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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-09

Study Completion Date

2018-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

BioFeedBack Breathing Training Influence Cardiac Autonomic Nervous System in Children With Cerebral-Palsy.

NCT01872507

Cerebral Palsy Autonomic Nerveus System

COMPLETED NA

Incontinence and MRI Results in Children with Cerebral Palsy

NCT05060211

Cerebral Palsy Lower Urinary Tract Symptoms

COMPLETED

Study of Parental Stress and Care Consumption Until 24 Months Corrected Age of Infants at a High Risk of Developmental Delay, After Discharge From Neonatal Intensive Care

NCT05233371

Cerebral Palsy

RECRUITING

Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.

NCT02229630

Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction

COMPLETED NA

Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury

NCT01599455

Spinal Cord Injury

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complex Regional Pain Syndrome Type I

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

questionnaires

Intervention Type 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:

* Questionnaire KIDSCREEN 52
* Visual Analogue Scale (EVA)
* Neuropathic Pain 4 (DN4)
* Pain of the child Gustave Roussy (DEGR)

holter electrocardiogram

Intervention Type DIAGNOSTIC_TEST

Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.

blood pressure

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DIAGNOSTIC_TEST

holter electrocardiogram

Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No