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Acupuncture in Pediatrics and Adolescents with Chronic Inflammatory Bowel Diseases

Not Applicable
Recruiting
Conditions
Colitis, Ulcerative
Morbus Crohn
Interventions
Other: Acupuncture
Other: 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
Inclusion Criteria
  • mild/moderate CIBD
  • stable pharmacological treatment at least for 8 weeks
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Exclusion Criteria
  • complementary alternative medicine
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Acupuncture groupAcupuncture20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16).
Placebo groupPlacebo-Acupuncture20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).
Primary Outcome Measures
NameTimeMethod
Disease Activity IndexAt 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
NameTimeMethod
LeukocytesAt beginning vs 8 weeks

As another parameter of inflammation the leukocytes will be measured in 10\^9/L

C reactive proteinAt beginning vs 8 weeks

As one parameter of inflammation the C reactive protein will be measured in mg/dl.

Erythrocyte sedimentation rateAt 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 ILKAt 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 assessmentAt 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

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