<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/NCT04417439</url>
  </required_header>
  <id_info>
    <org_study_id>ERamazanoglu</org_study_id>
    <nct_id>NCT04417439</nct_id>
  </id_info>
  <brief_title>The Effect of Acute Phase Treatment Approaches on Creatine Kinase and the Musculoskeletal System in Different Types of Burns</brief_title>
  <official_title>Turgut Özal Medical Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu 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>
      There are very few studies indicating the effect of acute phase treatment approaches on&#xD;
      creatine kinase and the musculoskeletal system in the physiotherapy and rehabilitation&#xD;
      process. Rehabilitation in burn patients is a benchmark due to return to pre-burn life.&#xD;
      Therefore, this study was conducted to determine the effect of acute phase treatment&#xD;
      approaches on creatine kinase and the musculoskeletal system in different types of burns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the literature, there are very few objective and quantitative studies comparing the&#xD;
      effects of standard wound care and rehabilitation period on different burn types in burn&#xD;
      patients. Thus, our study was designed to investigate the effects of acute phase treatment&#xD;
      approaches on creatine kinase and the musculoskeletal system in different types of burns.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2018</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 12, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>universal goniometer</measure>
    <time_frame>three weeks</time_frame>
    <description>Universal goniometer was used to measure arm flexion movement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A tape measure with a width of 7 mm</measure>
    <time_frame>three weeks</time_frame>
    <description>Anthropometric measurement (arm circumference measurement) was made with a tape measure of 7 mm width.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The biochemical examination of CK (creatine kinase)</measure>
    <time_frame>three weeks</time_frame>
    <description>Creatine kinase concentration in the blood was evaluated.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Burn Injury</condition>
  <arm_group>
    <arm_group_label>flame burns</arm_group_label>
    <description>The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>scald burns</arm_group_label>
    <description>The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>electrical burns</arm_group_label>
    <description>The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)</intervention_name>
    <description>The joint range of motion within the affected areas of burn patients was assessed by a universal goniometer. A 7-mm-wide tape measure was used to evaluate circumference measurement in individuals. The biochemical analysis of CK (creatine kinase) was performed by an expert on blood samples taken from patients in the hospital laboratories.</description>
    <arm_group_label>electrical burns</arm_group_label>
    <arm_group_label>flame burns</arm_group_label>
    <arm_group_label>scald burns</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 37 individuals, including 10 females and 27 males&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the study were being aged between 18-65 years and having different burn types, and&#xD;
             flame, scald, and electrical burns were included in the study.&#xD;
&#xD;
          -  The burn percentage and mortality percentage were calculated, and patients with a burn&#xD;
             percentage of less than fifty percent were included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the study were having a systemic disease, having substance abuse, and having a burn&#xD;
             percentage of more than fifty percent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Malatya İnönü University</name>
      <address>
        <city>Malatya</city>
        <zip>44000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turgut Özal medical center</name>
      <address>
        <city>Malatya</city>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Flores O, Tyack Z, Stockton K, Ware R, Paratz JD. Exercise training for improving outcomes post-burns: a systematic review and meta-analysis. Clin Rehabil. 2018 Jun;32(6):734-746. doi: 10.1177/0269215517751586. Epub 2018 Jan 10.</citation>
    <PMID>29320878</PMID>
  </reference>
  <reference>
    <citation>Goverman J, Mathews K, Goldstein R, Holavanahalli R, Kowalske K, Esselman P, Gibran N, Suman O, Herndon D, Ryan CM, Schneider JC. Adult Contractures in Burn Injury: A Burn Model System National Database Study. J Burn Care Res. 2017 Jan/Feb;38(1):e328-e336. doi: 10.1097/BCR.0000000000000380.</citation>
    <PMID>27380122</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Engin Ramazanoglu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Acute-phase burn</keyword>
  <keyword>Creatine Kinase, MM Form,</keyword>
  <keyword>Musculoskeletal Development</keyword>
  <keyword>Treatment Effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04417439
org study id: ERamazanoglu
nct id: NCT04417439
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There are very few studies indicating the effect of acute phase treatment approaches on
      creatine kinase and the musculoskeletal system in the physiotherapy and rehabilitation
      process. Rehabilitation in burn patients is a benchmark due to return to pre-burn life.
      Therefore, this study was conducted to determine the effect of acute phase treatment
      approaches on creatine kinase and the musculoskeletal system in different types of burns.
In the literature, there are very few objective and quantitative studies comparing the
      effects of standard wound care and rehabilitation period on different burn types in burn
      patients. Thus, our study was designed to investigate the effects of acute phase treatment
      approaches on creatine kinase and the musculoskeletal system in different types of burns.
observational model: Case-Control
time perspective: Prospective
measure: universal goniometer
time frame: three weeks
description: Universal goniometer was used to measure arm flexion movement.
measure: A tape measure with a width of 7 mm
time frame: three weeks
description: Anthropometric measurement (arm circumference measurement) was made with a tape measure of 7 mm width.
measure: The biochemical examination of CK (creatine kinase)
time frame: three weeks
description: Creatine kinase concentration in the blood was evaluated.
arm group label: flame burns
description: The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories.
arm group label: scald burns
description: The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories.
arm group label: electrical burns
description: The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories.
intervention type: Other
intervention name: universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)
description: The joint range of motion within the affected areas of burn patients was assessed by a universal goniometer. A 7-mm-wide tape measure was used to evaluate circumference measurement in individuals. The biochemical analysis of CK (creatine kinase) was performed by an expert on blood samples taken from patients in the hospital laboratories.
arm group label: electrical burns
arm group label: flame burns
arm group label: scald burns
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Turkey
citation: Flores O, Tyack Z, Stockton K, Ware R, Paratz JD. Exercise training for improving outcomes post-burns: a systematic review and meta-analysis. Clin Rehabil. 2018 Jun;32(6):734-746. doi: 10.1177/0269215517751586. Epub 2018 Jan 10.
PMID: 29320878
citation: Goverman J, Mathews K, Goldstein R, Holavanahalli R, Kowalske K, Esselman P, Gibran N, Suman O, Herndon D, Ryan CM, Schneider JC. Adult Contractures in Burn Injury: A Burn Model System National Database Study. J Burn Care Res. 2017 Jan/Feb;38(1):e328-e336. doi: 10.1097/BCR.0000000000000380.
PMID: 27380122
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Engin Ramazanoglu
investigator title: Principal Investigator
mesh term: Burns
sharing ipd: Undecided