Clinical trial NCT03740347: Chronic Non-inflammatory Pains in Rheumatopediatrics
Official title: Chronic Non-inflammatory Pains in Rheumatopediatrics
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Juvenile Idiopathic Arthritis
Keywords: Juvenile idiopathic arthritis
chronic pain
anxiety
depression
sleepiness
quality of life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 12 years of age followed for juvenile idiopathic arthritis in the reference center at Necker-Enfants malades Hospital (RAISE)

Brief summary: The purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity.

Secondary objectives are, first to determine intensity of pain and its repercussion in daily life and second to determine risk factor of chronic pain.

Detailed description: Juvenile idiopathic arthritis is the most frequent pathology in paediatric rheumatology clinic. Pain is an important symptom in paediatric rheumatology. It is actually poorly studied and is not evaluate in disease activity score like the Juvenile Arthritis Disease Activity Score (JADAS). It is source of handicap, social and psychological distress and greatly contribute to poor quality of life. Chronic pain is frequently multifactorial, even in inflammatory disease. In adult population, rheumatologists have shown an association between inflammatory disease like spondylarthritis or rheumatology polyarthritis and fibromyalgia.

There is no specific data on chronic pain in juvenile idiopathic arthritis. Pain is mostly evaluated by the Visual Analogue Scale (VAS) with no evaluation of pain repercussion on daily life or its chronicity. This study's primary objective is to determine the frequency of chronic pain and its relationship with disease activity. Secondaries objectives are to determine repercussion of pain in daily life, and risk factor of chronic pain.

To responded to this objective, we will conduct a transversal study in a paediatric rheumatology refence centre in Necker-Enfants malades Hospital. We will include all patients between 12 and 18 years old followed in our centre for any type of juvenile idiopathic arthritis.

Patients will be evaluated as usual by their paediatrics rheumatologist during a follow-up consultation or hospitalisation with the used of the clinical JADAS. Patient accepting to participate the study will be given a paper questionnaire evaluating chronic pain, its repercussion, anxiety (by the used of the Revised Children's Manifest Anxiety Scale (RCMAS score)), depression (by the used of the Children's Depression Inventory (CDI score)), Sleepiness (by the used of the Pediatric Daytime Sleepiness Scale (PDSS score)) and quality of life (by the used of the measurement model for the Pediatric Quality of Life inventory (PedQL score)).

Eligibility criteria: Inclusion Criteria:

* Child from 12 to 17 years old
* Follow-up to Necker Hospital by a rheumatologist at the reference center for juvenile idiopathic arthritis (RAISE), regardless of the form
* Not opposed to participating in the study

Exclusion Criteria:

No exclusion criteria

Primary outcomes:
measure: Frequency of chronic pain and its relationship with disease activity
timeFrame: Day 0
Secondary outcomes:
measure: Chronic pain and disease repercussions
timeFrame: Day 0
measure: Repercussions of pain on patient anxiety
timeFrame: Day 0
measure: Repercussions of pain on depression symptoms
timeFrame: Day 0
measure: Repercussions of pain on quality of life
timeFrame: Day 0
measure: Repercussions of pain on patient daytime sleepiness
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Functional Unit of "Pain and Palliative Medicine"- Necker-Enfants malades Hospital
Study officials:
affiliation: AP-HP, Functional Unit of "Pain and Palliative Medicine" - Necker-Enfants malades Hospital
name: Maxime Goirand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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