QST in Context With Conditioned Pain Modulation

NCT ID: NCT01618604

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Healthy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy

26 healthy voluntary probands

Quantitative Sensory Testing

Intervention Type: PROCEDURE

following the standardized protocol of DFNS

Conditioned Pain Modulation

Intervention Type: PROCEDURE

test stimulus by hot thermode conditioned stimulus by cold water bath

Repetition of four QST parameters

Intervention Type: PROCEDURE

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

Interventions

Quantitative Sensory Testing

following the standardized protocol of DFNS

Intervention Type: PROCEDURE

Conditioned Pain Modulation

test stimulus by hot thermode conditioned stimulus by cold water bath

Intervention Type: PROCEDURE

Repetition of four QST parameters

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

Intervention Type: PROCEDURE

Other Intervention Names

QST; CPM; DNIC; Diffuse Noxious Inhibitory Controls; WDT; CDT; MDT; MPT; Quantitative Sensory Testing

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Christoph Maier, Prof. Dr.

Head of the Dep. of Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Maier, Prof. Dr. med

Role: STUDY_DIRECTOR

University hospital Bergmannsheil department of pain management

Locations

Bergmannsheil, department for pain management

Bochum, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 27495743 (View on PubMed)

Other Identifiers

CPM2012

Identifier Type: -

Identifier Source: org_study_id