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/NCT06003842</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar73</org_study_id>
      <nct_id>NCT06003842</nct_id>
    </id_info>
    <brief_title>The Effect of Kinesio® Tex Application on Pain, Functionality, Sleep Quality and Work Performance in Drivers</brief_title>
    <official_title>The Effect of Kinesio® Tex Application on Pain, Functionality, Sleep Quality and Work Performance in Drivers</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>
        This study was planned to examine the effect of Kinesio® Tex application on pain,&#xD;
        functionality, sleep quality and work performance in drivers experiencing neck-back pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        50 active drivers will be included in the study. The drivers included in the study will be&#xD;
        randomly divided into two groups as exercise group and taping group. The home exercise&#xD;
        program will be visually explained to both groups and the exercises will be sent to the&#xD;
        participants as video. Kinesio® Tex will also be applied to the banding group. Evaluations&#xD;
        will be made before treatment and after 6 weeks of treatment. Within the scope of the&#xD;
        evaluation, demographic information of the patients, work experience, daily working time,&#xD;
        dominant hand, education information (university / high school), type of vehicle used, habit&#xD;
        of leaning elbow on the left window, diseases and drugs used, smoking and alcohol use, given&#xD;
        after mutual interview will be obtained by recording the answers. Joint range of motion,&#xD;
        manual muscle test, pain severity of the individuals participating in the study with the&#xD;
        Visual Analog Scale, neck functionality assessment with the Neck Disability Indicator, back&#xD;
        functionality assessment with the Quebec Back-Low Back Pain Disability Scale, sleep quality&#xD;
        assessment with the Pittsburgh Sleep Quality Index, work performance assessment To be&#xD;
        assessed by the Work Role Functioning Questionnaire&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 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>Two different Kinesio® Tex taping techniques were applied to the participants. One of these applications is for the upper trapezius muscle and the other is a taping technique applied to support the correct postural posture and trapezius muscle. Banding was applied bilaterally.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Neck Pain Disability Index Questionnaire</measure>
      <time_frame>8 weeks</time_frame>
      <description>The scale includes 10 titles. It includes pain sensitivity, heavy lifting, personal hygiene, reading, sleep, headache, concentration, work, driving, social activities. There are 6 answer options according to the severity of the limitation or pain. Scoring is between 0 and 5. The highest score is 50 and the least is 0. The neck disability level classification according to the total score is as follows 0-4: no restrictions 5-14: mild limitation 15-24: moderate limitation 25-34: severe limitation 34 and up: completely restricted</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Quebec Back Pain Disability Scale (QBPDS)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The problems caused by back pain are evaluated with 20 different activities from the scale. Its rating is between 0-5. 0 points are expressed as &quot;not difficult at all&quot; and 5 points are expressed as &quot;it is not possible to do&quot;. The total score is obtained by summing the answers given to the 20 activities.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>8 weeks</time_frame>
      <description>In the evaluation of the Pittsburgh Sleep Quality Index, 18 items are included in the scoring. The scale has a total of 7 components: sleep duration, habitual sleep efficiency, subjective sleep quality, sleep delay, sleep disturbance, daytime dysfunction, and sleep medication use. Some of the components consist of a single item, while others consist of groupings of several items. Each item scores between 0-3 and the sum of the scores of the 7 components forms the PSQI score. The total score is between 0-21. A high total score indicates a low sleep quality. A total PSQI score of ≤5 indicates &quot;good sleep quality&quot;, and &gt;5 indicates &quot;poor sleep quality&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Work Role Functioning Questionnaire (WRFQ)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The scale evaluates the difficulties experienced by people while doing their jobs as a percentage of time. In addition, the questionnaire evaluates the effectiveness of the treatment applied. It has five sub-headings as work program (5 questions), Efficiency (7 questions), Physical (6 questions), Mental (6 questions) and Social status (3 questions). It is a scale with 27 questions in total. This scale assesses how often individuals have had difficulties while doing their jobs in the last four weeks. If the expression defined in the question is not related to the profession of the person, he is asked to mark the option &quot;It is not suitable for my profession&quot;.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Neck Pain</condition>
    <condition>Back Pain</condition>
    <condition>Occupational Diseases</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The exercise program to be given to the participants consists of stretching, strengthening and postural exercises for the muscles in the neck-back region. While doing the posture exercises, the participants will be asked to do the exercises in front of the mirror in order to correct the wrong postural posture and to provide relaxation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>taping group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the exercises, the Kinesio® Tex taping application will remain on the body for 4 days, and then it will be applied 6 times in total, with a 3-day break.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise</intervention_name>
      <description>Stretching exercises for flexion, extension, lateral flexion and rotation, upper trapezius, levator scapula and pectoralis major muscles will be applied in the maximum range of motion of the cervical region in three planes. To increase the mobility of the thoracic region, exercises for thoracic mobility will be given. Strengthening exercises will focus on the back muscles. The resistance of the exercises will be determined according to the individual capacities and strain levels of the participants, and it will be requested to increase the amount of resistance applied depending on the functional developments. You will be asked to perform the exercises twice a day, with 10 repetitions, for 6 weeks. Participants will be asked to hold the position for 3-5 seconds and return to the starting position while doing the strengthening exercises.</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>taping group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>taping</intervention_name>
      <description>After the Kinesio® Tex application, it will remain in the body for 4 days, and then it will be applied 6 times in total, with a 3-day break. It will be stated that the area to be banded should not contain substances such as cream, hair or oil. Upper Trapeze taping will be performed by applying one end of the Y tape to the upper trapeze and the other end to the lower part of the spina scapula, by affixing the tape to the head of the shoulder while standing upright, and keeping the participant's ear tilted towards the other ear as much as possible. Before attaching the rest of the tape, the participant will be asked to bring the shoulder blades closer together and stand upright. In this position, using a mechanical correction technique along the medial line of the scapula along the spine, the rest of the tape will be adhered as an I tape with 35-50% tension.</description>
      <arm_group_label>taping group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteering to participate in the study Having signed the voluntary consent form.&#xD;
  &#xD;
            -  Being between the ages of 25-55&#xD;
  &#xD;
            -  Working in home health services for at least 2 years&#xD;
  &#xD;
            -  Reporting symptoms of localized pain and discomfort in the neck-back region lasting at&#xD;
               least 1 week in the last 12 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The participant's wish to terminate the study&#xD;
  &#xD;
            -  Receiving physical therapy for neck-back pain in the last 3 months&#xD;
  &#xD;
            -  Findings such as pins and needles, numbness and tingling in the upper extremity&#xD;
  &#xD;
            -  Having an allergy to taping&#xD;
  &#xD;
            -  Presence of a known specific disease that may cause chronic neck-back pain (nerve root&#xD;
               compression, postoperative condition in the neck and shoulder regions, peripheral&#xD;
               entrapment neuropathy, cervical spine anomaly, severe neck trauma such as whiplash,&#xD;
               malignancy, migraine).&#xD;
  &#xD;
            -  Alcohol and drug addiction&#xD;
  &#xD;
            -  Psychological conditions that may cause physical burden and recent major operations&#xD;
  &#xD;
            -  Presence of a skin disease that will affect the neck and back area&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hakan ZENGİ</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>İstanbul Büyükşehir Belediyesi</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Hakan ZENGİ</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Pope MH, Goh KL, Magnusson ML. Spine ergonomics. Annu Rev Biomed Eng. 2002;4:49-68. doi: 10.1146/annurev.bioeng.4.092101.122107. Epub 2002 Mar 22.</citation>
      <PMID>12117750</PMID>
    </reference>
    <reference>
      <citation>Rehn B, Nilsson T, Lundstrom R, Hagberg M, Burstrom L. Neck pain combined with arm pain among professional drivers of forest machines and the association with whole-body vibration exposure. Ergonomics. 2009 Oct;52(10):1240-7. doi: 10.1080/00140130902939889.</citation>
      <PMID>19787503</PMID>
    </reference>
    <reference>
      <citation>Bovenzi M. A prospective cohort study of neck and shoulder pain in professional drivers. Ergonomics. 2015;58(7):1103-16. doi: 10.1080/00140139.2014.935487. Epub 2014 Jul 7.</citation>
      <PMID>24998325</PMID>
    </reference>
    <reference>
      <citation>Chapline JF, Ferguson SA, Lillis RP, Lund AK, Williams AF. Neck pain and head restraint position relative to the driver's head in rear-end collisions. Accid Anal Prev. 2000 Mar;32(2):287-97. doi: 10.1016/s0001-4575(99)00126-8.</citation>
      <PMID>10688485</PMID>
    </reference>
    <reference>
      <citation>Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio(R) Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22.</citation>
      <PMID>23088702</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 11, 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>taping</keyword>
    <keyword>Kinesio® Tex</keyword>
    <keyword>functionality</keyword>
    <keyword>work performance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neck Pain</mesh_term>
      <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/NCT06003842
  org study id: Uskudar73
  nct id: NCT06003842
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was planned to examine the effect of Kinesio® Tex application on pain,
        functionality, sleep quality and work performance in drivers experiencing neck-back pain.
  50 active drivers will be included in the study. The drivers included in the study will be
        randomly divided into two groups as exercise group and taping group. The home exercise
        program will be visually explained to both groups and the exercises will be sent to the
        participants as video. Kinesio® Tex will also be applied to the banding group. Evaluations
        will be made before treatment and after 6 weeks of treatment. Within the scope of the
        evaluation, demographic information of the patients, work experience, daily working time,
        dominant hand, education information (university / high school), type of vehicle used, habit
        of leaning elbow on the left window, diseases and drugs used, smoking and alcohol use, given
        after mutual interview will be obtained by recording the answers. Joint range of motion,
        manual muscle test, pain severity of the individuals participating in the study with the
        Visual Analog Scale, neck functionality assessment with the Neck Disability Indicator, back
        functionality assessment with the Quebec Back-Low Back Pain Disability Scale, sleep quality
        assessment with the Pittsburgh Sleep Quality Index, work performance assessment To be
        assessed by the Work Role Functioning Questionnaire
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two different Kinesio® Tex taping techniques were applied to the participants. One of these applications is for the upper trapezius muscle and the other is a taping technique applied to support the correct postural posture and trapezius muscle. Banding was applied bilaterally.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Neck Pain Disability Index Questionnaire
  time frame: 8 weeks
  description: The scale includes 10 titles. It includes pain sensitivity, heavy lifting, personal hygiene, reading, sleep, headache, concentration, work, driving, social activities. There are 6 answer options according to the severity of the limitation or pain. Scoring is between 0 and 5. The highest score is 50 and the least is 0. The neck disability level classification according to the total score is as follows 0-4: no restrictions 5-14: mild limitation 15-24: moderate limitation 25-34: severe limitation 34 and up: completely restricted
  measure: The Quebec Back Pain Disability Scale (QBPDS)
  time frame: 8 weeks
  description: The problems caused by back pain are evaluated with 20 different activities from the scale. Its rating is between 0-5. 0 points are expressed as "not difficult at all" and 5 points are expressed as "it is not possible to do". The total score is obtained by summing the answers given to the 20 activities.
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: 8 weeks
  description: In the evaluation of the Pittsburgh Sleep Quality Index, 18 items are included in the scoring. The scale has a total of 7 components: sleep duration, habitual sleep efficiency, subjective sleep quality, sleep delay, sleep disturbance, daytime dysfunction, and sleep medication use. Some of the components consist of a single item, while others consist of groupings of several items. Each item scores between 0-3 and the sum of the scores of the 7 components forms the PSQI score. The total score is between 0-21. A high total score indicates a low sleep quality. A total PSQI score of ≤5 indicates "good sleep quality", and >5 indicates "poor sleep quality".
  measure: Work Role Functioning Questionnaire (WRFQ)
  time frame: 8 weeks
  description: The scale evaluates the difficulties experienced by people while doing their jobs as a percentage of time. In addition, the questionnaire evaluates the effectiveness of the treatment applied. It has five sub-headings as work program (5 questions), Efficiency (7 questions), Physical (6 questions), Mental (6 questions) and Social status (3 questions). It is a scale with 27 questions in total. This scale assesses how often individuals have had difficulties while doing their jobs in the last four weeks. If the expression defined in the question is not related to the profession of the person, he is asked to mark the option "It is not suitable for my profession".
  arm group label: control group
  arm group type: Active Comparator
  description: The exercise program to be given to the participants consists of stretching, strengthening and postural exercises for the muscles in the neck-back region. While doing the posture exercises, the participants will be asked to do the exercises in front of the mirror in order to correct the wrong postural posture and to provide relaxation.
  arm group label: taping group
  arm group type: Experimental
  description: In addition to the exercises, the Kinesio® Tex taping application will remain on the body for 4 days, and then it will be applied 6 times in total, with a 3-day break.
  intervention type: Other
  intervention name: exercise
  description: Stretching exercises for flexion, extension, lateral flexion and rotation, upper trapezius, levator scapula and pectoralis major muscles will be applied in the maximum range of motion of the cervical region in three planes. To increase the mobility of the thoracic region, exercises for thoracic mobility will be given. Strengthening exercises will focus on the back muscles. The resistance of the exercises will be determined according to the individual capacities and strain levels of the participants, and it will be requested to increase the amount of resistance applied depending on the functional developments. You will be asked to perform the exercises twice a day, with 10 repetitions, for 6 weeks. Participants will be asked to hold the position for 3-5 seconds and return to the starting position while doing the strengthening exercises.
  arm group label: control group
  arm group label: taping group
  intervention type: Other
  intervention name: taping
  description: After the Kinesio® Tex application, it will remain in the body for 4 days, and then it will be applied 6 times in total, with a 3-day break. It will be stated that the area to be banded should not contain substances such as cream, hair or oil. Upper Trapeze taping will be performed by applying one end of the Y tape to the upper trapeze and the other end to the lower part of the spina scapula, by affixing the tape to the head of the shoulder while standing upright, and keeping the participant's ear tilted towards the other ear as much as possible. Before attaching the rest of the tape, the participant will be asked to bring the shoulder blades closer together and stand upright. In this position, using a mechanical correction technique along the medial line of the scapula along the spine, the rest of the tape will be adhered as an I tape with 35-50% tension.
  arm group label: taping group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Hakan ZENGİ
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  investigator: 
  country: Turkey
  citation: Pope MH, Goh KL, Magnusson ML. Spine ergonomics. Annu Rev Biomed Eng. 2002;4:49-68. doi: 10.1146/annurev.bioeng.4.092101.122107. Epub 2002 Mar 22.
  PMID: 12117750
  citation: Rehn B, Nilsson T, Lundstrom R, Hagberg M, Burstrom L. Neck pain combined with arm pain among professional drivers of forest machines and the association with whole-body vibration exposure. Ergonomics. 2009 Oct;52(10):1240-7. doi: 10.1080/00140130902939889.
  PMID: 19787503
  citation: Bovenzi M. A prospective cohort study of neck and shoulder pain in professional drivers. Ergonomics. 2015;58(7):1103-16. doi: 10.1080/00140139.2014.935487. Epub 2014 Jul 7.
  PMID: 24998325
  citation: Chapline JF, Ferguson SA, Lillis RP, Lund AK, Williams AF. Neck pain and head restraint position relative to the driver's head in rear-end collisions. Accid Anal Prev. 2000 Mar;32(2):287-97. doi: 10.1016/s0001-4575(99)00126-8.
  PMID: 10688485
  citation: Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio(R) Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22.
  PMID: 23088702
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: assistant professor
  mesh term: Neck Pain
  mesh term: Occupational Diseases
  sharing ipd: No