NCT03309774

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

November 9, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2018

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

October 5, 2017

Last Update Submit

March 20, 2019

Conditions

Complex Regional Pain Syndrome Type I

Keywords

ChildrenComplex Regional Pain SyndromeRelaxationBergès relaxationPain

Outcome Measures

Primary Outcomes (1)

  • high frequency index

    measured by holter electrocardiogram.

    at 3 months

Secondary Outcomes (7)

  • blood pressure

    at 3 months

  • life quality of children

    at 3 months

  • evaluation of pain

    at 3 months

  • evaluation of pain

    at 3 months

  • evaluation of pain

    at 3 months

  • +2 more secondary outcomes

Study Arms (1)

Complex Regional Pain Syndrome (CRPS)

EXPERIMENTAL

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: questionnairesDiagnostic Test: holter electrocardiogramDiagnostic Test: blood pressureOther: relaxation sessions

Interventions

questionnairesDIAGNOSTIC_TEST

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)

Complex Regional Pain Syndrome (CRPS)
holter electrocardiogramDIAGNOSTIC_TEST

Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.

Complex Regional Pain Syndrome (CRPS)
blood pressureDIAGNOSTIC_TEST

Blood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after relaxation sessions.

Complex Regional Pain Syndrome (CRPS)
relaxation sessionsOTHER

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.

Complex Regional Pain Syndrome (CRPS)

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Complex Regional Pain SyndromesPain

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Vincent Gautheron, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 16, 2017

Study Start

November 9, 2017

Primary Completion

May 25, 2018

Study Completion

May 25, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)