An interventional study of Acupuncture and Placebo-Acupuncture in Morbus Crohn and Colitis, Ulcerative, sponsored by Medical University of Vienna. Active, not recruiting at 1 site in Austria. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: Acupuncture
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 acupuncture needles.
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.
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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At beginning vs 8 weeks
C reactive protein
As one parameter of inflammation the C reactive protein will be measured in mg/dl.
Time frame: At beginning vs 4 weeks
C reactive protein
As one parameter of inflammation the C reactive protein will be measured in mg/dl.
Time frame: At beginning vs 8 weeks
Leukocytes
As another parameter of inflammation the leukocytes will be measured in 10\^9/L
Time frame: At beginning vs 4 weeks
Leukocytes
As another parameter of inflammation the leukocytes will be measured in 10\^9/L
Time frame: At beginning vs 8 weeks
Erythrocyte sedimentation rate
As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
Time frame: At beginning vs 4 weeks
Erythrocyte sedimentation rate
As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
Time frame: At beginning vs 8 weeks
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna