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Trial record 6 of 119 for:    "Complex regional pain syndrome"

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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

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

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.


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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

Resource links provided by the National Library of Medicine


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.

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)

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.





Primary Outcome Measures :
  1. high frequency index [ Time Frame: at 3 months ]
    measured by holter electrocardiogram.


Secondary Outcome Measures :
  1. blood pressure [ Time Frame: at 3 months ]
  2. life quality of children [ Time Frame: at 3 months ]
    by questionnaire KIDSCREEN 52

  3. evaluation of pain [ Time Frame: at 3 months ]
    by questionnaire EVA

  4. evaluation of pain [ Time Frame: at 3 months ]
    by questionnaire DN4

  5. evaluation of pain [ Time Frame: at 3 months ]
    by questionnaire DEGR

  6. intensity of pain [ Time Frame: at 3 months ]
    with Eland Color Scale

  7. location of pain [ Time Frame: at 3 months ]
    with Eland Color Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
CHU de Saint Etienne
Saint Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Vincent Gautheron, MD PhD CHU Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03309774     History of Changes
Other Study ID Numbers: 1708124
2017-A02092-51 ( Other Identifier: ANSM )
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Children
Complex Regional Pain Syndrome
Relaxation
Bergès relaxation
Pain

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases