Chronic Non-inflammatory Pains in Rheumatopediatrics

Juvenile Idiopathic Arthritis Clinical Trial

— RHUMEDOL  

Official title:

Chronic Non-inflammatory Pains in Rheumatopediatrics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03740347
• Other study ID #: APHP180230
• Secondary ID: 2018-A02317-48
• Status: Withdrawn
• Start date: December 2018
• Est. completion date: March 2019

Study information

• Verified date: January 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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).

Locations

Country	Name	City	State
France	Functional Unit of "Pain and Palliative Medicine"- Necker-Enfants malades Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Secondary	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.	Day 0
Secondary	Repercussions of pain on patient anxiety	Anxiety symptoms will be assessed with the Revised Children's Manifest Anxiety Scale (RCMAS) questionnaire	Day 0
Secondary	Repercussions of pain on depression symptoms	Depression symptoms will be assessed with the Children's Depression Inventory (CDI) questionnaire	Day 0
Secondary	Repercussions of pain on quality of life	Anxiety symptoms will be assessed with the Pediatric Quality of Life inventory (PedQL) questionnaire	Day 0
Secondary	Repercussions of pain on patient daytime sleepiness	Anxiety symptoms will be assessed with the Pediatric Daytime Sleepiness Scale (PDSS score)	Day 0