Primary Objectives: 1.1: To evaluate the feasibility of determining sensory thresholds in patients with JIA using QST.1.2: To examine which sensory modalities are particularly affected in JIA patients compared to healthy controls in order to define…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain sensitivity levels of the QST battery: Pain thresholds for temperature
(hot,cold), pinprick, pressure, temporal summation of pinprick (*wind-up*), and
allodynia.
Secondary outcome
Detection sensitivity levels of the QST battery: temperature (warm, cold),
mechanical, and vibration.
Background summary
Juvenile idiopathic arthritis (JIA) is a common childhood rheumatic disease
potentially resulting in long-term disability persisting into adulthood in more
than one-third of the patients. Acute pain is a clinically significant symptom
of JIA, with pain persisting in approximately 40% of JIA patients for months to
years. This 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.
A cornerstone of investigating both acute and chronic pain in JIA patients is
the measurement of pain. Recently a valid and reliable methodology has been
developed that can objectively and accurately assess pain: quantitative sensory
testing (QST). In adult populations, this methodology has been used extensively
and has proven to produce intra-individually repeatable and internationally
comparable data. A validated standardized quantitative sensory testing (QST)
protocol has been developed which can reliably be used in healthy children over
5 years. It is currently unknown if QST testing is also feasible in JIA
patients and no reference data exist..
Study objective
Primary Objectives:
1.1: To evaluate the feasibility of determining sensory thresholds in patients
with JIA using QST.
1.2: To examine which sensory modalities are particularly affected in JIA
patients compared to healthy controls in order to define an optimal set of
QST-tests in future studies.
Secondary Objectives:
To evaluate the role of age, sex, JIA subtype and medication use in QST
findings.
Study design
This is a monocenter observational cross-sectional, case-control study.
Study burden and risks
Benefits:
Patients with JIA often suffer from (severe) pain. Being able to reliably
measure pain in this group makes it possible to better study the mechanisms
driving pain, particularly the transition from acute to chronic pain. A better
understanding of these mechanisms can lead to new treatments to decrease pain
in patients with JIA.
Risk assessment:
The potential risks are negligible and the burden of study participation is
minimal. Sensory tests are all protocolized and considered safe, with no risk
for serious injuries. No tissue will be damaged, since 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. The pain tests described in
this protocol have been used for research previously.
Group relatedness:
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.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Healthy controls will be matched to JIA patients based on age and sex.
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- From 6 to 17 years of age
- Ability to speak Dutch
-Be diagnosed with active JIA by their treating physician as defined by the ILAR-classification and patient reported pain rating greater than 10 (on a 0-100mm scale).
- The most severe inflammation must be in the knee;Healthy controls must meet all of the following criteria:
- From 6 to 17 years of age
- Ability to speak Dutch
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
In the case of patients:
- When there is any serious injury to the body regions to be tested
- Severe comorbidity including but not limited to cystic fibrosis, cancer, inflammatory bowel disease; history of drug or alcohol abuse; severe psychiatric disorder or dysfunction (e.g., major depression or generalized anxiety disorder)
- Inability to understand the instructions;In the case of healthy controls:
- When there is any serious injury to the body regions to be tested
- Health problems requiring medical treatment, history of drug or alcohol abuse; severe psychiatric disorder or dysfunction (e.g., major depression or generalized anxiety disorder)
- 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 | NL44699.041.13 |