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Chronic Non-inflammatory Pains in Rheumatopediatrics (RHUMEDOL)

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ClinicalTrials.gov Identifier: NCT03740347
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Juvenile Idiopathic Arthritis Behavioral: Questionnaires

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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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Chronic Non-inflammatory Pains in Rheumatopediatrics
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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 Name: Evaluation of the chronic pain repercussion in juvenile idiopathic arthritis




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Repercussions of pain on depression symptoms [ Time Frame: Day 0 ]
    Depression symptoms will be assessed with the Children's Depression Inventory (CDI) questionnaire

  4. 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

  5. Repercussions of pain on patient daytime sleepiness [ Time Frame: Day 0 ]
    Anxiety symptoms will be assessed with the Pediatric Daytime Sleepiness Scale (PDSS score)



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   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)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740347


Contacts
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Contact: Maxime Goirand, MD, PhD +33 (0)1 44 49 42 84 maxime.goirand@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr

Locations
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France
Functional Unit of "Pain and Palliative Medicine"- Necker-Enfants malades Hospital Not yet recruiting
Paris, France, 75015
Contact: Pierre Quartier, MD, PhD    +33 (0)1 44 49 48 28    pierre.quartier@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Maxime Goirand, MD, PhD AP-HP, Functional Unit of "Pain and Palliative Medicine" - Necker-Enfants malades Hospital

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03740347     History of Changes
Other Study ID Numbers: APHP180230
2018-A02317-48 ( Registry Identifier: ID-RCB )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Juvenile idiopathic arthritis
chronic pain
anxiety
depression
sleepiness
quality of life

Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases