Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
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|ClinicalTrials.gov Identifier: NCT03309774|
Recruitment Status : Terminated (failing of recruitment)
First Posted : October 16, 2017
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Complex Regional Pain Syndrome Type I||Diagnostic Test: questionnaires Diagnostic Test: holter electrocardiogram Diagnostic Test: blood pressure Other: relaxation sessions||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance|
|Actual Study Start Date :||November 9, 2017|
|Actual Primary Completion Date :||May 25, 2018|
|Actual Study Completion Date :||May 25, 2018|
Experimental: Complex Regional Pain Syndrome (CRPS)
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.
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:
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.
- high frequency index [ Time Frame: at 3 months ]measured by holter electrocardiogram.
- blood pressure [ Time Frame: at 3 months ]
- life quality of children [ Time Frame: at 3 months ]by questionnaire KIDSCREEN 52
- evaluation of pain [ Time Frame: at 3 months ]by questionnaire EVA
- evaluation of pain [ Time Frame: at 3 months ]by questionnaire DN4
- evaluation of pain [ Time Frame: at 3 months ]by questionnaire DEGR
- intensity of pain [ Time Frame: at 3 months ]with Eland Color Scale
- location of pain [ Time Frame: at 3 months ]with Eland Color Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309774
|CHU de Saint Etienne|
|Saint Etienne, France, 42055|
|Principal Investigator:||Vincent Gautheron, MD PhD||CHU Saint-Etienne|