ClinicalTrials.gg
TerminatedNCT03309774Updated Mar 21, 2019

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

An interventional study of questionnaires and holter electrocardiogram in Complex Regional Pain Syndrome Type I, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2019-03-21.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Basic science

Why this study was terminated
failing of recruitment

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Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
6 Years to 16 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 17 studies in Complex Regional Pain Syndromes with a site in France — 6 open to participants now, 6 under way, none of them phase 3. Complex Regional Pain Syndromes · France.

Enrollment
13th of 13
4 · median 60
Started
2017
with 1 other
No phase
10 of 17
4 open now
Registered
5th of 17
by date
Lead sponsor
2 of 17
Centre Hospitalier Universitaire de Saint Etienne

Among the 17 studies in Complex Regional Pain Syndromes with a site in France, this one is the 13th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2017, is one of 10 with no phase, and was the 5th registered.

Complex Regional Pain Syndromes

206 studies on the registry are indexed under Complex Regional Pain Syndromes; 54 are open to participants now.

Browse Complex Regional Pain Syndromes studies →

Open to participants now

6 of the 17 studies in Complex Regional Pain Syndromes with a site in France are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.

This study: 6 Years to 16 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Complex Regional Pain Syndrome Type I

Keywords

  • Children
  • Complex Regional Pain Syndrome
  • Relaxation
  • Bergès relaxation
  • Pain
04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • 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 · Diagnostic Test: holter electrocardiogram · Diagnostic Test: blood pressure · Other: relaxation sessions

Interventions

  • Diagnostic testquestionnaires

    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 testholter electrocardiogram

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

  • Diagnostic testblood pressure

    Blood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after relaxation sessions.

  • Otherrelaxation 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.

06

What researchers measure

Primary outcomes

  1. high frequency index

    measured by holter electrocardiogram.

    Time frame: at 3 months

Secondary outcomes

  1. blood pressure

    Time frame: at 3 months

  2. life quality of children

    by questionnaire KIDSCREEN 52

    Time frame: at 3 months

  3. evaluation of pain

    by questionnaire EVA

    Time frame: at 3 months

  4. evaluation of pain

    by questionnaire DN4

    Time frame: at 3 months

  5. evaluation of pain

    by questionnaire DEGR

    Time frame: at 3 months

  6. intensity of pain

    with Eland Color Scale

    Time frame: at 3 months

  7. location of pain

    with Eland Color Scale

    Time frame: at 3 months

07

Study locations

1 site
  • CHU de Saint Etienne
    Saint Etienne, 42055, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in May 2018, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2017
First posted
Oct 16, 2017
StartActual
Nov 9, 2017
Primary completionActual
May 25, 2018
CompletionActual
May 25, 2018
Last update
Mar 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03309774
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Nov 9, 2017
Primary completion
May 25, 2018
Completion
May 25, 2018
Last update
Mar 21, 2019

Study contacts

Vincent Gautheron, MD PhD
principal investigator · CHU Saint-Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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