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QST in Context With Conditioned Pain Modulation (CPM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01618604
First received: June 11, 2012
Last updated: December 30, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Healthy
Procedure: Quantitative Sensory Testing
Procedure: Conditioned Pain Modulation
Procedure: Repetition of four QST parameters

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantitative Sensory Testing in Context With Conditioned Pain Modulation (CPM)

Further study details as provided by Ruhr University of Bochum:

Enrollment: 26
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy
26 healthy voluntary probands
Procedure: Quantitative Sensory Testing
following the standardized protocol of DFNS
Other Name: QST
Procedure: Conditioned Pain Modulation
test stimulus by hot thermode conditioned stimulus by cold water bath
Other Names:
  • CPM
  • DNIC
  • Diffuse Noxious Inhibitory Controls
Procedure: Repetition of four QST parameters
  • warm detection threshold (WDT)
  • cold detection threshold (CDT)
  • mechanical detection threshold (MDT)
  • mechanical pain threshold (MPT)
Other Names:
  • WDT
  • CDT
  • MDT
  • MPT
  • Quantitative Sensory Testing

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy voluntary probands

Criteria

Inclusion Criteria:

  • healthy probands >18 years
  • right-handedness
  • informed consent
  • no chronic pain
  • no drugs (but oral contraceptives)
  • no neurological diseases
  • no psychiatric diseases

Exclusion Criteria:

  • no informed consent
  • language deficits
  • left-handedness
  • not enough pain intensity by thermode or cold water bath
  • psychiatric disease, neurological diseases other chronic disease
  • chronic pain syndromes
  • pregnancy or lactation
  • permanent drug use, drug use in the last 14 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618604

Locations
Germany
Bergmannsheil, department for pain management
Bochum, Nordrhein-Westfalen, Germany, 44789
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Study Director: Christoph Maier, Prof. Dr. med University hospital Bergmannsheil department of pain management
  More Information

No publications provided

Responsible Party: Christoph Maier, Prof. Dr., Head of the Dep. of Pain Management, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01618604     History of Changes
Other Study ID Numbers: CPM2012
Study First Received: June 11, 2012
Last Updated: December 30, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
Conditioned Pain Modulation
Quantitative Sensory Testing
duration
correlation

ClinicalTrials.gov processed this record on November 25, 2014