Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases

Conditions
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Morbus Crohn, Colitis, Ulcerative

Intervention / Treatment
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* Other: Acupuncture
* Other: Placebo-Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild/moderate CIBD stable pharmacological treatment at least for 8 weeks Exclusion Criteria: complementary alternative medicine

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>20 CIBD patients do not receive acupuncture or placebo-acupuncture. | |
| Active Comparator: Acupuncture group<br>20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16). | Other: Acupuncture<br>* Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.<br>|
| Placebo Comparator: Placebo group<br>20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger). | Other: Placebo-Acupuncture<br>* Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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