AzTrials
AzTrials

ChildNCT03164343

Pain Neuroscience Education in Healthy Children

A study testing Pain Neuroscience Education for children in people with Child and Pain, 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 objective of this study is to examine whether Pain Neuroscience Education for children is able to increase a child's knowledge on the neurophysiology of pain. In addition, this study investigates the influence of PNE on several pain related outcomes; pain-related fear, pain catastrophizing and pain… Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Child, Pain
What is being tested?
Pain Neuroscience Education for children
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteBelgium
Study dates
8 Aug 2017to 22 Sep 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 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy children
  • Informed consent

Who cannot join

  • Previous pain education
  • Chronic pain
  • Insufficient knowledge of the Dutch language
  • Mental retardation
  • Parent with chronic pain

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Vrije Universiteit Brussel

    Brussels, Jette, 1090

Other trials in Belgium

About this study

Official title: Pain Neuroscience Education in Healthy Children: A Pilot Study

The primary objective of this study is to examine whether Pain Neuroscience Education for children is able to increase a child's knowledge on the neurophysiology of pain.

In addition, this study investigates the influence of PNE on several pain related outcomes; pain-related fear, pain catastrophizing and pain vigilance and awareness.

Read the detailed description

Pain is a common and daily experience among children that is usually short-term, causing little to moderate discomfort. Yet, a substantial number of children experience chronic pain. Persistent pain periods mainly affect the children's school attendance and participation in recreational activities, possibly leading to academic impairments and social exclusion. Even worse is the children's greater predisposition to develop chronic pain into adulthood. Considering these disadvantages, children suffering from chronic pain should be treated as fast as possible and in the most optimal way. The existing literature on management in children with chronic pain encourages a multidisciplinary approach involving physical therapy and psychological interventions (i.e. cognitive behavioural therapy).

Recently, the application of Pain Neuroscience Education (PNE) as an intervention on its own, as well as in combination with another form of therapy (such as physiotherapy or cognitive- behavioural therapy) is receiving growing interest in the pediatric field of chronic pain. PNE aims to make people understand how their pain is produced and enables them to integrate this understanding into their everyday lives and subsequent treatment components. This innovative education style has shown to be effective in various adult chronic pain populations, by improving the patients' pain coping strategies and health status, and changing their pain beliefs. Although, no study examined the effectiveness of PNE in the context of chronic pediatric pain.

The hypothetical efficacy of pediatric PNE is based on previous findings in adult research that a better understanding of the nature of the illness results in improved patient outcomes. When children do not understand the origin of their pain, they might develop irrational beliefs and fears (including catastrophizing) about their pain, sustaining the vicious circle of chronic pain. Indeed, the information and context in which children perceive their pain, has been shown to modulate pain expectations and emotional response to pain. Since research findings showed that even parental beliefs about the aetiology of the child's pain influences the child's pain outcomes, the role of parents as 'pain modulators' might not be underestimated. Therefore, parents should be involved during PNE.

Concrete, the present study will examine whether reconceptualization of pain, by PNE is able to influence both child and parent knowledge of pain, as well as some other pain-related outcomes.

Conditions
Child, Pain
Being tested
Pain Neuroscience Education for children
Keywords
Pain Neuroscience Education
Medical subject headings
Pain

What participants receive

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

  • Pain Neuroscience Education for childrenDevice

    Children and their parent will receive a +/- 1h one-on-one educational session about the neurophysiology of pain, adjusted to the child's comprehension status. Parents will be present in the PNE session too. The PNE program for children contains two sections: (1) The healthy pain system and its function, divided in subsections each consisting of a specific neurophysiological pain concept (i.e. central nervous system anatomy, nociception and nociceptive pathways, up- and down-regulation of the nervous system) and (2) adaptations of the pain system following persistent pain. To ensure interaction between therapist and child, an interactive board game was developed and used throughout the full educational session.

Study groups in NCT03164343
Study groupRoleWhat they receive
Pain Neuroscience Education for childrenExperimentalAll participants within this study will receive Pain Neuroscience Education
Receives: Device: Pain Neuroscience Education for children

What is being measured

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

  1. Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ)

    The neurophysiology of pain knowledge of the child and parent will be assessed by using a questionnaire. The Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) will be used to determine the current knowledge of pain and to evaluate the effect of PNE.

    Measured: Change from baseline (before PNE) to immediately after PNE and 1 week following PNE

  2. Neurophysiology of Pain Questionnaire (NPQ)

    The parent's knowledge of pain will also be assessed by the Neurophysiology of Pain Questionnaire (NPQ).

    Measured: Change from baseline (before PNE) to immediately after PNE and 1 week following PNE

Secondary outcomes (3)

  1. Pain-related fear using the Fear of Pain Questionnaire - Parent version (FOPQ-P)

    For parental report, the Fear of Pain Questionnaire - Parent version (FOPQ-P) will be used to assess their own fear and avoidance behavior associated with their child's pain.

    Measured: Baseline (before PNE) and 1 week following PNE

  2. Catastrophic thinking about pain using the Dutch version of the Pain Catastrophizing Scale (PCS)

    Catastrophic thinking about pain will be measured using the Dutch version of the Pain Catastrophizing Scale (PCS).

    Parent's catastrophic thinking about their child's pain will be measured using the Dutch version of the Pain Catastrophizing Scale for Parents (PCS-P).

    Measured: Baseline (Before PNE) and 1 week following PNE

  3. Pain Vigilance and Awareness assessed by the Pain Vigilance and Awareness Questionnaire (PVAQ)

    Pain vigilance and awareness of the parent will be assessed by the Pain Vigilance and Awareness Questionnaire (PVAQ).

    Measured: Baseline (before PNE) and 1 week following PNE

Timeline

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

  1. First posted23 May 2017
  2. Study start8 Aug 2017
  3. Primary completion22 Sep 2018
  4. Study completion22 Sep 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03164343
Sponsor's protocol ID
Eduvalid Study (Part 2)
Status last verified
Jul 2019
First submitted
17 May 2017
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared with other researchers

Publications

  • Perquin CW, Hazebroek-Kampschreur AAJM, Hunfeld JAM, Bohnen AM, van Suijlekom-Smit LWA, Passchier J, van der Wouden JC. Pain in children and adolescents: a common experience. Pain. 2000 Jul;87(1):51-58. doi: 10.1016/S0304-3959(00)00269-4.

    PubMed 10863045

  • Pergolizzi J, Ahlbeck K, Aldington D, Alon E, Coluzzi F, Dahan A, Huygen F, Kocot-Kepska M, Mangas AC, Mavrocordatos P, Morlion B, Muller-Schwefe G, Nicolaou A, Perez Hernandez C, Sichere P, Schafer M, Varrassi G. The development of chronic pain: physiological CHANGE necessitates a multidisciplinary approach to treatment. Curr Med Res Opin. 2013 Sep;29(9):1127-35. doi: 10.1185/03007995.2013.810615. Epub 2013 Jul 3.

    PubMed 23786498

  • Goodman JE, McGrath PJ. The epidemiology of pain in children and adolescents: a review. Pain. 1991 Sep;46(3):247-264. doi: 10.1016/0304-3959(91)90108-A. No abstract available.

    PubMed 1758709

  • Simons LE, Basch MC. State of the art in biobehavioral approaches to the management of chronic pain in childhood. Pain Manag. 2016;6(1):49-61. doi: 10.2217/pmt.15.59. Epub 2015 Dec 17.

    PubMed 26678858

  • 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

  • Roth-Isigkeit A, Thyen U, Stoven H, Schwarzenberger J, Schmucker P. Pain among children and adolescents: restrictions in daily living and triggering factors. Pediatrics. 2005 Feb;115(2):e152-62. doi: 10.1542/peds.2004-0682.

    PubMed 15687423

  • Vervoort T, Logan DE, Goubert L, De Clercq B, Hublet A. Severity of pediatric pain in relation to school-related functioning and teacher support: an epidemiological study among school-aged children and adolescents. Pain. 2014 Jun;155(6):1118-1127. doi: 10.1016/j.pain.2014.02.021. Epub 2014 Mar 12.

    PubMed 24631587

  • Landry BW, Fischer PR, Driscoll SW, Koch KM, Harbeck-Weber C, Mack KJ, Wilder RT, Bauer BA, Brandenburg JE. Managing Chronic Pain in Children and Adolescents: A Clinical Review. PM R. 2015 Nov;7(11 Suppl):S295-S315. doi: 10.1016/j.pmrj.2015.09.006.

    PubMed 26568508

  • Goddard JM. Chronic pain in children and young people. Curr Opin Support Palliat Care. 2011 Jun;5(2):158-63. doi: 10.1097/SPC.0b013e328345832d.

    PubMed 21415756

  • Robins H, Perron V, Heathcote LC, Simons LE. Pain Neuroscience Education: State of the Art and Application in Pediatrics. Children (Basel). 2016 Dec 21;3(4):43. doi: 10.3390/children3040043.

    PubMed 28009822

  • Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.

    PubMed 26051220

  • 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

  • Van Oosterwijck J, Meeus M, Paul L, De Schryver M, Pascal A, Lambrecht L, Nijs J. Pain physiology education improves health status and endogenous pain inhibition in fibromyalgia: a double-blind randomized controlled trial. Clin J Pain. 2013 Oct;29(10):873-82. doi: 10.1097/AJP.0b013e31827c7a7d.

    PubMed 23370076

  • Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31.

    PubMed 21632273

  • Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.

    PubMed 12443524

Questions about this trial

What is this clinical trial studying?

A study testing Pain Neuroscience Education for children in people with Child and Pain, 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 2 inclusion and 5 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 Jul 2019. 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?

Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) (time frame: Change from baseline (before PNE) to immediately after PNE and 1 week following PNE). The study lists 2 primary outcomes in all. 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 NCT03164343, which also lists 19 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 Jul 2019.

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