Ignite Creation Date:
2024-05-06 @ 12:36 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01618604
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2012-06-11
Brief Title:
QST in Context With Conditioned Pain Modulation
Sponsor:
Ruhr University of Bochum
Organization:
Ruhr University of Bochum
Study Overview
Official Title:
Quantitative Sensory Testing in Context With Conditioned Pain Modulation CPM
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPM
Brief Summary:
Conditioned Pain Modulation CPM is a phenomenon which isnt examined enough Many factors of influence such as gender age and psyche are already known - but the duration of such effects their reliability and the correlation between standardized Quantitative Sensory Testing QST and CPM is still unknown
In this study the investigators expect to find parameters in QST that correlate with the efficacy of Conditioned Pain Modulation Knowing factors that indicate high or low potential CPM could help finding patients-at-risk and adapting their therapy
In this study the investigators expect to find parameters in QST that correlate with the efficacy of Conditioned Pain Modulation Knowing factors that indicate high or low potential CPM could help finding patients-at-risk and adapting their therapy
Detailed Description:
Conditioned Pain Modulation was firstly found in rats by electrical stimulation of their spinal cord and called Diffuse Noxious Inhibitory Controls In humans such experimental settings are impossible That is why we need two noxious stimuli for provoking such an endogenous pain inhibition
Before the CPM setting begins we will investigate our 32 healthy probands by basic QST following the protocol of DFNS German Research Network on Neuropathic Pain This assessment helps us to create a sensory profile for every proband and to look for correlations between QST parameters and CPM efficacy Then the CPM setting follows In our experimental design we use a test stimulus TS on the dominant forearm by thermode normally 45-47C depending on the pain rating we need scores NRS 60 and a conditioned stimulus CS on the other hand by cold water bath 10C Both stimuli must be rated on the numerical rating scale NRS 0-100 alone and in combination A positive effect can be seen if the difference between TS alone and TS in combination with CS is 0 To learn more about the duration of CPM effects we decided to repeat four QST parameters cold detection threshold warm detection threshold mechanical detection threshold and mechanical pain threshold within 30 minutes after finishing the CPM part to detect changes of time
The whole study design will be repeated 24-72h hours later to increase the test-retest-reliability
Before the CPM setting begins we will investigate our 32 healthy probands by basic QST following the protocol of DFNS German Research Network on Neuropathic Pain This assessment helps us to create a sensory profile for every proband and to look for correlations between QST parameters and CPM efficacy Then the CPM setting follows In our experimental design we use a test stimulus TS on the dominant forearm by thermode normally 45-47C depending on the pain rating we need scores NRS 60 and a conditioned stimulus CS on the other hand by cold water bath 10C Both stimuli must be rated on the numerical rating scale NRS 0-100 alone and in combination A positive effect can be seen if the difference between TS alone and TS in combination with CS is 0 To learn more about the duration of CPM effects we decided to repeat four QST parameters cold detection threshold warm detection threshold mechanical detection threshold and mechanical pain threshold within 30 minutes after finishing the CPM part to detect changes of time
The whole study design will be repeated 24-72h hours later to increase the test-retest-reliability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None