<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/NCT04488198</url>
  </required_header>
  <id_info>
    <org_study_id>1773/2018</org_study_id>
    <nct_id>NCT04488198</nct_id>
  </id_info>
  <brief_title>Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases</brief_title>
  <official_title>Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      Chronic inflammatory bowel disease (CIBD) with its prevalence of 2.6 million people in Europe&#xD;
      is diagnosed in 25% before the age of 18 years. Early remission is intended to improve child&#xD;
      growth, quality of life and reduce psychological comorbidities. Additionally to conventional&#xD;
      drugs one third of pediatric CIBD patients use alternative treatment strategies. However,&#xD;
      there is a lack of evidence of acupuncture as complementary medicine in pediatric CIBD on the&#xD;
      disease activity and inflammation. Therefore, the main aim of this study is to evaluate the&#xD;
      effect of acupuncture in children with CIBD on the Pediatric Ulcerative Colitis Activity&#xD;
      Index (PUCAI) and the Weighted Pediatric Crohn's Disease Activity Index (sPCDAI), which are&#xD;
      non-invasive validated instruments to measure the disease activity. Furthermore, this study&#xD;
      aims to investigate the effect of acupuncture on chronic pain, quality of life and parameters&#xD;
      of inflammation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease Activity Index</measure>
    <time_frame>At beginning vs 8 weeks</time_frame>
    <description>Disease Activity Index (either Paediatric Ulcerative Colitis Activity Index in case of patients with ulcerative colitis or Weighted Pediatric Crohn's Disease Activity in patients with Crohn's disease)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Activity Index</measure>
    <time_frame>At beginning vs 4 weeks</time_frame>
    <description>Disease Activity Index (either Paediatric Ulcerative Colitis Activity Index in case of patients with ulcerative colitis or Weighted Pediatric Crohn's Disease Activity in patients with Crohn's disease)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in Children and Adolescents measured by KINDL(R)</measure>
    <time_frame>At beginning vs 4 weeks</time_frame>
    <description>The quality of life will be measured using the KINDL(R) questionnaire. The data will be transformed according to the manual of the questionnaire. The total score of quality of life ranges from 0 to 100. A higher score is associated with a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in Children and Adolescents measured by KINDL(R)</measure>
    <time_frame>At beginning vs 8 weeks</time_frame>
    <description>The quality of life will be measured using the KINDL(R) questionnaire. The data will be transformed according to the manual of the questionnaire. The total score of quality of life ranges from 0 to 100. A higher score is associated with a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in Children and Adolescents measured by ILK</measure>
    <time_frame>At beginning vs 4 weeks</time_frame>
    <description>The quality of life will be also measured using the ILK questionnaire (Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen). The total score of quality ranges from 0 to 28. A higher score is associated with a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in Children and Adolescents measured by ILK</measure>
    <time_frame>At beginning vs 8 weeks</time_frame>
    <description>The quality of life will be also measured using the ILK questionnaire (Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen). The total score of quality ranges from 0 to 28. A higher score is associated with a better quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>At beginning vs 4 weeks</time_frame>
    <description>The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>At beginning vs 8 weeks</time_frame>
    <description>The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C reactive protein</measure>
    <time_frame>At beginning vs 4 weeks</time_frame>
    <description>As one parameter of inflammation the C reactive protein will be measured in mg/dl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C reactive protein</measure>
    <time_frame>At beginning vs 8 weeks</time_frame>
    <description>As one parameter of inflammation the C reactive protein will be measured in mg/dl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukocytes</measure>
    <time_frame>At beginning vs 4 weeks</time_frame>
    <description>As another parameter of inflammation the leukocytes will be measured in 10^9/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukocytes</measure>
    <time_frame>At beginning vs 8 weeks</time_frame>
    <description>As another parameter of inflammation the leukocytes will be measured in 10^9/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte sedimentation rate</measure>
    <time_frame>At beginning vs 4 weeks</time_frame>
    <description>As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte sedimentation rate</measure>
    <time_frame>At beginning vs 8 weeks</time_frame>
    <description>As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Morbus Crohn</condition>
  <condition>Colitis, Ulcerative</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>20 CIBD patients do not receive acupuncture or placebo-acupuncture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acupuncture group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.</description>
    <arm_group_label>Acupuncture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo-Acupuncture</intervention_name>
    <description>Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild/moderate CIBD&#xD;
&#xD;
          -  stable pharmacological treatment at least for 8 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  complementary alternative medicine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gisela Scharbert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MedUniVienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gisela Scharbert, MD, PhD</last_name>
    <phone>01 40400 41000</phone>
    <email>gisela.scharbert@meduniwien.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christina Hafner, MD, PhD</last_name>
    <phone>01 40400 41000</phone>
    <email>christina.hafner@meduniwien.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MedUniVienna</last_name>
      <phone>01 400400 41000</phone>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Gisela Scharbert</investigator_full_name>
    <investigator_title>Prof. Dr. Gisela Scharbert</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
  </condition_browse>
  <!-- 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/NCT04488198
org study id: 1773/2018
nct id: NCT04488198
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic inflammatory bowel disease (CIBD) with its prevalence of 2.6 million people in Europe
      is diagnosed in 25% before the age of 18 years. Early remission is intended to improve child
      growth, quality of life and reduce psychological comorbidities. Additionally to conventional
      drugs one third of pediatric CIBD patients use alternative treatment strategies. However,
      there is a lack of evidence of acupuncture as complementary medicine in pediatric CIBD on the
      disease activity and inflammation. Therefore, the main aim of this study is to evaluate the
      effect of acupuncture in children with CIBD on the Pediatric Ulcerative Colitis Activity
      Index (PUCAI) and the Weighted Pediatric Crohn's Disease Activity Index (sPCDAI), which are
      non-invasive validated instruments to measure the disease activity. Furthermore, this study
      aims to investigate the effect of acupuncture on chronic pain, quality of life and parameters
      of inflammation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Disease Activity Index
time frame: At beginning vs 8 weeks
description: Disease Activity Index (either Paediatric Ulcerative Colitis Activity Index in case of patients with ulcerative colitis or Weighted Pediatric Crohn's Disease Activity in patients with Crohn's disease)
measure: Disease Activity Index
time frame: At beginning vs 4 weeks
description: Disease Activity Index (either Paediatric Ulcerative Colitis Activity Index in case of patients with ulcerative colitis or Weighted Pediatric Crohn's Disease Activity in patients with Crohn's disease)
measure: Quality of Life in Children and Adolescents measured by KINDL(R)
time frame: At beginning vs 4 weeks
description: The quality of life will be measured using the KINDL(R) questionnaire. The data will be transformed according to the manual of the questionnaire. The total score of quality of life ranges from 0 to 100. A higher score is associated with a better quality of life.
measure: Quality of Life in Children and Adolescents measured by KINDL(R)
time frame: At beginning vs 8 weeks
description: The quality of life will be measured using the KINDL(R) questionnaire. The data will be transformed according to the manual of the questionnaire. The total score of quality of life ranges from 0 to 100. A higher score is associated with a better quality of life.
measure: Quality of Life in Children and Adolescents measured by ILK
time frame: At beginning vs 4 weeks
description: The quality of life will be also measured using the ILK questionnaire (Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen). The total score of quality ranges from 0 to 28. A higher score is associated with a better quality of life.
measure: Quality of Life in Children and Adolescents measured by ILK
time frame: At beginning vs 8 weeks
description: The quality of life will be also measured using the ILK questionnaire (Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen). The total score of quality ranges from 0 to 28. A higher score is associated with a better quality of life).
measure: Pain assessment
time frame: At beginning vs 4 weeks
description: The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).
measure: Pain assessment
time frame: At beginning vs 8 weeks
description: The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).
measure: C reactive protein
time frame: At beginning vs 4 weeks
description: As one parameter of inflammation the C reactive protein will be measured in mg/dl.
measure: C reactive protein
time frame: At beginning vs 8 weeks
description: As one parameter of inflammation the C reactive protein will be measured in mg/dl.
measure: Leukocytes
time frame: At beginning vs 4 weeks
description: As another parameter of inflammation the leukocytes will be measured in 10^9/L
measure: Leukocytes
time frame: At beginning vs 8 weeks
description: As another parameter of inflammation the leukocytes will be measured in 10^9/L
measure: Erythrocyte sedimentation rate
time frame: At beginning vs 4 weeks
description: As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
measure: Erythrocyte sedimentation rate
time frame: At beginning vs 8 weeks
description: As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
arm group label: Control group
arm group type: No Intervention
description: 20 CIBD patients do not receive acupuncture or placebo-acupuncture.
arm group label: Acupuncture group
arm group type: Active Comparator
description: 20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16).
arm group label: Placebo group
arm group type: Placebo Comparator
description: 20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).
intervention type: Other
intervention name: Acupuncture
description: Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.
arm group label: Acupuncture group
intervention type: Other
intervention name: Placebo-Acupuncture
description: Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.
arm group label: Placebo group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Gisela Scharbert, MD
role: Principal Investigator
affiliation: MedUniVienna
last name: Gisela Scharbert, MD, PhD
phone: 01 40400 41000
email: gisela.scharbert@meduniwien.ac.at
last name: Christina Hafner, MD, PhD
phone: 01 40400 41000
email: christina.hafner@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Gisela Scharbert
investigator title: Prof. Dr. Gisela Scharbert
mesh term: Inflammatory Bowel Diseases
mesh term: Colitis, Ulcerative