NCT01618604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

7 months

First QC Date

June 11, 2012

Last Update Submit

December 30, 2012

Conditions

Keywords

Conditioned Pain ModulationQuantitative Sensory Testingdurationcorrelation

Study Arms (1)

Healthy

26 healthy voluntary probands

Procedure: Quantitative Sensory TestingProcedure: Conditioned Pain ModulationProcedure: Repetition of four QST parameters

Interventions

following the standardized protocol of DFNS

Also known as: QST
Healthy

test stimulus by hot thermode conditioned stimulus by cold water bath

Also known as: CPM, DNIC, Diffuse Noxious Inhibitory Controls
Healthy

* warm detection threshold (WDT) * cold detection threshold (CDT) * mechanical detection threshold (MDT) * mechanical pain threshold (MPT)

Also known as: WDT, CDT, MDT, MPT, Quantitative Sensory Testing
Healthy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy voluntary probands

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bergmannsheil, department for pain management

Bochum, North Rhine-Westphalia, 44789, Germany

Location

Related Publications (1)

  • Gehling J, Mainka T, Vollert J, Pogatzki-Zahn EM, Maier C, Enax-Krumova EK. Short-term test-retest-reliability of conditioned pain modulation using the cold-heat-pain method in healthy subjects and its correlation to parameters of standardized quantitative sensory testing. BMC Neurol. 2016 Aug 5;16:125. doi: 10.1186/s12883-016-0650-z.

Study Officials

  • Christoph Maier, Prof. Dr. med

    University hospital Bergmannsheil department of pain management

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Dep. of Pain Management

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations