<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/NCT03790514</url>
  </required_header>
  <id_info>
    <org_study_id>AksarayUTRH</org_study_id>
    <nct_id>NCT03790514</nct_id>
  </id_info>
  <brief_title>Heat Wrap for Renal Colic</brief_title>
  <official_title>Alternative Therapy for Pain Management in Patients With Renal Colic: Heat Wrap</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aksaray University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aksaray University Training and Research Hospital</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>
      Non-steroidal anti-inflammatory drugs (NSAIDs) (diclofenac, kotorolac, piroxicam) opioids&#xD;
      (petidine, tramadol, fentanyl), paracetamol and topical agents (EMLA, diclofenal gel), have&#xD;
      been shown to be effective in the treatment of renal colic . NSAIDs are commonly used to&#xD;
      treat renal colic, but they can reduce renal blood flow and cause kidney damage. In addition,&#xD;
      there are limitations in use in cases such as gastrointerstinal ulcers, hepatic insufficiency&#xD;
      and chronic obstructive pulmonary disease. Gastrointestinal complications (ulcers, reflux,&#xD;
      etc.) may cause hypersensitivity reactions (allergy) and coagulation disorders. On the other&#xD;
      hand, opioids may cause nausea, vomiting, hypotension, sedation, dizziness and even&#xD;
      respiratory depression. In addition to these pharmacological agents, stair-stroke, Turkish&#xD;
      bath, blanket or hot water bag and local warming are now used in the treatment of renal colic&#xD;
      in traditional methods.&#xD;
&#xD;
      Heat Wrap is an effective, natural solution designed to remove muscle pain with the help of&#xD;
      heat and used regularly by physical therapists. The heat wrap is activated by air contact&#xD;
      within a few minutes after its removal from its sheet and does not contain any drugs. It&#xD;
      contains heat from the active iron particles in contact with air. After a few minutes of&#xD;
      application, it begins to spread the natural, long-term (8 hours) heat by targeting the&#xD;
      source of the pain. The patient satisfaction is high because it is odorless and thin.&#xD;
&#xD;
      In the literature, considering the success of heat therapy in patients with renal colic (bath&#xD;
      entrance, electric blanket heating) in this study we have aimed to evaluate the efficacy of&#xD;
      alternative treatment with pain-relieving alternative treatments with little potential for&#xD;
      side effects and to see its applicability in daily treatment plans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Anticipated">March 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity Scale</measure>
    <time_frame>1 hour</time_frame>
    <description>Self reported pain intensity (VAS 0-10) after applying heat wrap. Each item is scored between 0-10. While 0 shos no pain, 10 is the greatest pain the patient has experienced</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Renal Colic</condition>
  <arm_group>
    <arm_group_label>Heat Wrap Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Heat Wrap</intervention_name>
    <description>Commercially heat tapes ( without drugs) will be applied to patients.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Heat Wrap Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients with renal colic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnants&#xD;
&#xD;
          -  Known allergies to heat tapes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Murat Gül</name>
      <address>
        <city>Aksaray</city>
        <zip>68000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Murat Gül</last_name>
      <phone>905056316913</phone>
      <email>drgulacademics@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aksaray University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Murat Gül</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Heat wrap</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colic</mesh_term>
    <mesh_term>Renal Colic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03790514
org study id: AksarayUTRH
nct id: NCT03790514
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Non-steroidal anti-inflammatory drugs (NSAIDs) (diclofenac, kotorolac, piroxicam) opioids
      (petidine, tramadol, fentanyl), paracetamol and topical agents (EMLA, diclofenal gel), have
      been shown to be effective in the treatment of renal colic . NSAIDs are commonly used to
      treat renal colic, but they can reduce renal blood flow and cause kidney damage. In addition,
      there are limitations in use in cases such as gastrointerstinal ulcers, hepatic insufficiency
      and chronic obstructive pulmonary disease. Gastrointestinal complications (ulcers, reflux,
      etc.) may cause hypersensitivity reactions (allergy) and coagulation disorders. On the other
      hand, opioids may cause nausea, vomiting, hypotension, sedation, dizziness and even
      respiratory depression. In addition to these pharmacological agents, stair-stroke, Turkish
      bath, blanket or hot water bag and local warming are now used in the treatment of renal colic
      in traditional methods.

      Heat Wrap is an effective, natural solution designed to remove muscle pain with the help of
      heat and used regularly by physical therapists. The heat wrap is activated by air contact
      within a few minutes after its removal from its sheet and does not contain any drugs. It
      contains heat from the active iron particles in contact with air. After a few minutes of
      application, it begins to spread the natural, long-term (8 hours) heat by targeting the
      source of the pain. The patient satisfaction is high because it is odorless and thin.

      In the literature, considering the success of heat therapy in patients with renal colic (bath
      entrance, electric blanket heating) in this study we have aimed to evaluate the efficacy of
      alternative treatment with pain-relieving alternative treatments with little potential for
      side effects and to see its applicability in daily treatment plans.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Intensity Scale
time frame: 1 hour
description: Self reported pain intensity (VAS 0-10) after applying heat wrap. Each item is scored between 0-10. While 0 shos no pain, 10 is the greatest pain the patient has experienced
arm group label: Heat Wrap Group
arm group type: Experimental
arm group label: Control Group
arm group type: Placebo Comparator
intervention type: Other
intervention name: Heat Wrap
description: Commercially heat tapes ( without drugs) will be applied to patients.
arm group label: Control Group
arm group label: Heat Wrap Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Aksaray University Training and Research Hospital
investigator full name: Murat Gül
investigator title: Assistant Professor
mesh term: Colic
mesh term: Renal Colic
sharing ipd: No