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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Terminated

CT.gov ID

NCT03309774

Collaborator

(none)

Enrollment

Location

Arm

6.5

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndrome Type I	Diagnostic Test: questionnaires Diagnostic Test: holter electrocardiogram Diagnostic Test: blood pressure Other: relaxation sessions	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Nov 9, 2017

Actual Primary Completion Date :

May 25, 2018

Actual Study Completion Date :

May 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

high frequency index [at 3 months]
measured by holter electrocardiogram.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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