Pain Neuroscience Education in Healthy Children

Pain Clinical Trial

Official title:

Pain Neuroscience Education in Healthy Children: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164343
• Other study ID #: Eduvalid Study (Part 2)
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: September 22, 2018

Study information

• Verified date: July 2019
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 vigilance and awareness.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 22, 2018
• Est. primary completion date: September 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Healthy children

2. Informed consent

Exclusion Criteria:

1. Previous pain education

2. Chronic pain

3. Insufficient knowledge of the Dutch language

4. Mental retardation

5. Parent with chronic pain

Related Conditions & MeSH terms

• Child
• Pain

Intervention

Device:
• Pain Neuroscience Education for children
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.

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussels	Jette

Sponsors (2)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

References & Publications (19)

Boerner KE, Noel M, Birnie KA, Caes L, Petter M, Chambers CT. Impact of Threat Level, Task Instruction, and Individual Characteristics on Cold Pressor Pain and Fear among Children and Their Parents. Pain Pract. 2016 Jul;16(6):657-68. doi: 10.1111/papr.12306. Epub 2015 May 26. — View Citation

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. Review. — View Citation

Goodman JE, McGrath PJ. The epidemiology of pain in children and adolescents: a review. Pain. 1991 Sep;46(3):247-64. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Meeus M, Nijs J, Van Oosterwijck J, Van Alsenoy V, Truijen S. Pain physiology education improves pain beliefs in patients with chronic fatigue syndrome compared with pacing and self-management education: a double-blind randomized controlled trial. Arch Phys Med Rehabil. 2010 Aug;91(8):1153-9. doi: 10.1016/j.apmr.2010.04.020. — View Citation

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. Review. — View Citation

Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. — View Citation

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. — View Citation

Palermo TM, Chambers CT. Parent and family factors in pediatric chronic pain and disability: an integrative approach. Pain. 2005 Dec 15;119(1-3):1-4. Epub 2005 Nov 18. — View Citation

Pergolizzi J, Ahlbeck K, Aldington D, Alon E, Coluzzi F, Dahan A, Huygen F, Kocot-Kepska M, Mangas AC, Mavrocordatos P, Morlion B, Müller-Schwefe G, Nicolaou A, Pérez Hernández C, Sichère P, Schäfer 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. Review. — View Citation

Perquin CW, Hazebroek-Kampschreur AA, Hunfeld JA, Bohnen AM, van Suijlekom-Smit LW, Passchier J, van der Wouden JC. Pain in children and adolescents: a common experience. Pain. 2000 Jul;87(1):51-8. — View Citation

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). pii: E43. doi: 10.3390/children3040043. Review. — View Citation

Roth-Isigkeit A, Thyen U, Stöven H, Schwarzenberger J, Schmucker P. Pain among children and adolescents: restrictions in daily living and triggering factors. Pediatrics. 2005 Feb;115(2):e152-62. Erratum in: Pediatrics. 2005 Apr;115(4):1118. — View Citation

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. Review. — View Citation

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. — View Citation

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):1118-27. doi: 10.1016/j.pain.2014.02.021. Epub 2014 Mar 12. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline (before PNE) to immediately after PNE and 1 week following PNE
Primary	Neurophysiology of Pain Questionnaire (NPQ)	The parent's knowledge of pain will also be assessed by the Neurophysiology of Pain Questionnaire (NPQ).	Change from baseline (before PNE) to immediately after PNE and 1 week following PNE
Secondary	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.	Baseline (before PNE) and 1 week following PNE
Secondary	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).	Baseline (Before PNE) and 1 week following PNE
Secondary	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).	Baseline (before PNE) and 1 week following PNE