Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-28 @ 11:24 AM
Study NCT ID:
NCT01618604
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2012-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QST in Context With Conditioned Pain Modulation
Sponsor:
Ruhr University of Bochum
Organization:
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 isn't 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 45-47°C, depending on the pain rating, we need scores \>NRS 60) and a conditioned stimulus (CS) on the other hand by cold water bath (10°C). 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 45-47°C, depending on the pain rating, we need scores \>NRS 60) and a conditioned stimulus (CS) on the other hand by cold water bath (10°C). 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:
False
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?: