Chronic Non-inflammatory Pains in Rheumatopediatrics

NCT ID: NCT03740347

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-06

Study Completion Date

2018-11-06

Brief Summary

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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

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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)).

Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Juvenile idiopathic arthritis and chronic pain

Patients followed for juvenile idiopathic arthritis and chronic pain in Necker Hospital

Questionnaires

Intervention Type BEHAVIORAL

Response to questionnaires evaluating chronic pain and its repercussion :

* anxiety questionnaire (Revised Children's Manifest Anxiety Scale),
* depression questionnaire (Children's Depression Inventory score),
* sleepiness questionnaire (Pediatric Daytime Sleepiness Scale),
* quality of life questionnaire (Pediatric Quality of Life inventory score).

Interventions

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Questionnaires

Response to questionnaires evaluating chronic pain and its repercussion :

* anxiety questionnaire (Revised Children's Manifest Anxiety Scale),
* depression questionnaire (Children's Depression Inventory score),
* sleepiness questionnaire (Pediatric Daytime Sleepiness Scale),
* quality of life questionnaire (Pediatric Quality of Life inventory score).

Intervention Type BEHAVIORAL

Other Intervention Names

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Evaluation of the chronic pain repercussion in juvenile idiopathic arthritis

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maxime Goirand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Functional Unit of "Pain and Palliative Medicine" - Necker-Enfants malades Hospital

Locations

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Functional Unit of "Pain and Palliative Medicine"- Necker-Enfants malades Hospital

Paris, , France

Site Status

Countries

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France

References

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Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007 Mar 3;369(9563):767-778. doi: 10.1016/S0140-6736(07)60363-8.

Reference Type BACKGROUND
PMID: 17336654 (View on PubMed)

Consolaro A, Ravelli A. Paediatric rheumatology: Juvenile idiopathic arthritis--are biologic agents effective for pain? Nat Rev Rheumatol. 2013 Aug;9(8):447-8. doi: 10.1038/nrrheum.2013.108. Epub 2013 Jul 2.

Reference Type BACKGROUND
PMID: 23820859 (View on PubMed)

Tupper SM, Rosenberg AM, Pahwa P, Stinson JN. Pain intensity variability and its relationship with quality of life in youths with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):563-70. doi: 10.1002/acr.21850.

Reference Type BACKGROUND
PMID: 22972759 (View on PubMed)

Lalloo C, Stinson JN. Assessment and treatment of pain in children and adolescents. Best Pract Res Clin Rheumatol. 2014 Apr;28(2):315-30. doi: 10.1016/j.berh.2014.05.003.

Reference Type BACKGROUND
PMID: 24974065 (View on PubMed)

Duffield SJ, Miller N, Zhao S, Goodson NJ. Concomitant fibromyalgia complicating chronic inflammatory arthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2018 Aug 1;57(8):1453-1460. doi: 10.1093/rheumatology/key112.

Reference Type BACKGROUND
PMID: 29788461 (View on PubMed)

McErlane F, Beresford MW, Baildam EM, Chieng SE, Davidson JE, Foster HE, Gardner-Medwin J, Lunt M, Wedderburn LR, Thomson W, Hyrich KL; Childhood Arthritis Prospective Study (CAPS). Validity of a three-variable Juvenile Arthritis Disease Activity Score in children with new-onset juvenile idiopathic arthritis. Ann Rheum Dis. 2013 Dec;72(12):1983-8. doi: 10.1136/annrheumdis-2012-202031. Epub 2012 Dec 20.

Reference Type BACKGROUND
PMID: 23256951 (View on PubMed)

Reynolds CR. Concurrent validity of "What I think and feel:" the Revised Children's Manifest Anxiety Scale. J Consult Clin Psychol. 1980 Dec;48(6):774-5. doi: 10.1037//0022-006x.48.6.774. No abstract available.

Reference Type BACKGROUND
PMID: 7440835 (View on PubMed)

Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.

Reference Type BACKGROUND
PMID: 4089116 (View on PubMed)

Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.

Reference Type BACKGROUND
PMID: 10024117 (View on PubMed)

Drake C, Nickel C, Burduvali E, Roth T, Jefferson C, Pietro B. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children. Sleep. 2003 Jun 15;26(4):455-8.

Reference Type BACKGROUND
PMID: 12841372 (View on PubMed)

Other Identifiers

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2018-A02317-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP180230

Identifier Type: -

Identifier Source: org_study_id

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