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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Complex Regional Pain Syndrome Type I

Treatments: Other: relaxation sessions; Diagnostic Test: questionnaires; Diagnostic Test: holter electrocardiogram; Diagnostic Test: blood pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03309774

2017-A02092-51 (Other Identifier)

1708124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Complex Regional Pain Syndrome (CRPS)

Experimental group

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.

Treatment:

Diagnostic Test: holter electrocardiogram

Diagnostic Test: questionnaires

Diagnostic Test: blood pressure

Other: relaxation sessions