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

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 |

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

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
Belgium | |
Antwerp University Hospital | |
Edegem, Antwerpen, Belgium, 2650 |
Principal Investigator: | Roselien Pas, MSc | Universiteit Antwerpen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Roselien Pas, Dra. Roselien Pas, Vrije Universiteit Brussel |
ClinicalTrials.gov Identifier: | NCT02880332 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic pain Endogenous Pain Processing Central sensitization Pain neuroscience education |
Irritable Bowel Syndrome Syndrome Abdominal Pain Disease Pathologic Processes Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Pain Neurologic Manifestations Signs and Symptoms, Digestive |