To explore the factors that contribute to CPM variability we will conduct various CPM protocols in healthy volunteers. The study will include two protocols, a standard protocol common to all sites, and a second protocol, the *home protocol* used at…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening, onderzoek naar endogene pijnstilling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Explore the factors that contribute to CPM variability in order to optimize
testing protocols and minimize variability
Secondary outcome
na
Background summary
Conditioned pain modulation (CPM) is an experimental test to evaluate the
endogenous pain modulatory system. It consists of a painful test stimulus
(mostly heat pain on the lower arm) and a conditioning stimulus on a remote
area which is able to facilitate or inhibit the pain of the test stimulus.
CPM protocols differ across research sites all over the world which makes
comparison between studies hard. Data regarding the influence of the variation
in protocols on CPM outcome is lacking.
Study objective
To explore the factors that contribute to CPM variability we will conduct
various CPM protocols in healthy volunteers. The study will include two
protocols, a standard protocol common to all sites, and a second protocol, the
*home protocol* used at each specific site.
Next, all data will be collected from the various sites. Data from the standard
protocol will be used to analyze variation between sites, and it*s possible
contributing factors. The second protocol will serve to identify the influence
of specific deviations from the standard protocol (e.g. testing modalities,
body sites etc.), and develop correction factors for these parameters that will
allow comparison of results from the various protocols used. The LUMC will only
perform the CPM tests, the statistical analysis will be performed elsewhere.
Study design
The study is an experimental validation study to explore factors that
contribute to CPM variability in order to optimize testing protocols and
minimize variability. The subjects in the study will attend one session in
which two CPM protocols will be tested. The standard protocol will be performed
randomized to the 'home protocol'. Between the two, a break of 30 minutes is
incorporated. The total protocol will take about 3 hours to complete. The study
will be performed in the anesthesiology research facility
Intervention
CPM tests - a method to quantify endogenous pain modulation
Study burden and risks
Study duration is 3 hours, in which the volunteers will receive several pain
tests. These tests are safe and can induce shortlasting itch or redness of the
tested skin. There are negligible risks. The burden is limited; it is a single
visit.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
-Healthy according to medical history, physical examination and vital signs;
-Age 18-40;
-Able to give informed consent;
Exclusion criteria
-Presence of health issues including clinical pain of any kind in the previous
3 months;
-Use of continuous pain medication;
-Pregnancy or lactation;
-Participation in another study at the same time;
-Presence of in dept knowledge or experience of/in CPM testing or CPM study
methods
Design
Recruitment
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 | NL74710.058.20 |