The aim is to investigate static and dynamic tissue oxygenation state and skin temperature in patients with CRPS-I and to compare CRPS-I patients with pain patients and healthy controls. The correlation between tissue oxygenation, skin temperature…
ID
Source
Brief title
Condition
- Other condition
- Peripheral neuropathies
Synonym
Health condition
Complex Regionaal Pijn Syndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tissue oxygenation in both static and dynamic conditions will be compared
between CRPS-affected and unaffected limbs and between CRPS patients, pain
controls and healthy controls. Furthermore, differences in tissue oxygenation
in static and dynamic measurements and correlations with pain, skin temperature
variations, and disease duration will be determined.
Secondary outcome
The correlation between oxygenation and skin temperature with experienced pain,
amount of limb movement, and disease duration will be investigated as well.
Background summary
Pathophysiologic mechanisms of CRPS are not well understood, but vasomotor
disturbances are likely to play a role in initiating and maintaining the
disease. Research indicates that tissue perfusion and oxygenation might have a
causative effect on CRPS; however, whether this is true and to what extent is
yet to be determined.
Study objective
The aim is to investigate static and dynamic tissue oxygenation state and skin
temperature in patients with CRPS-I and to compare CRPS-I patients with pain
patients and healthy controls. The correlation between tissue oxygenation, skin
temperature variation and pain is also investigated.
Study design
This pilot study takes the form of an open prospective and case control study.
Intervention
Oxygen is applied as an intervention to examine and compare its effect on the
oxygenation in healthy participants and CRPS patients.
Study burden and risks
Participants are required to visit the VUmc twice. The first meeting,
questionnaires are filled in, and baseline measurements of tissue oxygenation
and skin temperature are made. The second meeting, follow-up measurements of
both are made. In between the two meetings, participants have to wear small
thermoregistration buttons and keep diaries regarding pain and use of the
buttons. Participation takes approximately seven days, and each meeting is
estimated to take 1-1.5 hours. Risks of the study are minimal, as participants
are only breathing oxygen during tissue oxygenation measurements which carries
negligible risks. Patients do not benefit from participating; however, this
study is expected to result in additional knowledge regarding their disease.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria CRPS-I patients:
CRPS-I according to 2012 IASP (Budapest) criteria: Harden RN, Bruehl S, Perez RS, et al. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain 2010; 150: 268-274.;Inclusion criteria pain controls:
Patients diagnosed with Radiculopathy with pain in one extremity as main symptom;Inclusion criteria healthy controls: >18 years old, healthy (no neurological, cardiac, pulmonary, renal or vascular diseases diagnosed)
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:;- Age <18
- Not able to give informed consent
- Pregnancy
- History of peripheral vascular disease requiring angioplasty or bypass surgery [5]
- Type 1 or 2 diabetes [5]
- History of systemic vasculitis [5]
- Use of vasoactive medication [5]
[5]: Bellingham GA, Smith RS, Morley-Forster P and Murkin JM. Use of near infrared spectroscopy to detect impaired tissue oxygen saturation in patients with complex regional pain syndrome type 1. Can J Anaesth 2014; 61: 563-570.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2016-001353-41-NL |
| CCMO | NL56714.029.16 |