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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
high frequency index
Time Frame: at 3 months
measured by holter electrocardiogram.
at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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