Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases

NCT ID: NCT04488198

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2026-12-31

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.

Detailed Description

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Conditions

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Morbus Crohn Colitis, Ulcerative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Acupuncture group

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

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo-Acupuncture

Intervention Type OTHER

Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.

Interventions

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Acupuncture

Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.

Intervention Type OTHER

Placebo-Acupuncture

Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* complementary alternative medicine
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Christina Hafner

Christina Hafner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gisela Scharbert, MD

Role: PRINCIPAL_INVESTIGATOR

MedUniVienna

Locations

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Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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1773/2018

Identifier Type: -

Identifier Source: org_study_id

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