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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
Vienna, Austria
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
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