- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03309774
Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Saint Etienne, France, 42055
- CHU de Saint Etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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:
Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.
Blood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
high frequency index
Time Frame: at 3 months
|
measured by holter electrocardiogram.
|
at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood pressure
Time Frame: at 3 months
|
at 3 months
|
|
life quality of children
Time Frame: at 3 months
|
by questionnaire KIDSCREEN 52
|
at 3 months
|
evaluation of pain
Time Frame: at 3 months
|
by questionnaire EVA
|
at 3 months
|
evaluation of pain
Time Frame: at 3 months
|
by questionnaire DN4
|
at 3 months
|
evaluation of pain
Time Frame: at 3 months
|
by questionnaire DEGR
|
at 3 months
|
intensity of pain
Time Frame: at 3 months
|
with Eland Color Scale
|
at 3 months
|
location of pain
Time Frame: at 3 months
|
with Eland Color Scale
|
at 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1708124
- 2017-A02092-51 (OTHER: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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