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. 2021 Nov 29;2021(11):CD013531. doi: 10.1002/14651858.CD013531.pub2

NCT03348852.

Study name Association between functional changes in the brain and the perception of pain in patients with inflammatory bowel diseases (IBD) ‐ measured with functional magnetic resonance imaging
Methods RCT
Participants 84 adults 18 to 80 years old
Interventions IG: transcranial direct current stimulation
CG: sham transcranial direct current stimulation
Outcomes Primary outcome measures:
  1. Functional and/or structural changes in the brain measured with cerebral MRI [ Time Frame: 2 week ] Participants will be followed for 2 weeks.

  2. Changes in pain measured with VAS [ Time Frame: 2 weeks ] Participants will be followed for 2 weeks.

  3. Changes in perception of pain measured with an algometer (pain pressure threshold) [ Time Frame: 2 weeks ] Participants will be followed for 2 weeks.


Secondary outcome measures:
  1. Changes in questionnaire "quality of life" [ Time Frame: 2 weeks ] questionnaire

  2. Changes in functional symptoms [ Time Frame: 2 weeks ] Questionnaire: IBS‐SSS

  3. Changes in activity indices [ Time Frame: 2 weeks ] HBI or SCCAI

  4. Changes in pain catastrophising scale [ Time Frame: 2 weeks ]

  5. Changes in inflammation biomarker (blood ‐ CRP) [ Time Frame: 2 weeks ]

  6. Changes in inflammation biomarker (stool ‐ calprotectin) [ Time Frame: 2 weeks ]

Starting date 24 January 2017
Contact information magdalena.pruess@charite.de
Notes Sponsor: Charite University, Berlin, Germany