Complex Regional Pain Syndrome Type INCT03309774
Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
A study testing questionnaires, holter electrocardiogram and blood pressure in people with Complex Regional Pain Syndrome Type I, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type I
- What is being tested?
- questionnaires, holter electrocardiogram and blood pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2017to 25 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Complex Regional Pain Syndrome Type I
- Being tested
- questionnaires, holter electrocardiogram, blood pressure, relaxation sessions
- Keywords
- Children, Complex Regional Pain Syndrome, Relaxation, Bergès relaxation, Pain
- Medical subject headings
- Complex Regional Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesDiagnostic 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 electrocardiogramDiagnostic test
Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.
blood pressureDiagnostic test
Blood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after relaxation sessions.
relaxation sessionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Complex Regional Pain Syndrome (CRPS) | Experimental | 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. Receives: Diagnostic Test: questionnaires; Diagnostic Test: holter electrocardiogram; Diagnostic Test: blood pressure; Other: relaxation sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
high frequency index
measured by holter electrocardiogram.
Measured: at 3 months
Secondary outcomes (7)
blood pressure
Measured: at 3 months
life quality of children
by questionnaire KIDSCREEN 52
Measured: at 3 months
evaluation of pain
by questionnaire EVA
Measured: at 3 months
evaluation of pain
by questionnaire DN4
Measured: at 3 months
evaluation of pain
by questionnaire DEGR
Measured: at 3 months
intensity of pain
with Eland Color Scale
Measured: at 3 months
location of pain
with Eland Color Scale
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start9 Nov 2017
- Primary completion25 May 2018
- Study completion25 May 2018
Why it stopped: failing of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome Type IStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Gautheron, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309774
- Sponsor's protocol ID
- 1708124
- Other IDs
- 2017-A02092-51
- Status last verified
- Mar 2019
- First submitted
- 5 Oct 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
- ClinicalTrials.gov ID
- NCT03309774
- Acronym / sponsor ID
- 1708124
- Conditions
- Complex Regional Pain Syndrome Type I
- Keywords
- Children, Complex Regional Pain Syndrome, Relaxation, Bergès relaxation, Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failing of recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complex Regional Pain Syndrome (CRPS) | Experimental | Diagnostic Test: questionnaires, Diagnostic Test: holter electrocardiogram, Diagnostic Test: blood pressure, Other: relaxation sessionsChildren 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesChildren 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 | Complex Regional Pain Syndrome (CRPS) |
| holter electrocardiogramChildren with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions. | Diagnostic test | Complex Regional Pain Syndrome (CRPS) |
| blood pressureBlood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after relaxation sessions. | Diagnostic test | Complex Regional Pain Syndrome (CRPS) |
| relaxation sessionsChildren 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. | Other | Complex Regional Pain Syndrome (CRPS) |
Primary outcome
high frequency index
Time frame: at 3 months
measured by holter electrocardiogram.
7 secondary outcomes
blood pressure
Time frame: at 3 months
life quality of children
Time frame: at 3 months
evaluation of pain
Time frame: at 3 months
evaluation of pain
Time frame: at 3 months
evaluation of pain
Time frame: at 3 months
intensity of pain
Time frame: at 3 months
location of pain
Time frame: at 3 months
Results and safety
The study was stopped early (reason given: failing of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Complex Regional Pain Syndrome Type I
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Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
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RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
RecruitingObservational study
CRPS-RISE Outcomes Registry
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Recruiting
ESWT for CRPS-I After Distal Radius Fracture
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Gautheron, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires, holter electrocardiogram and blood pressure in people with Complex Regional Pain Syndrome Type I, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: failing of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high frequency index (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.