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

Complex Regional Pain Syndrome Type I Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03309774
• Other study ID #: 1708124
• Secondary ID: 2017-A02092-51
• Status: Terminated
• Phase: N/A
• Start date: November 9, 2017
• Est. completion date: May 25, 2018

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome Type I
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

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: Questionnaire KIDSCREEN 52 Visual Analogue Scale (EVA) Neuropathic Pain 4 (DN4) Pain of the child Gustave Roussy (DEGR)
• holter electrocardiogram
Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.
• 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.

Locations

Country	Name	City	State
France	CHU de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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