The key objective of this proposal is to develop a prediction tool, which will enable clinicians to detect an increased risk of developing chronic pain in JIA at an early stage of the disease. This tools consists of an assay for GRK2 expression.…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the difference in pain rating between baseline, i.e. time
of diagnosis, (t0) and at 3 (t1), 6 (t2) and 12 months (t3) after diagnosis,
dichotomized in clinical relevant change of VAS-score, defined by a change in
VAS score of either >= 20 mm or >= 30%.
Secondary outcome
Secondary endpoints are:
1. monocyte/macrophage GRK2 expression
2. LPS-induced monocyte p38 activation
3. cytokine profiles (ratio between pro- and anti-inflammatory cytokine
responses)
4. QST profile
5. pain favouring cognition
6. medication (subgroups of medication, NSAID's, MTX, TNF-α blocking
biologicals, non-TNF-α blocking biologicals), as a proxy of severity and
duration of active JIA
Background summary
Juvenile idiopathic arthritis (JIA) is a common childhood rheumatic disease
which results in long-term disability persisting into adulthood in more than
one-third of the patients. Acute pain is a clinically significant symptom of
JIA, and pain persists for months to years in approximately 40% of JIA
patients. This persisting, chronic pain is hard to treat. Identification of
those patients at risk of developing chronic pain is needed to be able to start
early treatment aimed at preventing the transition from acute to chronic pain.
Study objective
The key objective of this proposal is to develop a prediction tool, which will
enable clinicians to detect an increased risk of developing chronic pain in JIA
at an early stage of the disease. This tools consists of an assay for GRK2
expression. This prediction tool will enable to tailor the treatment of JIA to
minimize the risk of chronification of acute inflammatory pain
Study design
This is a monocenter observational longitudinal study
Study burden and risks
Patients with JIA often suffer from (severe) pain. Being able to identify those
patients with JIA who are at risk of developing chronic pain will enable the
use of treatment specifically aimed at reducing the transition from acute to
chronic pain, without risking overtreatment for the JIA-group at large.
The potential risks are negligible and the burden of study participation is
minimal, comparable with the routine physical examination by the pediatric
rheumatologist. Sensory tests are all protocolized and considered safe, with no
risk of serious injuries. The measurement devices are designed to operate
within margins that will not cause tissue damage. The level of discomfort is
minimal, since the measurements stop the moment the subject notices the
sensation to become painful. Also, the extra vial of blood taken is timed to
coincide with the routine venepuncture as part of standard of care. The
questionnaires are chosen to be as concise as possible. JIA is a disorder which
presents itself in childhood with a severe risk of continuing in adulthood. The
participation of children with JIA is mandatory to gain more knowledge of pain
mechanisms in this syndrome. There are no costs to the subject for
participating in this study. There is no direct benefit for the individual who
will participate in the study. The benefits in terms of newly gained knowledge
are potentially very valuable as this study will correlate the occurrence of
chronic pain to a variety of immunological biomarkers and cognitive
determinants.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
- Age between 6 to 17 years
- Ability to speak and understand Dutch
- having been diagnosed with active JIA by their treating physician as defined by the ILAR-classification
- having the most severe arthritis in either face, hand, knee or foot
Exclusion criteria
- monoarthritis of the hip
- serious injury to the body regions to be tested
- Health problems such as Cystic Fibrosis, cancer, inflammatory bowel disease, drug or alcohol abuse; severe psychiatric disorder or dysfunction (e.g., major depression or generalized anxiety disorder requiring medical treatment)
- Inability to understand the instructions
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49224.041.14 |