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

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 Overview

• Status: Terminated
• Conditions: Complex Regional Pain Syndrome Type I
• Intervention / Treatment: Diagnostic test: questionnaires; Diagnostic test: holter electrocardiogram; Diagnostic test: blood pressure; Other: relaxation sessions

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • CHU de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2017
• Primary Completion (ACTUAL): May 25, 2018
• Study Completion (ACTUAL): May 25, 2018

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (ACTUAL): October 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Children; Relaxation; Complex Regional Pain Syndrome; Bergès relaxation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: 1708124; 2017-A02092-51 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No