NCT02547415

Brief Summary

Medically unexplained chronic pain - without identifiable somatic origin - is yet an insufficiently known and explored field in children and adolescents by international clinical works. This research aims to characterize somatic, psychological, psychopathological and environmental (particularly attachment styles and family functioning) processes trough an observational study with three pain management centers. The study concerns children and adolescents from 7 to 17 years old, suffering of medically unexplained chronic pain and their parents who are referred to a pain center. It is composed of a somatic, psychological and family functioning assessment on the one hand and psychopathological and attachment evaluation on the other hand.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

September 9, 2015

Last Update Submit

September 14, 2021

Conditions

Keywords

Pain, Chronicchildren

Outcome Measures

Primary Outcomes (1)

  • Explanatory factors for pain

    Environmental, familial, personal factors in children with chronic pain

    1 month

Study Arms (1)

patients with questionnaires and psychological testing

children and adolescents with chronic pain without proven medical cause, type painful somatic complaints

Other: questionnaires and psychological testing

Interventions

Child/adolescent and parents interview and consultation with both a physician and a psychologist for a somatic and pain indicators assessment within an usual setting. Then, parents and child or adolescent are interviewed separately using different psychological instruments with only a psychologist: * Psychological (cognitive and projective evaluation) : Intellectual Quotient, mental flexibility, projective evaluation with Rorschach and Thematic Apperception Test, parents and children attachment questionnaires * Psychopathological: anxiety and depression questionnaires, psychiatric disorders evaluation, quality of life, life events questionnaires, family functioning interview.

patients with questionnaires and psychological testing

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescent with chronic pain

You may qualify if:

  • Children and adolescent with chronic pain no proven medical cause, type of painful somatic complaints within the scope of one of the following diagnoses to ICD-10 (International Classification of Diseases) and DSM-IV and DSM-V (Diagnostic and Statistical Manual of Mental Disorders) to somatoform disorders, distinguishing between :
  • pain disorder
  • somatoform disorder
  • undifferentiated somatoform disorder
  • Addressed to the pain centers or in pediatric chronic pain services hosting children.
  • being fluently French-speaking and French-reading

You may not qualify if:

  • presence of current or past organic pathology including migraines and epilepsy, which may interfere with somatic expression of studied disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospices Civils de LYON

Bron, 69500, France

Location

Hopital TROUSSEAU

Paris, 75012, France

Location

Hopital NECKER

Paris, 75015, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Surveys and QuestionnairesPsychological Tests

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavioral Disciplines and Activities

Study Officials

  • Anne-Marie PERRIN

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 11, 2015

Study Start

January 22, 2015

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations