Colitis, Ulcerative, Morbus Crohn
Conditions
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.
Interventions
OTHERAcupuncture
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.
OTHERPlacebo-Acupuncture
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* mild/moderate CIBD * stable pharmacological treatment at least for 8 weeks
Exclusion criteria
* complementary alternative medicine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Index | At beginning vs 8 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in Children and Adolescents measured by ILK | At beginning vs 4 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 4 weeks | The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible). |
| Quality of Life in Children and Adolescents measured by KINDL(R) | At beginning vs 4 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. |
| Leukocytes | At beginning vs 4 weeks | As another parameter of inflammation the leukocytes will be measured in 10\^9/L |
| Erythrocyte sedimentation rate | At beginning vs 4 weeks | As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured. |
| C reactive protein | At beginning vs 4 weeks | As one parameter of inflammation the C reactive protein will be measured in mg/dl. |
Countries
Austria
Outcome results
None listed