PainCPM_AWARENCT05161286
The Influence of Expectations, Attention and the Test Paradigm on the Efficacy of the Pain Processing System
An observational study of Pain, run by University Ghent at 1 site in Belgium.
Trial summary
Conditioned pain modulation (CPM) is the endogenous pain relief mechanism responsible for the "pain-inhibits-pain" phenomenon. This mechanism can be activated experimentally, and its efficiency evaluated by experimental pain tests. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Aug 2021to 1 Dec 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy pain-free Dutch-speaking men and women between the age of 18 and 65 years. Participants will be recruited amongst friends, relatives and fellow students of the researchers.
Who may be able to join
- Dutch speaking participants (age between 18 and 65 years)
- Healthy volunteers who have no pain complaints
Who cannot join
- Not speaking Dutch
- A history of serious health issues (e.g. cancer, stroke, epilepsy, diabetes, depression, etc...)
- History of pain complaints or current pain (e.g. people who suffer from severe migraine, low back pain, neck pain, frozen shoulder, meniscectomy,...)
- Cognitive, arithmetic or attention disorders
- Pregnancy or breastfeeding in the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Expectations, Attention and Test Paradigm on the Efficacy of the Pain Processing System
Conditioned pain modulation (CPM) is the endogenous pain relief mechanism responsible for the "pain-inhibits-pain" phenomenon. This mechanism can be activated experimentally, and its efficiency evaluated by experimental pain tests. According to the "pain-inhibits-pain" principle, during such an experimental testing paradigm, a painful test stimulus is typically applied, followed by a conditioning stimulus. The effect of the conditioning stimulus on the test stimulus is examined to determine whether or not the conditioning stimulus elicits an inhibitory effect. With this study, the investigators want to examine in pain-free adults whether and to what extend the efficacy of CPM is influenced by 1) attention (focus versus distraction), 2) intrinsic expectations (pain reduction versus no change versus pain increase) with regard to pain due to the CPM paradigm used, and 3) the order of application of the test stimulus and conditioning stimulus (sequential versus parallel paradigm).
Read the detailed description
Despite the widespread use of CPM by researchers, there is still no gold standard for conducting this test. Both a sequential and a parallel application of the test stimulus and the conditioning stimulus are often used interchangeably and side by side. In both paradigms, the pain intensity or pain threshold of the test stimulus is first determined. Subsequently, in the parallel protocol, the test stimulus is reapplied while simultaneously applying the conditioning stimulus. In the sequential protocol, the conditioning stimulus is applied first, and after removing the latter stimulus, the test stimulus is reapplied (the CPM effect is visible up to 5 minutes after removal of the conditioning stimulus). The difference between the initial and repeated test stimulus (during or after conditioning) is quantified to express the CPM effect.
Even the publication of an expert opinion, which decided in favor of the sequential paradigm, has so far changed little in the use of the two paradigms. In that same publication, international CPM experts considered the sequential order 'purer' than the parallel order, as the results of the latter can be attributed to a shift of attention to the conditioning stimulus. However, this claim has little support from the literature. Some researchers even argue that cognitive mechanisms such as attentional shift might be part of the underlying mechanism of the CPM effect. Existing research also shows that CPM effectiveness is influenced by expectations. For this, previous studies conditioned test subjects by telling them in advance that the conditioning stimulus would reduce or increase pain. However, when the experimental CPM paradigm is used to investigate the effectiveness of the pain-inhibiting system, no such suggestions are made. However, this does not preclude that when the test protocol is explained to the subject, he or she does not create intrinsic expectations regarding the pain that is provoked. However, few studies have investigated this and the results of these studies are inconsistent and therefore do not allow conclusions to be drawn.
The aim of this study is to compare a sequential protocol with a parallel protocol on the one hand, and to measure the influence of expectations, attention and distraction on the CPM effect on the other.
In this study, the test stimulus of the CPM measurement will consist of a mechanical stimulus applied with an analog algometer (Force Dial model FDK 10 and 40 Push Pull Force Gage, Wagner instruments, Greenwich, Connecticut) on the Brachioradialis and Quadriceps muscle of the dominant side. The pressure pain threshold will be determined and used as an outcome measure. The conditioning stimulus consists of immersing the hand (up to 10 cm above the wrist) of the non-dominant side in warm water at a temperature of 45,5°C for 6 minutes. This temperature has been proven to be a reliable stimulus, eliciting solid effects.
At the time of testing, the CPM measurement will therefore be performed four times, each time with a small variation. The order of the variations is determined at random. There is a break of 10 minutes between each performance, so that the effect of the previous performance has worn off. The four variations of the CPM paradigm are the following:
- Sequential protocol: the test stimulus is applied before and after the conditioning stimulus
- Parallel protocol: the test stimulus is applied before, after and during immersion (at minute 4)
- Focus protocol: this protocol works like the sequential protocol. In addition, the subject will be asked to give a pain score from 0 (no pain) to 100 (excruciating pain) every 30 seconds during immersion, thereby focusing on the conditioning stimulus.
- Distraction protocol: this protocol works like the sequential protocol. During the immersion, attention will be diverted away from the conditioning stimulus by having the subject perform a cognitive test known as the Paced Auditory Serial Addition Test (PASAT). The latter implies that the subject must listen to an auditory series of numbers, memorize them and add them.
Before the actual test begins, a familiarization moment will take place, in which the subject becomes acquainted with the test and the conditioning stimulus by undergoing it for the first time. There will also be a practice session of the PASAT at that time.
Before the start of the CPM test, two questionnaires are taken: a general questionnaire assessing sociodemographic and health-related characteristics, and the Hospital Anxiety and Depression Scale (HADS), which provides an indication of feelings of anxiety and depression that the subject might experience, as such factors may have an influence (i.e. known confounders) on the CPM effect.
Finally, for each variation on the CPM paradigm, it will be briefly explained what the protocol to be undergone entails. This involves assessing the subject's expectations with regard to the related protocol. The subject will have to indicate whether he / she expects the immersion to have an influence on the pressure threshold measurement (yes, pain increase; yes, pain reduction; no, no effect). If the participants answer "yes", the subjects are asked to quantify the expected impact by indicating how much more or less pressure is expected to be tolerated (in percentages).
This study has a cross-sectional design and the familiarization and the experimental CPM assessments take place during during a single test session of about 2 hours.
- Conditions
- Pain
- Keywords
- endogenous pain modulation, conditioned pain modulation, expectations, attention, test paradigm
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy pain-free cohort | Healthy pain-free Dutch-speaking men and women between the age of 18 and 65 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned pain modulation (CPM) magnitude (kg/cm²)
CPM magnitude is evaluated during 4 different CPM test protocols (sequential, focus, distraction, parallel) and will be compared between these protocols to answer the research questions. The test stimulus (i.e. mean mechanical pain pressure threshold measured at the Brachioradialis and Quadriceps muscle of the dominant side expressed in kg/cm²) is assessed before the application (minute 0) of the conditioning stimulus (i.e. hot thermal water immersion of the hand), and once again at minute 4 during conditioning stimulation (parallel protocol) or at 6 minutes 30 seconds which is 30 seconds after removal of the conditioning stimulus (sequential, focus and distraction protocol). CPM (kg/cm²) magnitude is calculated by subtracting the first test stimulus from the second test stimulus assessment, with a negative CPM value (kg/cm²) denoting pain inhibition, and a positive CPM (kg/cm²) value denoting pain facilitation.
Measured: cross-sectional (single test session, day 0)
Secondary outcomes (2)
Sociodemographic and health-related characteristics
A general questionnaire assessing sociodemographic and health related characteristics
Measured: cross-sectional (single test session, day 0)
Hospital Anxiety and Depression Scale (HADS)
A questionnaire assessing anxiety and depression;
A score on the subscale of: 0-7 (no anxiety disorder or depression), 8-10 (a possible anxiety disorder or depression), 11-21 (a suspected anxiety disorder or depression)
Measured: cross-sectional (single test session, day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start12 Aug 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Van Oosterwijck, Prof, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161286
- Sponsor's protocol ID
- BC-08516
- Acronym
- CPM_AWARE
- Status last verified
- Feb 2021
- First submitted
- 12 Aug 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20.
PubMed 25330039Goffaux P, Redmond WJ, Rainville P, Marchand S. Descending analgesia--when the spine echoes what the brain expects. Pain. 2007 Jul;130(1-2):137-43. doi: 10.1016/j.pain.2006.11.011. Epub 2007 Jan 9.
PubMed 17215080Bjorkedal E, Flaten MA. Expectations of increased and decreased pain explain the effect of conditioned pain modulation in females. J Pain Res. 2012;5:289-300. doi: 10.2147/JPR.S33559. Epub 2012 Aug 17.
PubMed 23049277Lewis GN, Leys A, Rice DA, McNair PJ. Subconscious manipulation of pain expectation can modulate cortical nociceptive processing. Pain Pract. 2015 Feb;15(2):117-23. doi: 10.1111/papr.12157. Epub 2013 Dec 11.
PubMed 24325269Cormier S, Piche M, Rainville P. Expectations modulate heterotopic noxious counter-stimulation analgesia. J Pain. 2013 Feb;14(2):114-25. doi: 10.1016/j.jpain.2012.10.006. Epub 2012 Dec 20.
PubMed 23260452France CR, Burns JW, Gupta RK, Buvanendran A, Chont M, Schuster E, Orlowska D, Bruehl S. Expectancy Effects on Conditioned Pain Modulation Are Not Influenced by Naloxone or Morphine. Ann Behav Med. 2016 Aug;50(4):497-505. doi: 10.1007/s12160-016-9775-y.
PubMed 26809850Kennedy DL, Kemp HI, Ridout D, Yarnitsky D, Rice ASC. Reliability of conditioned pain modulation: a systematic review. Pain. 2016 Nov;157(11):2410-2419. doi: 10.1097/j.pain.0000000000000689.
PubMed 27559835Nir RR, Granovsky Y, Yarnitsky D, Sprecher E, Granot M. A psychophysical study of endogenous analgesia: the role of the conditioning pain in the induction and magnitude of conditioned pain modulation. Eur J Pain. 2011 May;15(5):491-7. doi: 10.1016/j.ejpain.2010.10.001. Epub 2010 Oct 28.
PubMed 21035364Nir RR, Yarnitsky D, Honigman L, Granot M. Cognitive manipulation targeted at decreasing the conditioning pain perception reduces the efficacy of conditioned pain modulation. Pain. 2012 Jan;153(1):170-176. doi: 10.1016/j.pain.2011.10.010. Epub 2011 Nov 25.
PubMed 22119318Reinert A, Treede R, Bromm B. The pain inhibiting pain effect: an electrophysiological study in humans. Brain Res. 2000 Apr 17;862(1-2):103-10. doi: 10.1016/s0006-8993(00)02077-1.
PubMed 10799674Gronwall DM. Paced auditory serial-addition task: a measure of recovery from concussion. Percept Mot Skills. 1977 Apr;44(2):367-73. doi: 10.2466/pms.1977.44.2.367.
PubMed 866038Rao SM, Leo GJ, Haughton VM, St Aubin-Faubert P, Bernardin L. Correlation of magnetic resonance imaging with neuropsychological testing in multiple sclerosis. Neurology. 1989 Feb;39(2 Pt 1):161-6. doi: 10.1212/wnl.39.2.161.
PubMed 2915783Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.
PubMed 2027484Billens A, Dhondt E, Dierickx E, Van Damme S, De Greef I, Van Oosterwijck S, Meeus M, Van Oosterwijck J. Attentional Focus but Not Distraction or Expectations Influence Conditioned Pain Modulation in Healthy Adults. Eur J Pain. 2025 Jul;29(6):e70058. doi: 10.1002/ejp.70058.
PubMed 40542602
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Expectations, Attention and Test Paradigm on the Efficacy of the Pain Processing System
- ClinicalTrials.gov ID
- NCT05161286
- Acronym / sponsor ID
- CPM_AWARE / BC-08516
- Conditions
- Pain
- Keywords
- endogenous pain modulation, conditioned pain modulation, expectations, attention, test paradigm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 17 Dec 2021 (actual)
- 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 the endogenous pain relief mechanism responsible for the "pain-inhibits-pain" phenomenon. This mechanism can be activated experimentally, and its efficiency evaluated by experimental pain tests. According to the "pain-inhibits-pain" principle, during such an experimental testing paradigm, a painful test stimulus is typically applied, followed by a conditioning stimulus. The effect of the conditioning stimulus on the test stimulus is examined to determine whether or not the conditioning stimulus elicits an inhibitory effect. With this study, the investigators want to examine in pain-free adults whether and to what extend the efficacy of CPM is influenced by 1) attention (focus versus distraction), 2) intrinsic expectations (pain reduction versus no change versus pain increase) with regard to pain due to the CPM paradigm used, and 3) the order of application of the test stimulus and conditioning stimulus (sequential versus parallel paradigm).
Detailed description
Despite the widespread use of CPM by researchers, there is still no gold standard for conducting this test. Both a sequential and a parallel application of the test stimulus and the conditioning stimulus are often used interchangeably and side by side. In both paradigms, the pain intensity or pain threshold of the test stimulus is first determined. Subsequently, in the parallel protocol, the test stimulus is reapplied while simultaneously applying the conditioning stimulus. In the sequential protocol, the conditioning stimulus is applied first, and after removing the latter stimulus, the test stimulus is reapplied (the CPM effect is visible up to 5 minutes after removal of the conditioning stimulus). The difference between the initial and repeated test stimulus (during or after conditioning) is quantified to express the CPM effect.
Even the publication of an expert opinion, which decided in favor of the sequential paradigm, has so far changed little in the use of the two paradigms. In that same publication, international CPM experts considered the sequential order 'purer' than the parallel order, as the results of the latter can be attributed to a shift of attention to the conditioning stimulus. However, this claim has little support from the literature. Some researchers even argue that cognitive mechanisms such as attentional shift might be part of the underlying mechanism of the CPM effect. Existing research also shows that CPM effectiveness is influenced by expectations. For this, previous studies conditioned test subjects by telling them in advance that the conditioning stimulus would reduce or increase pain. However, when the experimental CPM paradigm is used to investigate the effectiveness of the pain-inhibiting system, no such suggestions are made. However, this does not preclude that when the test protocol is explained to the subject, he or she does not create intrinsic expectations regarding the pain that is provoked. However, few studies have investigated this and the results of these studies are inconsistent and therefore do not allow conclusions to be drawn.
The aim of this study is to compare a sequential protocol with a parallel protocol on the one hand, and to measure the influence of expectations, attention and distraction on the CPM effect on the other.
In this study, the test stimulus of the CPM measurement will consist of a mechanical stimulus applied with an analog algometer (Force Dial model FDK 10 and 40 Push Pull Force Gage, Wagner instruments, Greenwich, Connecticut) on the Brachioradialis and Quadriceps muscle of the dominant side. The pressure pain threshold will be determined and used as an outcome measure. The conditioning stimulus consists of immersing the hand (up to 10 cm above the wrist) of the non-dominant side in warm water at a temperature of 45,5°C for 6 minutes. This temperature has been proven to be a reliable stimulus, eliciting solid effects.
At the time of testing, the CPM measurement will therefore be performed four times, each time with a small variation. The order of the variations is determined at random. There is a break of 10 minutes between each performance, so that the effect of the previous performance has worn off. The four variations of the CPM paradigm are the following:
- Sequential protocol: the test stimulus is applied before and after the conditioning stimulus
- Parallel protocol: the test stimulus is applied before, after and during immersion (at minute 4)
- Focus protocol: this protocol works like the sequential protocol. In addition, the subject will be asked to give a pain score from 0 (no pain) to 100 (excruciating pain) every 30 seconds during immersion, thereby focusing on the conditioning stimulus.
- Distraction protocol: this protocol works like the sequential protocol. During the immersion, attention will be diverted away from the conditioning stimulus by having the subject perform a cognitive test known as the Paced Auditory Serial Addition Test (PASAT). The latter implies that the subject must listen to an auditory series of numbers, memorize them and add them.
Before the actual test begins, a familiarization moment will take place, in which the subject becomes acquainted with the test and the conditioning stimulus by undergoing it for the first time. There will also be a practice session of the PASAT at that time.
Before the start of the CPM test, two questionnaires are taken: a general questionnaire assessing sociodemographic and health-related characteristics, and the Hospital Anxiety and Depression Scale (HADS), which provides an indication of feelings of anxiety and depression that the subject might experience, as such factors may have an influence (i.e. known confounders) on the CPM effect.
Finally, for each variation on the CPM paradigm, it will be briefly explained what the protocol to be undergone entails. This involves assessing the subject's expectations with regard to the related protocol. The subject will have to indicate whether he / she expects the immersion to have an influence on the pressure threshold measurement (yes, pain increase; yes, pain reduction; no, no effect). If the participants answer "yes", the subjects are asked to quantify the expected impact by indicating how much more or less pressure is expected to be tolerated (in percentages).
This study has a cross-sectional design and the familiarization and the experimental CPM assessments take place during during a single test session of about 2 hours.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy pain-free cohort | – | –Healthy pain-free Dutch-speaking men and women between the age of 18 and 65 years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy pain-free Dutch-speaking men and women between the age of 18 and 65 years. Participants will be recruited amongst friends, relatives and fellow students of the researchers.
Key inclusion criteria (2 listed)
- Dutch speaking participants (age between 18 and 65 years)
- Healthy volunteers who have no pain complaints
Key exclusion criteria (5 listed)
- Not speaking Dutch
- A history of serious health issues (e.g. cancer, stroke, epilepsy, diabetes, depression, etc...)
- History of pain complaints or current pain (e.g. people who suffer from severe migraine, low back pain, neck pain, frozen shoulder, meniscectomy,...)
- Cognitive, arithmetic or attention disorders
- Pregnancy or breastfeeding in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Conditioned pain modulation (CPM) magnitude (kg/cm²)
Time frame: cross-sectional (single test session, day 0)
CPM magnitude is evaluated during 4 different CPM test protocols (sequential, focus, distraction, parallel) and will be compared between these protocols to answer the research questions. The test stimulus (i.e. mean mechanical pain pressure threshold measured at the Brachioradialis and Quadriceps muscle of the dominant side expressed in kg/cm²) is assessed before the application (minute 0) of the conditioning stimulus (i.e. hot thermal water immersion of the hand), and once again at minute 4 during conditioning stimulation (parallel protocol) or at 6 minutes 30 seconds which is 30 seconds after removal of the conditioning stimulus (sequential, focus and distraction protocol). CPM (kg/cm²) magnitude is calculated by subtracting the first test stimulus from the second test stimulus assessment, with a negative CPM value (kg/cm²) denoting pain inhibition, and a positive CPM (kg/cm²) value denoting pain facilitation.
2 secondary outcomes
Sociodemographic and health-related characteristics
Time frame: cross-sectional (single test session, day 0)
Hospital Anxiety and Depression Scale (HADS)
Time frame: cross-sectional (single test session, day 0)
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 8 Apr 2022.
- Background: PubMed 25330039Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20.
- Background: PubMed 17215080Goffaux P, Redmond WJ, Rainville P, Marchand S. Descending analgesia--when the spine echoes what the brain expects. Pain. 2007 Jul;130(1-2):137-43. doi: 10.1016/j.pain.2006.11.011. Epub 2007 Jan 9.
- Background: PubMed 23049277Bjorkedal E, Flaten MA. Expectations of increased and decreased pain explain the effect of conditioned pain modulation in females. J Pain Res. 2012;5:289-300. doi: 10.2147/JPR.S33559. Epub 2012 Aug 17.
- Background: PubMed 24325269Lewis GN, Leys A, Rice DA, McNair PJ. Subconscious manipulation of pain expectation can modulate cortical nociceptive processing. Pain Pract. 2015 Feb;15(2):117-23. doi: 10.1111/papr.12157. Epub 2013 Dec 11.
- Background: PubMed 23260452Cormier S, Piche M, Rainville P. Expectations modulate heterotopic noxious counter-stimulation analgesia. J Pain. 2013 Feb;14(2):114-25. doi: 10.1016/j.jpain.2012.10.006. Epub 2012 Dec 20.
- Background: PubMed 26809850France CR, Burns JW, Gupta RK, Buvanendran A, Chont M, Schuster E, Orlowska D, Bruehl S. Expectancy Effects on Conditioned Pain Modulation Are Not Influenced by Naloxone or Morphine. Ann Behav Med. 2016 Aug;50(4):497-505. doi: 10.1007/s12160-016-9775-y.
- Background: PubMed 27559835Kennedy DL, Kemp HI, Ridout D, Yarnitsky D, Rice ASC. Reliability of conditioned pain modulation: a systematic review. Pain. 2016 Nov;157(11):2410-2419. doi: 10.1097/j.pain.0000000000000689.
- Background: PubMed 21035364Nir RR, Granovsky Y, Yarnitsky D, Sprecher E, Granot M. A psychophysical study of endogenous analgesia: the role of the conditioning pain in the induction and magnitude of conditioned pain modulation. Eur J Pain. 2011 May;15(5):491-7. doi: 10.1016/j.ejpain.2010.10.001. Epub 2010 Oct 28.
- Background: PubMed 22119318Nir RR, Yarnitsky D, Honigman L, Granot M. Cognitive manipulation targeted at decreasing the conditioning pain perception reduces the efficacy of conditioned pain modulation. Pain. 2012 Jan;153(1):170-176. doi: 10.1016/j.pain.2011.10.010. Epub 2011 Nov 25.
- Background: PubMed 10799674Reinert A, Treede R, Bromm B. The pain inhibiting pain effect: an electrophysiological study in humans. Brain Res. 2000 Apr 17;862(1-2):103-10. doi: 10.1016/s0006-8993(00)02077-1.
- Background: PubMed 866038Gronwall DM. Paced auditory serial-addition task: a measure of recovery from concussion. Percept Mot Skills. 1977 Apr;44(2):367-73. doi: 10.2466/pms.1977.44.2.367.
- Background: PubMed 2915783Rao SM, Leo GJ, Haughton VM, St Aubin-Faubert P, Bernardin L. Correlation of magnetic resonance imaging with neuropsychological testing in multiple sclerosis. Neurology. 1989 Feb;39(2 Pt 1):161-6. doi: 10.1212/wnl.39.2.161.
- Individual participant dataSharing planned: No
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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.
Jessica Van Oosterwijck, Prof principal investigator
University Ghent
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 Pain, run by University Ghent at 1 site in Belgium.
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 2 inclusion and 5 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 8 Apr 2022. 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 Belgium. 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.
What does the primary outcome measure?
Conditioned pain modulation (CPM) magnitude (kg/cm²) (time frame: cross-sectional (single test session, day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161286, which also lists 14 linked publications.
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 8 Apr 2022.