HealthyCPMNCT01618604
QST in Context With Conditioned Pain Modulation
An observational study of Healthy, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Quantitative Sensory Testing, Conditioned Pain Modulation and Repetition of four QST parameters
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy voluntary probands
Who may be able to join
- healthy probands >18 years
- right-handedness
- informed consent
- no chronic pain
- no drugs (but oral contraceptives)
- no neurological diseases
- no psychiatric diseases
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Bergmannsheil, department for pain management
Bochum, North Rhine-Westphalia, 44789
About this study
Official title: Quantitative Sensory Testing in Context With Conditioned Pain Modulation (CPM)
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.
Read the 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
- Being tested
- Quantitative Sensory Testing, Conditioned Pain Modulation, Repetition of four QST parameters
- Keywords
- Conditioned Pain Modulation, Quantitative Sensory Testing, duration, correlation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory TestingProcedure or surgery
Also called QST
following the standardized protocol of DFNS
Conditioned Pain ModulationProcedure or surgery
Also called CPM, DNIC, Diffuse Noxious Inhibitory Controls
test stimulus by hot thermode conditioned stimulus by cold water bath
Repetition of four QST parametersProcedure or surgery
Also called WDT, CDT, MDT, MPT
- warm detection threshold (WDT)
- cold detection threshold (CDT)
- mechanical detection threshold (MDT)
- mechanical pain threshold (MPT)
| Study group | Role | What they receive |
|---|---|---|
| Healthy | 26 healthy voluntary probands Receives: Procedure: Quantitative Sensory Testing; Procedure: Conditioned Pain Modulation; Procedure: Repetition of four QST parameters |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
- Investigators
- Christoph Maier, Prof. Dr. med, Study director, University hospital Bergmannsheil department of pain management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618604
- Sponsor's protocol ID
- CPM2012
- Acronym
- CPM
- Status last verified
- Dec 2012
- First submitted
- 11 Jun 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27495743
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Testing in Context With Conditioned Pain Modulation (CPM)
- ClinicalTrials.gov ID
- NCT01618604
- Acronym / sponsor ID
- CPM / CPM2012
- Conditions
- Healthy
- Keywords
- Conditioned Pain Modulation, Quantitative Sensory Testing, duration, correlation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Procedure: Quantitative Sensory Testing, Procedure: Conditioned Pain Modulation, Procedure: Repetition of four QST parameters26 healthy voluntary probands |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy voluntary probands
Key inclusion criteria (7 listed)
- healthy probands >18 years
- right-handedness
- informed consent
- no chronic pain
- no drugs (but oral contraceptives)
Key exclusion criteria (8 listed)
- no informed consent
- language deficits
- left-handedness
- not enough pain intensity by thermode or cold water bath
- psychiatric disease, neurological diseases other chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Sensory TestingAlso: QSTfollowing the standardized protocol of DFNS | Procedure or surgery | Healthy |
| Conditioned Pain ModulationAlso: CPM, DNIC, Diffuse Noxious Inhibitory Controlstest stimulus by hot thermode conditioned stimulus by cold water bath | Procedure or surgery | Healthy |
| Repetition of four QST parametersAlso: WDT, CDT, MDT, MPT* warm detection threshold (WDT) * cold detection threshold (CDT) * mechanical detection threshold (MDT) * mechanical pain threshold (MPT) | Procedure or surgery | Healthy |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Derived from this study: PubMed 27495743Gehling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Maier, Prof. Dr. med study director
University hospital Bergmannsheil department of pain management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01618604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.