The current study aims to gain better insight into the pathophysiology of the aberrant inflammatory response in CRPS. The evaluation of the role of pro-inflammatory and anti-inflammatory mediators in response to a microtrauma may generate important…
ID
Source
Brief title
Condition
- Injuries NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome are the differences between patients and controls with respect
to cytokine profiles, de availability and amount of myeloperoxidase and the
total amount of Gc-globulin and 1,25(OH)2vitaminD3.
Secondary outcome
Secondary outcome is the difference within patients when comparing between the
affected and the unaffected arm. Another secondary outcome is the difference
within control subjects when comparing between both arms.
Background summary
CRPS frequently follows trauma, which can be minimal or severe. Several
features of CRPS in reaction to this trauma, such as pain, changes in skin
blood flow and temperature, sweat secretion and swelling, suggest an
inflammatory origin. Compelling evidence suggests involvement of C- and Aδ
fibers of sensory nerves (neurogenic inflammation) and local immune system of
the skin. However, key factors that mediate this aberrant inflammatory response
have not yet been identified. Current research is aims to provide more insight
into this matter.
Study objective
The current study aims to gain better insight into the pathophysiology of the
aberrant inflammatory response in CRPS. The evaluation of the role of
pro-inflammatory and anti-inflammatory mediators in response to a microtrauma
may generate important information on the biological pathways involved in CRPS.
Study design
Patients (n=30) and controls (n=30) are each randomized into three groups. Skin
windows are created at the volar surface of the forearm by dermal abrasion,
which continues until capillaries are seen but ceases before bleeding starts.
These skin windows are overlaid with filter paper containing either saline
alone (group 1), or saline containing LTA (group 2) or lipid A (group 3). The
last two groups are used to stimulate the inflammatory response.
Two skin windows per arm are needed. One filter paper per arm is removed after
30 minutes for measurements of baseline situation, and replaced by new filter
papers. The other filter papers (one per arm) are removed two hours after skin
window formation, for measurements of the acute phase response. The skin window
used for the measurement of baseline situation will also be used (with new
filter papers) for assessment of the late response after 24 hours.
Intervention
na
Study burden and risks
Patients and control subjects will come to the LUMC at two consecutive days.
The first visit will take 2.5 hours, on the second day the visit is only 10
minutes.
Side effects caused by this study are expected to be minimal. Dermal abrasion
can cause redness, swelling and an uncomfortable feeling at the area of the
skin window. Application of LTA or lipid A can cause flare and swelling.
postbus 9600
2300 RC Leiden
Nederland
postbus 9600
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
* Patients should fulfill the criteria for CRPS I according to the clinical diagnostic criteria of the IASP:
o Continuing pain, allodynia or hyperalgesia that is not limited to the territory of a single peripheral nerve and is disproportionate to the inciting event.
o Evidence at some time of edema, changes in skin blood flow or abnormal sudomotoric activity in the region of the pain
o This diagnosis is excluded by the existence of conditions that would otherwise account for the degree of pain and dysfunction. ;* Patients should fulfill the diagnostic criteria for CRPS I according to Veldman:
o Four or five of:
* Unexplained diffuse pain
* Difference in skin color relative to the other limb
* Diffuse edema
* Difference in skin temperature relative to the other limb
* Limited active range of motion
o Occurrence or increase of the above signs and symptoms after use
o The above signs and symptoms are present in an area larger than the area of primary injury or operation and include the area distal to the primary injury. ;* Patients should have one affected and one unaffected arm.
Exclusion criteria
* Patients and controls should have no history of any (other) chronic inflammatory diseases.
* Patients and controls are excluded when immunosuppressive medication is used.
* Patients and controls are excluded when having an infectious disease at the time of the measurements.
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 | NL20217.058.07 |