The primary objective of this study is to compare muscle blood flow and oxygen consumption, as measured by NIRS, in patients with cold type CRPS and healthy controls. The secondary objectives of this study are to compare muscle oxygenation (tissue…
ID
Source
Brief title
Condition
- Other condition
- Tissue disorders NEC
Synonym
Health condition
Skeletspier metabolisme en doorbloeding bij koude complex regionale pijnsyndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters consist of the within person and between person
difference in muscle oxygen consumption and blood flow in patients with cold
type CRPS and controls. These differences are tested during rest and exercise.
Secondary outcome
Secondary study parameters will be:
- The tissue saturation index (TSI) during rest and exercise. This is an
estimate of the tissue oxygen saturation in percentage.
- The rise in oxyhemoglobin during reactive hyperemia. This is measured during
rest and exercise.
Background summary
Complex regional pain syndrome (CRPS) is a clinical disorder characterized by
severe pain in an injured limb which is accompanied by sensory, motor,
vasomotor, trophic and sudomotor changes. A precise pathophysiological
mechanism for CRPS is yet to be revealed. A new hypothesis has been proposed
which suggests that deep tissue (i.e. muscle, bone and nerve) microvascular
injury, inflammation and ischemia might be the driving force for (cutaneous)
findings in CRPS (e.g. allodynia). Based on this theory, the aim of this study
is to examine muscle oxygen consumption and blood flow, using near-infrared
spectroscopy (NIRS), in the skeletal muscles of patients with cold type CRPS as
compared to controls. Cold type CRPS is characterized by bilateral temperature
asymmetry, bilateral perfusion differences and atrophy of skin, muscle and
bone. The results of this study could lead to a better understanding of the
role of deep tissue pathology in cold type CRPS and could have implications for
the diagnoses and management of this syndrome
Study objective
The primary objective of this study is to compare muscle blood flow and oxygen
consumption, as measured by NIRS, in patients with cold type CRPS and healthy
controls. The secondary objectives of this study are to compare muscle
oxygenation (tissue saturation index, %) and reactive hyperaemia rates during
rest and exercise in patients with cold type CRPS and controls.
Study design
This study is a prospective case-control study.
Intervention
Both groups will receive a venous and arterial occlusion during the
measurements to determine the muscle blood flow and oxygen consumption
respectively.
Study burden and risks
The risks of this study are negligible. The NIRS-device is a non-invasive
device which is placed on the skin for the measurements. Arterial occlusions
are sometimes considered painful hence precautions such as shortening the
length of the occlusion and placing the blood pressure cuff outside the painful
area have been taken to avoid any discomfort. The study requires one visit to
the outpatient clinic of the Department of Pain Medicine at Erasmus Medical
Centre. The study visit will take approximately 2 hours and 45 minutes. There
is no direct benefit of participation in this study. This study could lead to a
better understanding of the pathophysiology of CRPS and could pave the way for
new therapies targeting deep tissue pathology.
's Gravendijkwal 230
Rotterdam 3000CA
NL
's Gravendijkwal 230
Rotterdam 3000CA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients with the diagnosis cold unilateral CRPS of an upper or lower limb according to the Budapest Research Criteria (not applicable in Controls):
Continuing pain, which is disproportionate to any inciting event
Must report at least one symptom in three of the four following categories:
Sensory: reports of hyperesthesia and/or allodynia
Vasomotor: reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry
Sudomotor/edema: reports of edema and/or seating changes and/or sweating asymmetry
Motor/trophic: reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
Must display at least one sign at time of evaluation in two or more of the following categories:
Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement)
Vasomotor: evidence of temperature asymmetry with the affected side being >= 1° colder than the unaffected side.
Sudomotor/edema: evidence of edema and/or sweating changes and/or sweating asymmetry
Motor/trophic: evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
There is no other diagnosis that better explains the signs and symptoms.
- Age >= 18 years
- Able to provide written informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Known history of peripheral arterial disease (PAD) or suspicion of PAD at intake
- Known history of Diabetes Mellitus
- Other confounding neuropathic conditions i.e. paraplegia and neuropathies due to other causes than CRPS.
- Coagulopathy or use of blood thinners
- Use of vasoactive medications
- Pregnancy
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 | NL54178.078.15 |