frame: change from baseline to week 10
description: Pressure pain threshold of the muscle of the forearm, external rotators of the shoulder, and tibialis anterior of the leg (reference muscle).
measure: WAI
time frame: change from baseline to week 10
description: Work ability index questionnaire
measure: Total tenderness score
time frame: change from baseline to week 10
description: change in examiner-verified tenderness of the muscles of the shoulder, arm and hand. Scale of "no", "a little", "moderate" and "severe" tenderness. Summed up to a total tenderness score (Andersen LL 2011, PMID: 21177034)
arm group label: Strength training
arm group type: Experimental
description: Strength training of the shoulder, arm and hand muscles for 3 x 10 minutes a week.
arm group label: Ergonomic
arm group type: Active Comparator
description: Receives counseling on workstation adjustment and optimal use of the work tools.
intervention type: Behavioral
intervention name: Strength training
arm group label: Strength training
intervention type: Behavioral
intervention name: Ergonomic
arm group label: Ergonomic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lars L Andersen, PhD
role: Principal Investigator
affiliation: National Research Centre for the Working Environment, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: National Research Centre for the Working Environment, Denmark
investigator full name: Lars L. Andersen
investigator title: Professor, PhD
mesh term: Musculoskeletal Diseases