Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02092-51 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
failing of recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complex Regional Pain Syndrome (CRPS) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires | Diagnostic Test | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| high frequency index | measured by holter electrocardiogram. | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | at 3 months | |
| life quality of children | by questionnaire KIDSCREEN 52 | at 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vincent Gautheron, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint Etienne | Saint-Etienne | 42055 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| holter electrocardiogram | Diagnostic Test | Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions. |
|
| blood pressure | Diagnostic Test | Blood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after relaxation sessions. |
|
| relaxation sessions | Other | 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. |
|
| evaluation of pain |
by questionnaire EVA |
| at 3 months |
| evaluation of pain | by questionnaire DN4 | at 3 months |
| evaluation of pain | by questionnaire DEGR | at 3 months |
| intensity of pain | with Eland Color Scale | at 3 months |
| location of pain | with Eland Color Scale | at 3 months |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |