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Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases

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ClinicalTrials.gov Identifier: NCT04488198
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Gisela Scharbert, 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.

Condition or disease Intervention/treatment Phase
Morbus Crohn Colitis, Ulcerative Other: Acupuncture Other: Placebo-Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
20 CIBD patients do not receive acupuncture or placebo-acupuncture.
Active Comparator: Acupuncture group
20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16).
Other: Acupuncture
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.

Placebo Comparator: Placebo group
20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).
Other: Placebo-Acupuncture
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.




Primary Outcome Measures :
  1. Disease Activity Index [ Time Frame: 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)

  2. Disease Activity Index [ Time Frame: At 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 :
  1. Quality of Life in Children and Adolescents measured by KINDL(R) [ Time Frame: 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.

  2. Quality of Life in Children and Adolescents measured by KINDL(R) [ Time Frame: 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.

  3. Quality of Life in Children and Adolescents measured by ILK [ Time Frame: 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.

  4. Quality of Life in Children and Adolescents measured by ILK [ Time Frame: At 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).

  5. Pain assessment [ Time Frame: 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).

  6. Pain assessment [ Time Frame: At beginning vs 8 weeks ]
    The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).

  7. C reactive protein [ Time Frame: At beginning vs 4 weeks ]
    As one parameter of inflammation the C reactive protein will be measured in mg/dl.

  8. C reactive protein [ Time Frame: At beginning vs 8 weeks ]
    As one parameter of inflammation the C reactive protein will be measured in mg/dl.

  9. Leukocytes [ Time Frame: At beginning vs 4 weeks ]
    As another parameter of inflammation the leukocytes will be measured in 10^9/L

  10. Leukocytes [ Time Frame: At beginning vs 8 weeks ]
    As another parameter of inflammation the leukocytes will be measured in 10^9/L

  11. Erythrocyte sedimentation rate [ Time Frame: At beginning vs 4 weeks ]
    As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.

  12. Erythrocyte sedimentation rate [ Time Frame: At beginning vs 8 weeks ]
    As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • complementary alternative medicine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488198


Contacts
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Contact: Gisela Scharbert, MD, PhD 01 40400 41000 gisela.scharbert@meduniwien.ac.at
Contact: Christina Hafner, MD, PhD 01 40400 41000 christina.hafner@meduniwien.ac.at

Locations
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Austria
Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: MedUniVienna    01 400400 41000      
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Gisela Scharbert, MD MedUniVienna
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Responsible Party: Gisela Scharbert, Prof. Dr. Gisela Scharbert, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04488198    
Other Study ID Numbers: 1773/2018
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Colitis, Ulcerative
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases