Pain Processing and Pain Neuroscience Education in Children With Chronic Abdominal Pain

NCT02880332 | Completed

• 1 other identifier: AbdominalPainStudy
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The primary scientific objective of the study entails examining whether altered endogenous pain inhibition is present in children with functional abdominal pain (FAP) and irritable bowel syndrome (IBS) compared with healthy controls (Part 1). A secondary objective implies examining whether pediatric pain neuroscience education (PNE) is able to improve pain catastrophizing, pain-related fear, pain intensity (including symptoms and indices of central sensitization) and pain-related functional disability in children with FAP or IBS (Part 2).

Conditions

Abdominal Pain; Irritable Bowel Syndrome

Keywords

Chronic pain; Endogenous Pain Processing; Central sensitization; Pain neuroscience education

Outcome Measures

Primary Outcomes (1)

• Parent's catastrophic thinking about their child's pain

  This outcome will be assessed with the Dutch version of the Pain Catastrophizing Scale for Parents (PCS-P) (Goubert et al. 2006). The PCS-P consists of 13 items describing different thoughts and feelings that parents may experience in relation to their child's pain.

  Change baseline (at recruitment) to post- intervention (1week following intervention), baseline to follow-up (3 weeks following intervention) and post-intervention to follow up (3 weeks following intervention)

Secondary Outcomes (6)

• Pain intensity (child report)

  Baseline (at recruitment), before interventions, 1 week after both interventions and at follow-up (3 weeks following intervention)

• Pain-related fear (parent report)

  Baseline (at recruitment), before interventions, 1 week after both interventions and at follow-up (3 weeks following intervention)

• Functional disability (parent proxy report)

  Baseline (at recruitment), before interventions, 1 week after both interventions and at follow-up (3 weeks following intervention)

• Pain-related fear (child report)

  Baseline (at recruitment), before interventions, 1 week after both interventions and at follow-up (3 weeks following intervention)

• Hyperalgesia

  Baseline (at recruitment) and at follow-up (3 weeks following last intervention)

Study Arms (2)

Usual care + Extra care

ACTIVE COMPARATOR

This group will receive usual care and one additional session; extra care.

Other: Usual care; Other: Extra care

Usual care + PNE

EXPERIMENTAL

Next to usual care, this group will also receive pain neuroscience education.

Other: Usual care; Other: Pain Neuroscience education

Interventions

Usual care OTHER

During usual care therapy, children and their parents will receive a +/- 1 h session containing bio-medical directed education and information about the gastro-intestinal system and its function. This knowledge will be brought to bear with a hypnotic journey through their body, guided by a nurse with specific expertise in pediatric abdominal pain. Furthermore, the influence of stress on the gastro-intestinal system will be explained, combined with exercises to practise abdominal respiration.

Usual care + Extra care; Usual care + PNE

Pain Neuroscience education OTHER

This therapy will consist out of a +/- 1 h one-on-one educational session about neurophysiology of pain, adjusted to the child's comprehension status. The content of the education sessions and pictures will be based on the book "Explain Pain" by Butler and Moseley and will include explanation and reassurance about the cause of pain, a brief summary of relevant pain mechanisms and the integral role of psychosocial and physical factors in precipitating and maintaining pain. Metaphors, leaflets, books and audio-visual media will be used in a supportive function to consolidate verbally transmitted information. Parents will participate in the PNE session as well.

Also known as: PNE

Usual care + PNE

Extra care OTHER

During this therapy session, all the patient's/ parents questions that arose from the previous session (Usual care) will be answered. Afterwards, the educated content from this previous session will be revised. Nothing new will be taught. At the end of the session, the participant will be asked to demonstrate the previously learned exercises on abdominal respiration. If the exercises are not well performed, the therapist will correct them.

Usual care + Extra care

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent
• \> 3 months pain
• diagnosis functional abdominal pain or irritable bowel syndrome

You may not qualify if:

• Concomitant organic gastrointestinal disease or chronic disease
• Ongoing specific treatment by another health care specialist (physician or psychotherapist) for abdominal pain symptoms
• Previous pain education or relaxation therapy
• Mental retardation
• Insufficient knowledge of the Dutch language
• Preterm birth
• Menstruation

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

Location

Related Publications (37)

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MeSH Terms

Conditions

Abdominal Pain; Irritable Bowel Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Roselien Pas, MSc

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra. Roselien Pas

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 26, 2016
• Study Start: February 9, 2017
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)