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

March 20, 2019 updated by: Centre Hospitalier Universitaire de Saint Etienne
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: at 3 months
measured by holter electrocardiogram.
at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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