Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Colitis, Ulcerative; Morbus Crohn
• Intervention / Treatment: Other: Acupuncture; Other: Placebo-Acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gisela Scharbert, MD, PhD; Phone Number: 01 40400 41000; Email: gisela.scharbert@meduniwien.ac.at
• Study Contact Backup: Name: Christina Hafner, MD, PhD; Phone Number: 01 40400 41000; Email: christina.hafner@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
    • Contact: MedUniVienna; Phone Number: 01 400400 41000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• mild/moderate CIBD
• stable pharmacological treatment at least for 8 weeks

Exclusion Criteria:

• complementary alternative medicine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 20 CIBD patients do not receive acupuncture or placebo-acupuncture.
Active Comparator: Acupuncture group; 20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16).	Other: Acupuncture; Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.
Placebo Comparator: Placebo group; 20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).	Other: Placebo-Acupuncture; Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At beginning vs 8 weeks
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)	At beginning vs 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At beginning vs 4 weeks
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.	At beginning vs 8 weeks
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.	At beginning vs 4 weeks
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).	At beginning vs 8 weeks
Pain assessment	The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).	At beginning vs 4 weeks
Pain assessment	The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).	At beginning vs 8 weeks
C reactive protein	As one parameter of inflammation the C reactive protein will be measured in mg/dl.	At beginning vs 4 weeks
C reactive protein	As one parameter of inflammation the C reactive protein will be measured in mg/dl.	At beginning vs 8 weeks
Leukocytes	As another parameter of inflammation the leukocytes will be measured in 10^9/L	At beginning vs 4 weeks
Leukocytes	As another parameter of inflammation the leukocytes will be measured in 10^9/L	At beginning vs 8 weeks
Erythrocyte sedimentation rate	As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.	At beginning vs 4 weeks
Erythrocyte sedimentation rate	As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.	At beginning vs 8 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Gisela Scharbert, MD, MedUniVienna

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Colitis; Inflammatory Bowel Diseases; Colitis, Ulcerative
• Other Study ID Numbers: 1773/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No