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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Complex Regional Pain Syndrome Type I

Intervention / Treatment
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* Diagnostic Test: questionnaires
* Diagnostic Test: holter electrocardiogram
* Diagnostic Test: blood pressure
* Other: relaxation sessions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complex Regional Pain Syndrome (CRPS)<br>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. | Diagnostic Test: questionnaires<br>* 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)<br>Diagnostic Test: holter electrocardiogram<br>* Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.<br>Diagnostic Test: blood pressure<br>* Blood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after relaxation sessions.<br>Other: relaxation sessions<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high frequency index | measured by holter electrocardiogram. | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | at 3 months | 
| life quality of children | by questionnaire KIDSCREEN 52 | at 3 months | 
| evaluation of pain | by questionnaire EVA | at 3 months | 
| evaluation of pain | by questionnaire DN4 | at 3 months | 
| evaluation of pain | by questionnaire DEGR | at 3 months | 
| intensity of pain | with Eland Color Scale | at 3 months | 
| location of pain | with Eland Color Scale | at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relaxation, Bergès relaxation, Pain, Children, Complex Regional Pain Syndrome