Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases

Medical University of Vienna

Status: Active, not recruiting

Conditions: Colitis, Ulcerative; Morbus Crohn

Treatments: Other: Acupuncture; Other: Placebo-Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04488198

1773/2018

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild/moderate CIBD
• stable pharmacological treatment at least for 8 weeks

Exclusion criteria

• complementary alternative medicine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Control group

No Intervention group

Description:

20 CIBD patients do not receive acupuncture or placebo-acupuncture.

Acupuncture group

Active Comparator group

Description:

20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16).

Treatment:

Other: Acupuncture

Placebo group

Placebo Comparator group

Description:

20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).

Treatment:

Other: Placebo-Acupuncture