The aim of this exploratory study is to compare the hemodynamic response as determined by the HandScan between patients with OA and RA, and to study these hemodynamic responses in relation to disease specific underlying joint pathology (synovial…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Hemodynamic response, as provided standard by the HandScan (continuous value,
0-3 per joint).
* Inflammation defined by US: Gray scale (0-3 per joint) and Power Doppler (0-3
per joint)
Secondary outcome
Difference in disease characteristics detectable by US; bone osteophytes (0-1),
tenosynovitis (0-1).
Background summary
Osteoarthritis (OA) of the hand is one of the most prevalent OA phenotypes and
occurs frequently in older individuals, especially women. In the general
population aged >55 years, 56% of individuals have radiographic signs of hand
OA, 16% experiences pain, and 3.3% experiences disability. Pain is a major
burden of hand OA. It is a variable symptom, and is associated with structural
damage (osteophytosis, joint space narrowing) and inflammation.
In OA, joint inflammation is increasingly considered an important target for
treatment to prevent tissue damage.
Recently, a new method has been proposed for measuring inflammation of the hand
and wrist joints in rheumatoid arthritis (RA). The technology is based on
quantifying the inflammation related hemodynamics around the joint in response
to temporarily obstructed venous blood flow.
For RA, taking all relevant joints together, a good agreement between the
HandScan values and US measurements of inflammation is found (r=0.71).
HandScan measurements were even superior compared to physical examination
(r=0.53), assuming US as a more sensitive (gold) standard for joint
inflammation. Importantly, in patients with subclinical disease activity
(inflammation not detectable by physical examination), there was a correlation
between HandScan values and MRI synovitis score (r=0.57, p=0.008). Using US as
a gold standard, a cut-off of 0,26 defines inflammation in hand joints of RA
patients with the HandScan with a sensitivity of 77% and a specificity of 74%.
In the present explorative study we will evaluate for the first time the
characteristics of the hemodynamic response as measured by the HandScan in OA
and compare these characteristics to RA with the use of US to define
differences in underlying pathology.
Study objective
The aim of this exploratory study is to compare the hemodynamic response as
determined by the HandScan between patients with OA and RA, and to study these
hemodynamic responses in relation to disease specific underlying joint
pathology (synovial tissue inflammation, bone changes, and peri-articular soft
tissue inflammation) as determined by US.
Primary:
To explore whether the hemodynamic response, as measured by the HandScan, is
different for OA and RA, because of differences in underlying joint pathology,
as measured by US.
Secondary:
To explore whether the outcome of the HandScan measurements are associated with
disease related self-reported pain and tender and swollen joints by manual
clinical examination,
Study design
This study is an exploratory cross-sectional, non-therapeutic observational
study.
Intervention
Per patient a HandScan measurement, an US of hands and wrists and physical
examination is performed.
Study burden and risks
Risk for patients is negligible, and there is no direct benefit for the
patients. However, benefit for future clinical practice is anticipated. This
pilot study will investigate hemodynamic response in joints of patients with OA
in comparison to RA by use of the Handscan which is a first step towards a
potential novel method for quick and objective detection of joint inflammation
in hand OA in addition to RA.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
* Diagnosed with Rheumatoid Arthritis according to ACR/EULAR 2010 criteria or with OsteoArthritis according to ACR 1990 criteria.
* Age between 18 and 90 years
* * 1 swollen hand joints
* Ability to give informed consent
Exclusion criteria
* Other diagnosis than OA or RA that can explain pain or swelling in the hand joints, such as other inflammatory rheumatic diseases (psoriatic arthritis, gout).
* Intra-articular treatment with steroid injection within 3 months of assessments of the joints
* Trauma or surgery of one of the hand joints within 6 months of assessments of the joints
* Light sensitivity, i.e. Erythropoietic protoporphyria or patients on photodynamic therapy
* Artificial joints of wrist/hand
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 | NL50848.041.15 |