Chronic Non-inflammatory Pains in Rheumatopediatrics (RHUMEDOL)

March 30, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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)).

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Juvenile idiopathic arthritis and chronic pain
Patients followed for juvenile idiopathic arthritis and chronic pain in Necker Hospital
Behavioral: 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).
Other Names:
  • Evaluation of the chronic pain repercussion in juvenile idiopathic arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of chronic pain and its relationship with disease activity
Time Frame: Day 0

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.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pain and disease repercussions
Time Frame: Day 0
Chronic pain and disease repercussion will be assessed by a paper questionnaire evaluation repercussion on scholarship, sports, sleep and social interaction.
Day 0
Repercussions of pain on patient anxiety
Time Frame: Day 0
Anxiety symptoms will be assessed with the Revised Children's Manifest Anxiety Scale (RCMAS) questionnaire
Day 0
Repercussions of pain on depression symptoms
Time Frame: Day 0
Depression symptoms will be assessed with the Children's Depression Inventory (CDI) questionnaire
Day 0
Repercussions of pain on quality of life
Time Frame: Day 0
Anxiety symptoms will be assessed with the Pediatric Quality of Life inventory (PedQL) questionnaire
Day 0
Repercussions of pain on patient daytime sleepiness
Time Frame: Day 0
Anxiety symptoms will be assessed with the Pediatric Daytime Sleepiness Scale (PDSS score)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Maxime Goirand, MD, PhD, AP-HP, Functional Unit of "Pain and Palliative Medicine" - Necker-Enfants malades Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2018

Primary Completion (Actual)

November 6, 2018

Study Completion (Actual)

November 6, 2018

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180230
  • 2018-A02317-48 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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