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Abdominal PainNCT02880332

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

A study testing Pain Neuroscience education and Extra care in people with Abdominal Pain and Irritable Bowel Syndrome, run by Vrije Universiteit Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Abdominal Pain, Irritable Bowel Syndrome
What is being tested?
Pain Neuroscience education and Extra care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteBelgium
Study dates
9 Feb 2017to 4 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Antwerp University Hospital

    Edegem, Antwerpen, 2650

Other trials in Belgium

About this study

Official title: Endogenous Pain Processing and Effectiveness of Pain Neuroscience Education in Children With Functional Abdominal Pain and Irritable Bowel Syndrome

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).

Read the detailed description

Abdominal pain-related functional gastrointestinal disorders (AP-FGIDs) are common in children, showing a prevalence of 13.5% in Western populations and developing countries. Gastrointestinal disorders are categorised within the Rome criteria III, with irritable bowel syndrome (IBS) (65%) and functional abdominal pain (FAP) (35%) as most commonly occurring subtypes, followed by FAP syndrome, functional dyspepsia and abdominal migraine. These numbers call for action, knowing that persistent pain periods associated with AP-FGIDs significantly interferes with a child's daily functioning. Children suffering from AP-FGIDs participate less during recreational activities, show difficulties in maintaining social contacts, are more absent at school and express academic impairments. Additionally, they report decreased health related quality of life and need more health care utilization.

To date, the pathogenesis underlying AP-FGIDs in children remains unclear. Previous studies suggested abnormal brain-gut interaction, altered gut motility, visceral hypersensitivity, psychosocial disturbance and immune activation as possible explanations for the symptoms. In accordance to research in adults with FGIDs evidence is even growing for the contribution of central sensitization (CS) in the development or persistence of AP-FGIDs in children. CS is defined as "an amplification of neural signalling within the central nervous system that elicits pain hypersensitivity" or "increased responsiveness of nociceptive neurons in the central nervous system to their normal or subthreshold afferent input". This process encompasses malfunctioning of descending inhibitory nociceptive pathways which result in dysfunctional endogenous analgesic control and increased activity of descending nociceptive facilitation and overactivity of the pain neuromatrix in the brain. A systematic review addressing the contribution of CS in pediatric chronic pain conditions concluded that manifestations such as somatic hyperalgesia and altered central pain processing in children with recurrent abdominal pain disorders (RAP) and deficient descending inhibitory nociceptive processing in girls with irritable bowel syndrome (IBS) are indicative of CS in some subtypes of AP-FGIDs (review in progress). However, given the heterogeneous study populations, different protocols and methods used to objectify the presence of CS in this review, no clear statement could be made. In addition, no study examining descending inhibitory nociceptive processing in children with FAP was found.

Descending inhibitory nociceptive processing might be dysfunctional in children with FAP and IBS. Anyhow, research demonstrated that this manifestation of CS can be further influenced by the child's characteristics. Behavioural responses, emotional and cognitive aspects are involved in the facilitation of sensitization through an increased cerebral activation of limbic structures, the insula and large areas of the frontal, temporal and parietal cortices, resulting in a diminished inhibition of the descending pathways.

Parental behaviours may also play an important role in the child's adjustment to pain. Parents are considered essential participants in the management of their child's pain, as parental attitudes, responses, and beliefs can influence the child's pain and adherence to treatment. Indeed, both parental solicitous behaviours (e.g., according special privileges to the child) and parental discouraging behaviours (e.g., criticizing the child) have been found to be associated with increased functional disability. Further, evidence suggests that children's own pain beliefs and pain coping skills may be modelled after their parents' (maladaptive) pain beliefs and pain coping skills. Additionally, increased levels of parent emotional distress have been linked to higher levels of child functional disability and self-reported pain. This underscores the importance of including parents in the assessment and treatment of pediatric chronic pain for optimal outcomes.

Negative cognitions of both the parents and the child can develop when they do not understand the origin of the FAP or IBS. Based on the premise that a better understanding of the nature of the illness results in improved patient outcomes, both child and parents should be addressed by education. Given the possible contribution of CS in children with FAP or IBS, education should 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. This main content can be given by pain neuroscience education (PNE). PNE has been studied in various adult chronic pain populations and has shown to be effective in changing pain beliefs and improving health status as well as pain coping strategies.

In contrast to a traditional model of tissue injury or nociception and pain, PNE aims to describe how the nervous system interprets information from tissues through peripheral nerve sensitization, central sensitization, synaptic activity and brain processing. It also explains how neural activation, as either upregulation or downregulation, has the ability to modulate the pain experience in response to (or in absence of) nociceptive input. Patients are thus educated that the nervous system's processing of their injury, in conjunction with various psychosocial aspects, determines their pain experience and that pain is not always a true representation of the status of the tissues. Up to recently, no studies have examined the benefits of PNE in the context of pediatric chronic pain. Drawing upon available evidence in adult samples, it is expected that PNE provided to children will lead to beneficial child pain-related outcomes. Involving parents in PNE sessions will facilitate increased parental understanding of biopsychosocial factors that influence their child's pain, as well as learn how they can support their child to manage symptoms.

Concrete, the present study will examine (1) the function of descending inhibitory nociceptive processing in children with FAP or IBS compared to healthy children (Part 1) and whether (2) reconceptualization of pain, by PNE, is able to influence pain catastrophizing, pain-related fear, pain intensity (including symptoms and indices of central sensitization) and pain-related functional disability (Part 2).

Being tested
Usual care, Pain Neuroscience education, Extra care
Keywords
Chronic pain, Endogenous Pain Processing, Central sensitization, Pain neuroscience education
Medical subject headings
Abdominal Pain, Irritable Bowel Syndrome, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual careOther

    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.

  • Pain Neuroscience educationOther

    Also called PNE

    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.

  • Extra careOther

    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.

Study groups in NCT02880332
Study groupRoleWhat they receive
Usual care + Extra careActive comparatorThis group will receive usual care and one additional session; extra care.
Receives: Other: Usual care; Other: Extra care
Usual care + PNEExperimentalNext to usual care, this group will also receive pain neuroscience education.
Receives: Other: Usual care; Other: Pain Neuroscience education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Pain intensity (child report)

    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).

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

  2. Pain-related fear (parent report)

    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.

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

  3. Functional disability (parent proxy report)

    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.

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

  4. Pain-related fear (child report)

    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.

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

  5. Hyperalgesia

    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).

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

  6. Endogenous pain inhibition

    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'.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2016 (estimated)
  2. Study start9 Feb 2017
  3. Primary completion4 Oct 2018
  4. Study completion4 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02880332
Sponsor's protocol ID
AbdominalPainStudy
Status last verified
Oct 2018
First submitted
17 Aug 2016
Last updated
5 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alfven G. The pressure pain threshold (PPT) of certain muscles in children suffering from recurrent abdominal pain of non-organic origin. An algometric study. Acta Paediatr. 1993 May;82(5):481-3. doi: 10.1111/j.1651-2227.1993.tb12727.x.

    PubMed 8518526
  • Brown LK, Beattie RM, Tighe MP. Practical management of functional abdominal pain in children. Arch Dis Child. 2016 Jul;101(7):677-83. doi: 10.1136/archdischild-2014-306426. Epub 2015 Dec 23.

    PubMed 26699533
  • Caes L, Vervoort T, Eccleston C, Goubert L. Parents who catastrophize about their child's pain prioritize attempts to control pain. Pain. 2012 Aug;153(8):1695-1701. doi: 10.1016/j.pain.2012.04.028. Epub 2012 May 31.

    PubMed 22657401
  • Crombez G, Bijttebier P, Eccleston C, Mascagni T, Mertens G, Goubert L, Verstraeten K. The child version of the pain catastrophizing scale (PCS-C): a preliminary validation. Pain. 2003 Aug;104(3):639-646. doi: 10.1016/S0304-3959(03)00121-0.

    PubMed 12927636
  • Duarte MA, Goulart EM, Penna FJ. Pressure pain threshold in children with recurrent abdominal pain. J Pediatr Gastroenterol Nutr. 2000 Sep;31(3):280-5. doi: 10.1097/00005176-200009000-00015.

    PubMed 10997373
  • Goubert L, Eccleston C, Vervoort T, Jordan A, Crombez G. Parental catastrophizing about their child's pain. The parent version of the Pain Catastrophizing Scale (PCS-P): a preliminary validation. Pain. 2006 Aug;123(3):254-263. doi: 10.1016/j.pain.2006.02.035. Epub 2006 Apr 27.

    PubMed 16644128
  • Hermann C, Zohsel K, Hohmeister J, Flor H. Cortical correlates of an attentional bias to painful and innocuous somatic stimuli in children with recurrent abdominal pain. Pain. 2008 Jun;136(3):397-406. doi: 10.1016/j.pain.2008.01.007. Epub 2008 Feb 13.

    PubMed 18276076
  • Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

    PubMed 11427329
  • Jackson T, Pope L, Nagasaka T, Fritch A, Iezzi T, Chen H. The impact of threatening information about pain on coping and pain tolerance. Br J Health Psychol. 2005 Sep;10(Pt 3):441-51. doi: 10.1348/135910705X27587.

    PubMed 16238858
  • Korterink JJ, Diederen K, Benninga MA, Tabbers MM. Epidemiology of pediatric functional abdominal pain disorders: a meta-analysis. PLoS One. 2015 May 20;10(5):e0126982. doi: 10.1371/journal.pone.0126982. eCollection 2015.

    PubMed 25992621
  • Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.

    PubMed 22133255
  • McMurtry MC. How do I love thee? Let me count the ways of responding and regulating. Pain. 2014 Aug;155(8):1421-1422. doi: 10.1016/j.pain.2014.05.011. Epub 2014 May 15. No abstract available.

    PubMed 24837845
  • Meeus M, Nijs J. Central sensitization: a biopsychosocial explanation for chronic widespread pain in patients with fibromyalgia and chronic fatigue syndrome. Clin Rheumatol. 2007 Apr;26(4):465-73. doi: 10.1007/s10067-006-0433-9. Epub 2006 Nov 18.

    PubMed 17115100
  • 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.

  • Millan MJ. Descending control of pain. Prog Neurobiol. 2002 Apr;66(6):355-474. doi: 10.1016/s0301-0082(02)00009-6.

    PubMed 12034378

Questions about this trial

What is this clinical trial studying?

A study testing Pain Neuroscience education and Extra care in people with Abdominal Pain and Irritable Bowel Syndrome, run by Vrije Universiteit Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02880332, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.

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