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

Not Applicable

Terminated

• Conditions: Complex Regional Pain Syndrome Type I

• Registration Number: NCT03309774
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-16
• Study Start: 2017-11-09
• Primary Completion: 2018-05-25
• Study Completion: 2018-05-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
high frequency index	at 3 months	measured by holter electrocardiogram.

Secondary Outcome Measures

Name	Time	Method
intensity of pain	at 3 months	with Eland Color Scale
location of pain	at 3 months	with Eland Color Scale
life quality of children	at 3 months	by questionnaire KIDSCREEN 52
blood pressure	at 3 months
evaluation of pain	at 3 months	by questionnaire DEGR

Trial Locations

Locations (1)

CHU de Saint Etienne; 🇫🇷 Saint Etienne, France