Back to resultsAcupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases
Primary Purpose
Morbus Crohn, Colitis, Ulcerative
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Acupuncture
Placebo-Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Morbus Crohn
Eligibility Criteria
Inclusion Criteria:
- mild/moderate CIBD
- stable pharmacological treatment at least for 8 weeks
Exclusion Criteria:
- complementary alternative medicine
Sites / Locations
- Department of Anesthesia, General Intensive Care and Pain Management,Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Placebo Comparator
Arm Label
Control group
Acupuncture group
Placebo group
Arm Description
20 CIBD patients do not receive acupuncture or placebo-acupuncture.
20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16).
20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).
Outcomes
Primary Outcome Measures
Disease Activity Index
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)
Disease Activity Index
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)
Secondary Outcome Measures
Quality of Life in Children and Adolescents measured by KINDL(R)
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.
Quality of Life in Children and Adolescents measured by KINDL(R)
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.
Quality of Life in Children and Adolescents measured by ILK
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.
Quality of Life in Children and Adolescents measured by ILK
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).
Pain assessment
The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).
Pain assessment
The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).
C reactive protein
As one parameter of inflammation the C reactive protein will be measured in mg/dl.
C reactive protein
As one parameter of inflammation the C reactive protein will be measured in mg/dl.
Leukocytes
As another parameter of inflammation the leukocytes will be measured in 10^9/L
Leukocytes
As another parameter of inflammation the leukocytes will be measured in 10^9/L
Erythrocyte sedimentation rate
As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
Erythrocyte sedimentation rate
As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
Full Information
NCT ID
NCT04488198
First Posted
June 26, 2020
Last Updated
August 31, 2021
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04488198
Brief Title
Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases
Official Title
Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbus Crohn, Colitis, Ulcerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
20 CIBD patients do not receive acupuncture or placebo-acupuncture.
Arm Title
Acupuncture group
Arm Type
Active Comparator
Arm Description
20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.
Intervention Type
Other
Intervention Name(s)
Placebo-Acupuncture
Intervention Description
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.
Primary Outcome Measure Information:
Title
Disease Activity Index
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)
Time Frame
At beginning vs 8 weeks
Title
Disease Activity Index
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)
Time Frame
At beginning vs 4 weeks
Secondary Outcome Measure Information:
Title
Quality of Life in Children and Adolescents measured by KINDL(R)
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.
Time Frame
At beginning vs 4 weeks
Title
Quality of Life in Children and Adolescents measured by KINDL(R)
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.
Time Frame
At beginning vs 8 weeks
Title
Quality of Life in Children and Adolescents measured by ILK
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.
Time Frame
At beginning vs 4 weeks
Title
Quality of Life in Children and Adolescents measured by ILK
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).
Time Frame
At beginning vs 8 weeks
Title
Pain assessment
Description
The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).
Time Frame
At beginning vs 4 weeks
Title
Pain assessment
Description
The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).
Time Frame
At beginning vs 8 weeks
Title
C reactive protein
Description
As one parameter of inflammation the C reactive protein will be measured in mg/dl.
Time Frame
At beginning vs 4 weeks
Title
C reactive protein
Description
As one parameter of inflammation the C reactive protein will be measured in mg/dl.
Time Frame
At beginning vs 8 weeks
Title
Leukocytes
Description
As another parameter of inflammation the leukocytes will be measured in 10^9/L
Time Frame
At beginning vs 4 weeks
Title
Leukocytes
Description
As another parameter of inflammation the leukocytes will be measured in 10^9/L
Time Frame
At beginning vs 8 weeks
Title
Erythrocyte sedimentation rate
Description
As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
Time Frame
At beginning vs 4 weeks
Title
Erythrocyte sedimentation rate
Description
As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
Time Frame
At beginning vs 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild/moderate CIBD
stable pharmacological treatment at least for 8 weeks
Exclusion Criteria:
complementary alternative medicine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gisela Scharbert, MD, PhD
Phone
01 40400 41000
Email
gisela.scharbert@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Hafner, MD, PhD
Phone
01 40400 41000
Email
christina.hafner@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisela Scharbert, MD
Organizational Affiliation
MedUniVienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MedUniVienna
Phone
01 400400 41000
12. IPD Sharing Statement
Learn more about this trial
Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases
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