NCT03309774

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complex Regional Pain Syndrome Type I

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-09
• Primary completion: 2018-05-25
• Completion: 2018-05-25
• First posted: 2017-10-16
• Last updated: 2019-03-21

Locations

1 site across 1 country: France