Complex Regional Pain Syndrome Type I Clinical Trial
Official title:
Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
Verified date | March 2019 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | May 25, 2018 |
Est. primary completion date | May 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Saint Etienne | Saint Etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | high frequency index | measured by holter electrocardiogram. | at 3 months | |
Secondary | blood pressure | at 3 months | ||
Secondary | life quality of children | by questionnaire KIDSCREEN 52 | at 3 months | |
Secondary | evaluation of pain | by questionnaire EVA | at 3 months | |
Secondary | evaluation of pain | by questionnaire DN4 | at 3 months | |
Secondary | evaluation of pain | by questionnaire DEGR | at 3 months | |
Secondary | intensity of pain | with Eland Color Scale | at 3 months | |
Secondary | location of pain | with Eland Color Scale | at 3 months |
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