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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03309774
Enrollment
4
Registered
2017-10-16
Start date
2017-11-09
Completion date
2018-05-25
Last updated
2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome Type I

Keywords

Children, Complex Regional Pain Syndrome, Relaxation, Bergès relaxation, Pain

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.

Interventions

DIAGNOSTIC_TESTquestionnaires

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)

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

DIAGNOSTIC_TESTblood pressure

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

OTHERrelaxation 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
high frequency indexat 3 monthsmeasured by holter electrocardiogram.

Secondary

MeasureTime frameDescription
blood pressureat 3 months
life quality of childrenat 3 monthsby questionnaire KIDSCREEN 52
evaluation of painat 3 monthsby questionnaire EVA
intensity of painat 3 monthswith Eland Color Scale
location of painat 3 monthswith Eland Color Scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026