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

Primary Purpose

Complex Regional Pain Syndrome Type I

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaires
holter electrocardiogram
blood pressure
relaxation sessions
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Complex Regional Pain Syndrome Type I focused on measuring Children, Complex Regional Pain Syndrome, Relaxation, Bergès relaxation, Pain

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • CHU de Saint Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Complex Regional Pain Syndrome (CRPS)

Arm Description

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.

Outcomes

Primary Outcome Measures

high frequency index
measured by holter electrocardiogram.

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2017
Last Updated
March 20, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03309774
Brief Title
Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
Official Title
Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
failing of recruitment
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
May 25, 2018 (Actual)
Study Completion Date
May 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome Type I
Keywords
Children, Complex Regional Pain Syndrome, Relaxation, Bergès relaxation, Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complex Regional Pain Syndrome (CRPS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
questionnaires
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
holter electrocardiogram
Intervention Description
Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.
Intervention Type
Diagnostic Test
Intervention Name(s)
blood pressure
Intervention Description
Blood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after relaxation sessions.
Intervention Type
Other
Intervention Name(s)
relaxation sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
high frequency index
Description
measured by holter electrocardiogram.
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
at 3 months
Title
life quality of children
Description
by questionnaire KIDSCREEN 52
Time Frame
at 3 months
Title
evaluation of pain
Description
by questionnaire EVA
Time Frame
at 3 months
Title
evaluation of pain
Description
by questionnaire DN4
Time Frame
at 3 months
Title
evaluation of pain
Description
by questionnaire DEGR
Time Frame
at 3 months
Title
intensity of pain
Description
with Eland Color Scale
Time Frame
at 3 months
Title
location of pain
Description
with Eland Color Scale
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Gautheron, MD PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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