Acupuncture in Pediatrics and Adolescents with Chronic Inflammatory Bowel Diseases
- Conditions
- Colitis, UlcerativeMorbus Crohn
- Interventions
- Other: AcupunctureOther: Placebo-Acupuncture
- Registration Number
- NCT04488198
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- mild/moderate CIBD
- stable pharmacological treatment at least for 8 weeks
- complementary alternative medicine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture group Acupuncture 20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16). Placebo group Placebo-Acupuncture 20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).
- Primary Outcome Measures
Name Time Method Disease Activity Index At beginning vs 4 weeks 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
Name Time Method Leukocytes At beginning vs 8 weeks As another parameter of inflammation the leukocytes will be measured in 10\^9/L
C reactive protein At beginning vs 8 weeks As one parameter of inflammation the C reactive protein will be measured in mg/dl.
Erythrocyte sedimentation rate At beginning vs 8 weeks As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
Quality of Life in Children and Adolescents measured by KINDL(R) At beginning vs 8 weeks 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 At beginning vs 8 weeks 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 At beginning vs 8 weeks The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).
Trial Locations
- Locations (1)
Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
🇦🇹Vienna, Austria