Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance

Overview

Complex regional pain syndrome (CRPS) is a disease provoking chronic pain in the limbs, following a trauma. Patient care is complicated by the variable clinical picture and response to treatment. The stress level of the organization, for chronic pain impacts the regulation of the autonomic balance. The study of time and frequency domain analysis of Heart Rate Variability (HRV) allows non-invasive and reproducible assessment of the autonomic balance.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 25, 2018

Detailed Description

The hypothesis in this study is that the sympathovagal balance could be altered in children with CRPS. But the impact of relaxation on pain and balance has been proven. This study aims to assess the impact of the assumption by the relaxation therapy in children suffering from CRPS, on sympathovagal balance.

It is an experimental prospective single-center study to highlight after a standardized relaxation program, changes in the time and frequency indices variability in heart rate, parameters of pain and quality of life with the CRPS children 6 to 16 years.

Interventions

  • Diagnostic Test: questionnaires
    • Children with Complex Regional Pain Syndrome (CRPS) will be filled questionnaires before and after relaxation sessions. These questionnaire evaluate the quality of life and pain of child There will be: Questionnaire KIDSCREEN 52 Visual Analogue Scale (EVA) Neuropathic Pain 4 (DN4) Pain of the child Gustave Roussy (DEGR)
  • Diagnostic Test: holter electrocardiogram
    • Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.
  • Diagnostic Test: blood pressure
    • Blood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after relaxation sessions.
  • Other: relaxation sessions
    • Children with Complex Regional Pain Syndrome (CRPS) will be performed 20 relaxation sessions and 2 per week. During relaxation sessions children will be recorded by voice recorder. Children should describe his feelings at the preceding session. After every relaxation sessions children evaluate pain according to Eland Color Scale.

Arms, Groups and Cohorts

  • Experimental: Complex Regional Pain Syndrome (CRPS)
    • Children 6 to 12 years old child with Complex Regional Pain Syndrome (CRPS) type 1 will be included. They will have questionnaires, holter electrocardiogram, blood pressure and relaxation sessions.

Clinical Trial Outcome Measures

Primary Measures

  • high frequency index
    • Time Frame: at 3 months
    • measured by holter electrocardiogram.

Secondary Measures

  • blood pressure
    • Time Frame: at 3 months
  • life quality of children
    • Time Frame: at 3 months
    • by questionnaire KIDSCREEN 52
  • evaluation of pain
    • Time Frame: at 3 months
    • by questionnaire EVA
  • evaluation of pain
    • Time Frame: at 3 months
    • by questionnaire DN4
  • evaluation of pain
    • Time Frame: at 3 months
    • by questionnaire DEGR
  • intensity of pain
    • Time Frame: at 3 months
    • with Eland Color Scale
  • location of pain
    • Time Frame: at 3 months
    • with Eland Color Scale

Participating in This Clinical Trial

Inclusion Criteria

  • Parents affiliates or entitled to a social security scheme
  • Children from 6 to 16 years with Complex Regional Pain Syndrome (CRPS) type 1
  • Diagnosis according to the Budapest criteria.

Exclusion Criteria

  • Child with pathologies reaching the central nervous system or the brain stem.
  • Children with a severe pathology of cardio-respiratory or heart being referred to treatment.
  • Children requiring emergency surgery or trauma or septic or inflammatory context.
  • Children with some psychiatric diseases
  • Children who no understand french enough

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vincent Gautheron, MD PhD, Principal Investigator, CHU Saint-Etienne

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