<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/NCT03028051</url>
  </required_header>
  <id_info>
    <org_study_id>KROKIETA</org_study_id>
    <nct_id>NCT03028051</nct_id>
  </id_info>
  <brief_title>Chronic Pain, Life Style Factors and Quality of Life</brief_title>
  <official_title>Chronic Pain, Life Style Factors and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that&#xD;
      aims to analyze life style factors, socioeconomic and psychometric properties, metabolic&#xD;
      problems, drug use, quality of life and biochemical variables in chronic non-cancer pain&#xD;
      patients. The life style factors will be compared to those of normal population. At baseline,&#xD;
      the study patients fill in questionnaires (A-E), the patients´ weight, length, waist and&#xD;
      blood pressure are measured, pain-related factors are recorded and blood samples taken.&#xD;
      Changes in the quality of life of the study patients will be evaluated by questionnaires&#xD;
      during follow-up at 2 years and 5 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pain co-occurs with risk factors for cardiovascular diseases, depression, smoking and&#xD;
      sleep problems. Nutrition and low physical activity may predispose to chronic pain. To gain&#xD;
      information on the life style factors of adult chronic pain patients referred to university&#xD;
      hospital or central hospital pain clinics in Finland, 477 patients have been recruited to the&#xD;
      study. The patients fill in questionnaires on sociodemographic factors, pain, medication, use&#xD;
      of health services, physical activity, smoking, use of alcohol or other substances, sleep,&#xD;
      quality of life, nutrition and psychological factors at their first visit to the pain clinic.&#xD;
      Height, weight, waist circumference, blood pressure and pulse are measured by the study&#xD;
      nurse. A blood sample for analysis of blood sugar, cholesterol (total, LDL, HDL),&#xD;
      triglycerides, HbA1c and sensitive C-reactive protein (CRP) is taken. The pain clinician&#xD;
      records the pain diagnosis, medication and other methods of pain management chosen. The&#xD;
      patients will be sent follow-up questionnaires at 2 years and 5 years after baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of quality of life as assessed by 15 Dimensions questionnaire between baseline and 2 years</measure>
    <time_frame>2 years</time_frame>
    <description>Baseline and 2 years</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">477</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>chronic pain patients</arm_group_label>
    <description>Finnish speaking, adult chronic pain patients, aged 18 - 75 years, referred to pain clinic</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples frozen for possible further biochemical analysis (vitamin D, S-PTH, S-TSH,&#xD;
      cytokines, P-Ca++)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult, Finnish-speaking patients, aged 18-75 years, referred to a pain clinic for&#xD;
        multidisciplinary pain treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 to 75 years&#xD;
&#xD;
          -  chronic non-cancer pain&#xD;
&#xD;
          -  Finnish-speaking&#xD;
&#xD;
          -  referred to a multidisciplinary pain management center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to fill in questionnaires in Finnish&#xD;
&#xD;
          -  cancer pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eija Kalso, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Tarja Heiskanen</investigator_full_name>
    <investigator_title>MD, Ph.D., pain specialist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</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/NCT03028051
org study id: KROKIETA
nct id: NCT03028051
lead sponsor: 
has dmc: No
Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that
      aims to analyze life style factors, socioeconomic and psychometric properties, metabolic
      problems, drug use, quality of life and biochemical variables in chronic non-cancer pain
      patients. The life style factors will be compared to those of normal population. At baseline,
      the study patients fill in questionnaires (A-E), the patients´ weight, length, waist and
      blood pressure are measured, pain-related factors are recorded and blood samples taken.
      Changes in the quality of life of the study patients will be evaluated by questionnaires
      during follow-up at 2 years and 5 years.
Chronic pain co-occurs with risk factors for cardiovascular diseases, depression, smoking and
      sleep problems. Nutrition and low physical activity may predispose to chronic pain. To gain
      information on the life style factors of adult chronic pain patients referred to university
      hospital or central hospital pain clinics in Finland, 477 patients have been recruited to the
      study. The patients fill in questionnaires on sociodemographic factors, pain, medication, use
      of health services, physical activity, smoking, use of alcohol or other substances, sleep,
      quality of life, nutrition and psychological factors at their first visit to the pain clinic.
      Height, weight, waist circumference, blood pressure and pulse are measured by the study
      nurse. A blood sample for analysis of blood sugar, cholesterol (total, LDL, HDL),
      triglycerides, HbA1c and sensitive C-reactive protein (CRP) is taken. The pain clinician
      records the pain diagnosis, medication and other methods of pain management chosen. The
      patients will be sent follow-up questionnaires at 2 years and 5 years after baseline.
observational model: Cohort
time perspective: Prospective
measure: Change of quality of life as assessed by 15 Dimensions questionnaire between baseline and 2 years
time frame: 2 years
description: Baseline and 2 years
arm group label: chronic pain patients
description: Finnish speaking, adult chronic pain patients, aged 18 - 75 years, referred to pain clinic
Blood samples frozen for possible further biochemical analysis (vitamin D, S-PTH, S-TSH,
      cytokines, P-Ca++)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Eija Kalso, Professor
role: Principal Investigator
affiliation: Helsinki University Central Hospital
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Tarja Heiskanen
investigator title: MD, Ph.D., pain specialist
mesh term: Chronic Pain
sharing ipd: No