Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases

Colitis, Ulcerative Clinical Trial

Official title:

Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04488198
• Other study ID #: 1773/2018
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: Gisela Scharbert, MD, PhD
• Phone: 01 40400 41000
• Email: gisela.scharbert[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• mild/moderate CIBD

• stable pharmacological treatment at least for 8 weeks

Exclusion Criteria:

• complementary alternative medicine

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Morbus Crohn

Intervention

Other:
• Acupuncture
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.
• Placebo-Acupuncture
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.

Locations

Country	Name	City	State
Austria	Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	C reactive protein	As one parameter of inflammation the C reactive protein will be measured in mg/dl.	At beginning vs 4 weeks
Secondary	C reactive protein	As one parameter of inflammation the C reactive protein will be measured in mg/dl.	At beginning vs 8 weeks
Secondary	Leukocytes	As another parameter of inflammation the leukocytes will be measured in 10^9/L	At beginning vs 4 weeks
Secondary	Leukocytes	As another parameter of inflammation the leukocytes will be measured in 10^9/L	At beginning vs 8 weeks
Secondary	Erythrocyte sedimentation rate	As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.	At beginning vs 4 weeks
Secondary	Erythrocyte sedimentation rate	As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.	At beginning vs 8 weeks