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WithdrawnNCT03740347RHUMEDOLUpdated Apr 3, 2026

Chronic Non-inflammatory Pains in Rheumatopediatrics

An observational study in Juvenile Idiopathic Arthritis, sponsored by Assistance Publique - Hôpitaux de Paris. Withdrawn at 1 site in France. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Why this study was withdrawn
Withdrawn study
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
0
Ages
12 Years to 17 Years
Sex
All
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Study 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.

Read the 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)).

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Conditions studied

  • Juvenile Idiopathic Arthritis

Keywords

  • Juvenile idiopathic arthritis
  • chronic pain
  • anxiety
  • depression
  • sleepiness
  • quality of life
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In context

Arthritis, Juvenile

365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.

Browse Arthritis, Juvenile studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
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)

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

  • 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

Exclusion Criteria:

No exclusion criteria

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Juvenile idiopathic arthritis and chronic pain

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

    Behavioral: Questionnaires

Interventions

  • BehavioralQuestionnaires

    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).

    Also known as: Evaluation of the chronic pain repercussion in juvenile idiopathic arthritis

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What researchers measure

Primary outcomes

  1. Frequency of chronic pain and its relationship with disease activity

    Chronic pain will be defined by the presence of recurrent or permanent moderate pain (Visual Analogue Scale (VAS) \> 3 / 10), present more than 3 days a week. Disease activity will be evaluated by the clinical Juvenile Arthritis Disease Activity Score (JADAS) and the definition of three groups: inactive disease, minimal disease activity and active disease.

    Time frame: Day 0

Secondary outcomes

  1. Chronic pain and disease repercussions

    Chronic pain and disease repercussion will be assessed by a paper questionnaire evaluation repercussion on scholarship, sports, sleep and social interaction.

    Time frame: Day 0

  2. Repercussions of pain on patient anxiety

    Anxiety symptoms will be assessed with the Revised Children's Manifest Anxiety Scale (RCMAS) questionnaire

    Time frame: Day 0

  3. Repercussions of pain on depression symptoms

    Depression symptoms will be assessed with the Children's Depression Inventory (CDI) questionnaire

    Time frame: Day 0

  4. Repercussions of pain on quality of life

    Anxiety symptoms will be assessed with the Pediatric Quality of Life inventory (PedQL) questionnaire

    Time frame: Day 0

  5. Repercussions of pain on patient daytime sleepiness

    Anxiety symptoms will be assessed with the Pediatric Daytime Sleepiness Scale (PDSS score)

    Time frame: Day 0

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Study locations

1 site
  • Functional Unit of "Pain and Palliative Medicine"- Necker-Enfants malades Hospital
    Paris, 75015, France
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References and documents

Publications

  • Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007 Mar 3;369(9563):767-778. doi: 10.1016/S0140-6736(07)60363-8. PubMed 17336654 ↗
  • 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. PubMed 23820859 ↗
  • 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. PubMed 22972759 ↗
  • 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. PubMed 24974065 ↗
  • 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. PubMed 29788461 ↗
  • 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. PubMed 23256951 ↗
  • 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. PubMed 7440835 ↗
  • Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available. PubMed 4089116 ↗
  • 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. PubMed 10024117 ↗
  • 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. PubMed 12841372 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2018 to primary completion in Nov 2018, 0 months.

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

Registered
Nov 2, 2018
First posted
Nov 14, 2018
StartActual
Nov 6, 2018
Primary completionActual
Nov 6, 2018
CompletionActual
Nov 6, 2018
Last update
Apr 3, 2026
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 Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03740347
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Nov 14, 2018
Start date
Nov 6, 2018
Primary completion
Nov 6, 2018
Completion
Nov 6, 2018
Last update
Apr 3, 2026

Study contacts

Maxime Goirand, MD, PhD
principal investigator · AP-HP, Functional Unit of "Pain and Palliative Medicine" - Necker-Enfants malades Hospital

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 withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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