xml: <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/NCT06004284</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar69</org_study_id>
      <nct_id>NCT06004284</nct_id>
    </id_info>
    <brief_title>Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality</brief_title>
    <official_title>Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to evaluate the effects of ergonomics training with exercises&#xD;
        applied on factory workers with low back pain on pain, functionality, sleep and fatigue.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was planned as a randomized controlled trial. Workers between the ages of 18 and 60&#xD;
        working in a plastic casting factory in Gebze/Kocaeli with back and low back pain will be&#xD;
        included in the study. Participants will be divided into two groups using a simple&#xD;
        randomization method. Ergonomics training will be given to the first group together with core&#xD;
        stabilization exercises; The second group will be given only ergonomics training. The&#xD;
        exercises they will do will be explained to the participants individually and will be&#xD;
        supported by an exercise brochure. Participants will be asked to do the given exercises 3&#xD;
        days a week and continue for 8 weeks. Follow-up of the given exercises will be done with the&#xD;
        exercise follow-up chart. Persons with psychological or physical disabilities who can&#xD;
        exercise regularly will not be included in the study. In order to collect data on the&#xD;
        sociodemographic characteristics of the participants, a personal information form will be&#xD;
        prepared by the researcher and the participants will be asked to fill in this form. In order&#xD;
        to collect data from the participants; &quot;McGill Pain Questionnaire (Short)&quot; and &quot;Visual Analog&#xD;
        Scale&quot; to collect information on pain; &quot;Fatigue Severity Scale&quot; will be used to determine&#xD;
        fatigue levels, &quot;Pittsburgh Sleep Quality Questionnaire&quot; will be used to determine sleep&#xD;
        quality, and &quot;Oswestry Low Back Pain Scale&quot; will be used to evaluate functionality. The&#xD;
        questionnaires will be repeated before and after the study. The data before and after the&#xD;
        intervention will be analyzed statistically.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>
      <intervention_model_description>Participants will be given exercise practices along with ergonomics training.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The McGill Pain Questionnaire (MPQ)</measure>
      <time_frame>10 weeks</time_frame>
      <description>McGill pain questionnaire-short form is used to evaluate patients' pain in terms of feeling and sensory. Pain level is defined with 15 words consisting of 11 sensory and 4 affective words. From these descriptive words, the patient should choose an answer that is compatible with him/her as &quot;no (0)&quot;, &quot;mild (1)&quot;, &quot;moderate (2)&quot;, &quot;severe (3)&quot;. In addition, the pain felt during the survey is measured with the VAS, and the total pain intensity of the pain is measured with a 6-point Likert scale. Pain is defined as &quot;absent (0)&quot; and &quot;unbearable (5)&quot; on the Likert scale. In total, pain scores between 0-45 (no pain=0, severe pain=45).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oswestry Low Back Pain Disability Questionnaire</measure>
      <time_frame>10 weeks</time_frame>
      <description>It was developed to measure the functionality of individuals. The scale determines functional disability for activities such as sitting, walking, personal care, lifting, social life, travel, and sleep. There are 10 questions in this scale. Each question has 6 options. Participants are asked to choose the definition that best describes their situation from these options. A score of 0-5 is assigned for each of the sentences, and the highest possible score is 50 points. It is evaluated as mild between 1 and 10 points, moderate between 11 and 30 points, and severe between 31 and 50 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue Severity Scale (FSS)</measure>
      <time_frame>10 weeks</time_frame>
      <description>This scale consists of 9 questions and each option has a score between 0-7. A score of 0 is expressed as &quot;strongly disagree&quot;, while a score of 7 is expressed as &quot;agree&quot;. The maximum score is 7, and it is recorded that people have a significant degree of fatigue for 4 points and above.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>10 weeks</time_frame>
      <description>Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of &quot;poor sleep quality&quot;.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Work-related Illness</condition>
    <condition>Work Accident</condition>
    <condition>Occupational Diseases</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Only ergonomics training will be given to the control group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be given training including stretching and core exercises along with ergonomics training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>control</intervention_name>
      <description>Ergonomics training will be given to each of the control group participants individually. The content of this training will include &quot;what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk fa</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise group</intervention_name>
      <description>The exercise training program will be applied for 8 weeks, 3 days a week and for an average of 20-30 minutes. After the maneuver is taught, stretching exercises lasting 5 minutes for warm-up purposes and posture and core exercises lasting 25 minutes will be taught. Among the stretching exercises, quadratus lumborum stretching, hamstring stretching, erector spina stretching, hip extensor stretching exercises will be applied. Posterior pelvic tilt exercise will be performed as a control and smoothing exercise for the vertebrae of the lumbar and pelvic region. Among the core stabilization exercises, bridging, plank, plank in side lying, abdominal strengthening, cross arm leg lifting exercises in crawling position will be performed. Each exercise position will be required to be maintained for 8 seconds and to do 10-15 repetitions.</description>
      <arm_group_label>exercise group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  be between the ages of 18-65,&#xD;
  &#xD;
            -  Having low back pain in the last 3 months&#xD;
  &#xD;
            -  Visual Pain Scale (VAS) &gt;4&#xD;
  &#xD;
            -  No surgical intervention in the last 6 months,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not being cooperative desk work&#xD;
  &#xD;
            -  Presence of psychological problems,&#xD;
  &#xD;
            -  Using sleeping pills&#xD;
  &#xD;
            -  Presence of neurological and orthopedic disease.&#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>Elif PEHLEVAN</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Üsküdar Unıversıty</name>
        <address>
          <city>Gebze</city>
          <state>Kocaeli</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ömer ŞEVGİN</last_name>
        <phone>+905069787535</phone>
        <email>omer.sevgin@uskudar.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Erick PN, Smith DR. A systematic review of musculoskeletal disorders among school teachers. BMC Musculoskelet Disord. 2011 Nov 17;12:260. doi: 10.1186/1471-2474-12-260.</citation>
      <PMID>22087739</PMID>
    </reference>
    <reference>
      <citation>Bell JA, Burnett A. Exercise for the primary, secondary and tertiary prevention of low back pain in the workplace: a systematic review. J Occup Rehabil. 2009 Mar;19(1):8-24. doi: 10.1007/s10926-009-9164-5. Epub 2009 Feb 14.</citation>
      <PMID>19219537</PMID>
    </reference>
    <reference>
      <citation>Biman S, Maharana S, Metri KG, Nagaratna R. Effects of yoga on stress, fatigue, musculoskeletal pain, and the quality of life among employees of diamond industry: A new approach in employee wellness. Work. 2021;70(2):521-529. doi: 10.3233/WOR-213589.</citation>
      <PMID>34633352</PMID>
    </reference>
    <reference>
      <citation>Coulombe BJ, Games KE, Neil ER, Eberman LE. Core Stability Exercise Versus General Exercise for Chronic Low Back Pain. J Athl Train. 2017 Jan;52(1):71-72. doi: 10.4085/1062-6050-51.11.16. Epub 2016 Nov 16.</citation>
      <PMID>27849389</PMID>
    </reference>
    <reference>
      <citation>Abdollahi T, Pedram Razi S, Pahlevan D, Yekaninejad MS, Amaniyan S, Leibold Sieloff C, Vaismoradi M. Effect of an Ergonomics Educational Program on Musculoskeletal Disorders in Nursing Staff Working in the Operating Room: A Quasi-Randomized Controlled Clinical Trial. Int J Environ Res Public Health. 2020 Oct 8;17(19):7333. doi: 10.3390/ijerph17197333.</citation>
      <PMID>33049927</PMID>
    </reference>
    <reference>
      <citation>Jaromi M, Nemeth A, Kranicz J, Laczko T, Betlehem J. Treatment and ergonomics training of work-related lower back pain and body posture problems for nurses. J Clin Nurs. 2012 Jun;21(11-12):1776-84. doi: 10.1111/j.1365-2702.2012.04089.x.</citation>
      <PMID>22594388</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <keyword>Workers</keyword>
    <keyword>pain</keyword>
    <keyword>exercise</keyword>
    <keyword>ergonomics</keyword>
    <keyword>Functionality</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Occupational Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004284
  org study id: Uskudar69
  nct id: NCT06004284
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the effects of ergonomics training with exercises
        applied on factory workers with low back pain on pain, functionality, sleep and fatigue.
  The study was planned as a randomized controlled trial. Workers between the ages of 18 and 60
        working in a plastic casting factory in Gebze/Kocaeli with back and low back pain will be
        included in the study. Participants will be divided into two groups using a simple
        randomization method. Ergonomics training will be given to the first group together with core
        stabilization exercises; The second group will be given only ergonomics training. The
        exercises they will do will be explained to the participants individually and will be
        supported by an exercise brochure. Participants will be asked to do the given exercises 3
        days a week and continue for 8 weeks. Follow-up of the given exercises will be done with the
        exercise follow-up chart. Persons with psychological or physical disabilities who can
        exercise regularly will not be included in the study. In order to collect data on the
        sociodemographic characteristics of the participants, a personal information form will be
        prepared by the researcher and the participants will be asked to fill in this form. In order
        to collect data from the participants; "McGill Pain Questionnaire (Short)" and "Visual Analog
        Scale" to collect information on pain; "Fatigue Severity Scale" will be used to determine
        fatigue levels, "Pittsburgh Sleep Quality Questionnaire" will be used to determine sleep
        quality, and "Oswestry Low Back Pain Scale" will be used to evaluate functionality. The
        questionnaires will be repeated before and after the study. The data before and after the
        intervention will be analyzed statistically.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be given exercise practices along with ergonomics training.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The McGill Pain Questionnaire (MPQ)
  time frame: 10 weeks
  description: McGill pain questionnaire-short form is used to evaluate patients' pain in terms of feeling and sensory. Pain level is defined with 15 words consisting of 11 sensory and 4 affective words. From these descriptive words, the patient should choose an answer that is compatible with him/her as "no (0)", "mild (1)", "moderate (2)", "severe (3)". In addition, the pain felt during the survey is measured with the VAS, and the total pain intensity of the pain is measured with a 6-point Likert scale. Pain is defined as "absent (0)" and "unbearable (5)" on the Likert scale. In total, pain scores between 0-45 (no pain=0, severe pain=45).
  measure: Oswestry Low Back Pain Disability Questionnaire
  time frame: 10 weeks
  description: It was developed to measure the functionality of individuals. The scale determines functional disability for activities such as sitting, walking, personal care, lifting, social life, travel, and sleep. There are 10 questions in this scale. Each question has 6 options. Participants are asked to choose the definition that best describes their situation from these options. A score of 0-5 is assigned for each of the sentences, and the highest possible score is 50 points. It is evaluated as mild between 1 and 10 points, moderate between 11 and 30 points, and severe between 31 and 50 points.
  measure: Fatigue Severity Scale (FSS)
  time frame: 10 weeks
  description: This scale consists of 9 questions and each option has a score between 0-7. A score of 0 is expressed as "strongly disagree", while a score of 7 is expressed as "agree". The maximum score is 7, and it is recorded that people have a significant degree of fatigue for 4 points and above.
  measure: The Pittsburgh Sleep Quality Index (PSQI)
  time frame: 10 weeks
  description: Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality".
  arm group label: control group
  arm group type: Active Comparator
  description: Only ergonomics training will be given to the control group.
  arm group label: exercise group
  arm group type: Experimental
  description: Participants will be given training including stretching and core exercises along with ergonomics training.
  intervention type: Other
  intervention name: control
  description: Ergonomics training will be given to each of the control group participants individually. The content of this training will include "what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk fa
  arm group label: control group
  intervention type: Other
  intervention name: exercise group
  description: The exercise training program will be applied for 8 weeks, 3 days a week and for an average of 20-30 minutes. After the maneuver is taught, stretching exercises lasting 5 minutes for warm-up purposes and posture and core exercises lasting 25 minutes will be taught. Among the stretching exercises, quadratus lumborum stretching, hamstring stretching, erector spina stretching, hip extensor stretching exercises will be applied. Posterior pelvic tilt exercise will be performed as a control and smoothing exercise for the vertebrae of the lumbar and pelvic region. Among the core stabilization exercises, bridging, plank, plank in side lying, abdominal strengthening, cross arm leg lifting exercises in crawling position will be performed. Each exercise position will be required to be maintained for 8 seconds and to do 10-15 repetitions.
  arm group label: exercise group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Elif PEHLEVAN
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Erick PN, Smith DR. A systematic review of musculoskeletal disorders among school teachers. BMC Musculoskelet Disord. 2011 Nov 17;12:260. doi: 10.1186/1471-2474-12-260.
  PMID: 22087739
  citation: Bell JA, Burnett A. Exercise for the primary, secondary and tertiary prevention of low back pain in the workplace: a systematic review. J Occup Rehabil. 2009 Mar;19(1):8-24. doi: 10.1007/s10926-009-9164-5. Epub 2009 Feb 14.
  PMID: 19219537
  citation: Biman S, Maharana S, Metri KG, Nagaratna R. Effects of yoga on stress, fatigue, musculoskeletal pain, and the quality of life among employees of diamond industry: A new approach in employee wellness. Work. 2021;70(2):521-529. doi: 10.3233/WOR-213589.
  PMID: 34633352
  citation: Coulombe BJ, Games KE, Neil ER, Eberman LE. Core Stability Exercise Versus General Exercise for Chronic Low Back Pain. J Athl Train. 2017 Jan;52(1):71-72. doi: 10.4085/1062-6050-51.11.16. Epub 2016 Nov 16.
  PMID: 27849389
  citation: Abdollahi T, Pedram Razi S, Pahlevan D, Yekaninejad MS, Amaniyan S, Leibold Sieloff C, Vaismoradi M. Effect of an Ergonomics Educational Program on Musculoskeletal Disorders in Nursing Staff Working in the Operating Room: A Quasi-Randomized Controlled Clinical Trial. Int J Environ Res Public Health. 2020 Oct 8;17(19):7333. doi: 10.3390/ijerph17197333.
  PMID: 33049927
  citation: Jaromi M, Nemeth A, Kranicz J, Laczko T, Betlehem J. Treatment and ergonomics training of work-related lower back pain and body posture problems for nurses. J Clin Nurs. 2012 Jun;21(11-12):1776-84. doi: 10.1111/j.1365-2702.2012.04089.x.
  PMID: 22594388
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: assistant professor
  mesh term: Occupational Diseases
  sharing ipd: No