To investigate if healthy subjects have US-detected features of *inflammation' in order to develop an age-matched homogenous definition of normal variants of wrist, thumb base, metacarpal phalangeal, interphalangeal and metatarsal phalangeal…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence of inflammatory US features in joints and tendons of healthy
subjects
Secondary outcome
The presence of osteophytes detected by US in joints of healthy subjects.
The relationship between the presence of inflammatory US features and
osteophytes detected by US
The relationship between the presence of inflammatory US features in healthy
subjects and demographic characteristics (i.e. age, gender and body mass index)
Background summary
Early initiation of treatment of Rheumatoid Arthritis (RA) is beneficial as it
results in less joint damage during the subsequent disease course. In order to
treat patients early, RA has to be recognized early. At present, recognition is
done with physical examination; joints are palpated to determine whether
arthritis is present. In studies in patients with early arthritis,
musculoskeletal US had an additive value to physical examination by detecting
subclinical inflammation, that is also associated with progression to
structural damage over time. This suggests that US is a valuable prognostic
tool.
Early initiation of treatment of Rheumatoid Arthritis (RA) is beneficial as it
leads to less joint damage during the disease course. Therefore, early
recognition is important, preferable already in the preclinical phase of the
disease.
In Studies in patients with arthralgia at risk of developing RA, high
resolution imaging has shown to be capable of detecting subclinical arthritis
-and also tenosynovitis- that can attribute to the early identification of
patients with RA.
However, in healthy subjects, subtle inflammatory features can be present in
hand and foot joints, which are not disease related. In order to be able to
identify early phases of RA using imaging modalities, a reference of normal
variations is necessary. For MRI these references have been described recently,
but unfortunately, standard reference values for US are lacking at the moment.
Study objective
To investigate if healthy subjects have US-detected features of *inflammation'
in order to develop an age-matched homogenous definition of normal variants of
wrist, thumb base, metacarpal phalangeal, interphalangeal and metatarsal
phalangeal joints for standard reference values.
Study design
This is a cross-sectional single centre study that will be performed by the
Department of Rheumatology of the Leiden University Medical Centre. Healthy
subjects (200 in total) of different age categories, without complaints of hand
and feet, will be recruited. An US examination will be performed of both hands,
wrists and feet during one single study visit. The total duration of the study
will be approximately 12-24 months.
Study burden and risks
Healthy volunteers are requested to come to the hospital for the study visit.
The study visit lasts for approximately 50-60 minutes.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
* Age * 18 years
* No previous prolonged and/or current symptoms of wrist, thumb base, metacarpal, interphalangeal and metatarsal joints
* Written informed consent
Exclusion criteria
* No written informed consent
* Previous/current inflammatory joint disease (including crystal arthropathy).
* Visual analogue score (VAS) for current joint pain > 10/100.
* Any history of joint trauma in the last month.
* Fulfilling hand osteoarthritis according to the American College of Rheumatology clinical classification criteria.
* Any clinical joint inflammation, suggestive of inflammatory rheumatic disease, as identified by a physician.
* Previous or current inflammatory bowel disease.
* History of culture-proven enteric and/or genitourinary infection in the last month (assessed at history taking).
* Current or previous corticosteroids use in the last 4 weeks.
* Current non-steroidal anti-inflammatory drugs (NSAID) use (<7 days).
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL63182.058.17 |