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

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ClinicalTrials.gov Identifier: NCT02880332
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Roselien Pas, Vrije Universiteit Brussel

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).

Condition or disease Intervention/treatment Phase
Abdominal Pain Irritable Bowel Syndrome Other: Usual care Other: Pain Neuroscience education Other: Extra care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endogenous Pain Processing and Effectiveness of Pain Neuroscience Education in Children With Functional Abdominal Pain and Irritable Bowel Syndrome
Actual Study Start Date : February 9, 2017
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
Active Comparator: Usual care + Extra care
This group will receive usual care and one additional session; extra care.
Other: Usual care
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.

Other: Extra care
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.

Experimental: Usual care + PNE
Next to usual care, this group will also receive pain neuroscience education.
Other: Usual care
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.

Other: Pain Neuroscience education
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.
Other Name: PNE




Primary Outcome Measures :
  1. Parent's catastrophic thinking about their child's pain [ Time Frame: 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) ]
    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.


Secondary Outcome Measures :
  1. Pain intensity (child report) [ Time Frame: Baseline (at recruitment), before interventions, 1 week after both interventions and at follow-up (3 weeks following intervention) ]
    Pain intensity will be measured using the Faces Pain Scale - Revised (FPS-R)(Hicks et al. 2001)(Dutch version), which is a self-report measure of pain intensity developed for children. It contains 6 faces that are presented horizontally. Children will be asked to point to the face that best reflects the intensity of their current pain and their pain over the last week (average, highest and lowest).

  2. Pain-related fear (parent report) [ Time Frame: Baseline (at recruitment), before interventions, 1 week after both interventions and at follow-up (3 weeks following intervention) ]
    For parental report, the Parent Fear of Pain Questionnaire (PFOPQ)(Simons et al. 2015) will be used. The PFOPQ assesses a parent's fears and avoidance behaviours associated with their child's pain. For child report, the Kuttner Anxiety Scale will be used. This measure consists of faces for assessing pain-related fear even in young children. A Dutch translation will be used for both measures.

  3. Functional disability (parent proxy report) [ Time Frame: Baseline (at recruitment), before interventions, 1 week after both interventions and at follow-up (3 weeks following intervention) ]
    The Functional Disability Inventory (FDI)(Dutch version)(Crombez et al. 2003) is a parent-report inventory for children that measures perceived difficulty in physical and psychosocial functioning due to physical health. It consists of 15 items to be rated on a five-point scale (0-4) concerning perceptions of activity limitations during the past 2 weeks. Total scores range from 0 to 60. Higher scores indicate greater disability.

  4. Pain-related fear (child report) [ Time Frame: Baseline (at recruitment), before interventions, 1 week after both interventions and at follow-up (3 weeks following intervention) ]
    For child report, the Kuttner Anxiety Scale will be used. This measure consists of faces for assessing pain-related fear even in young children. A Dutch translation will be used for both measures.

  5. Hyperalgesia [ Time Frame: Baseline (at recruitment) and at follow-up (3 weeks following last intervention) ]
    Hyperalgesia will be assessed by evaluating pressure pain thresholds (PPT) at a symptomatic test site (rectus abdominus near the umbilical region) and two remote test sites (tibialis anterior and trapezius) with a hand-held pressure Algometer (Wagner Instruments, FPX 25).

  6. Endogenous pain inhibition [ Time Frame: Baseline (at recruitment) and at follow-up (3 weeks following last intervention) ]
    Within the CPM paradigm the perceived pain intensity to a test stimulus before and during/after the addition of a harmful conditioning stimulus will be measured. This study will use the Cold Pressure Task as 'conditioning stimulus' and mechanical stimulation to perform a 'test stimulus'.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT02880332


Locations
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Belgium
Antwerp University Hospital
Edegem, Antwerpen, Belgium, 2650
Sponsors and Collaborators
Vrije Universiteit Brussel
Universiteit Antwerpen
Investigators
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Principal Investigator: Roselien Pas, MSc Universiteit Antwerpen

Publications:
Merskey, H. & Bogduk, N., 1994. IASP Task Force on Taxonomy Part III: Pain Terms, A Current List with Definitions and Notes on Usage. IASP Task Force on Taxonomy, pp.209-214. Available at: http://www.iasp-pain.org/Content/NavigationMenu/GeneralResourceLinks/PainDefinitions/default.htm#Pain.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roselien Pas, Dra. Roselien Pas, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT02880332     History of Changes
Other Study ID Numbers: AbdominalPainStudy
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roselien Pas, Vrije Universiteit Brussel:
Chronic pain
Endogenous Pain Processing
Central sensitization
Pain neuroscience education

Additional relevant MeSH terms:
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Syndrome
Irritable Bowel Syndrome
Abdominal Pain
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive