The Influence of Expectations, Attention and the Test Paradigm on the Efficacy of the Pain Processing System

NCT05161286 | Completed

• 1 other identifier: BC-08516
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Pain

Keywords

endogenous pain modulation; conditioned pain modulation; expectations; attention; test paradigm

Outcome Measures

Primary Outcomes (1)

• 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.

  cross-sectional (single test session, day 0)

Secondary Outcomes (2)

• Sociodemographic and health-related characteristics

  cross-sectional (single test session, day 0)

• Hospital Anxiety and Depression Scale (HADS)

  cross-sectional (single test session, day 0)

Study Arms (1)

Healthy pain-free cohort

Healthy pain-free Dutch-speaking men and women between the age of 18 and 65 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Dutch speaking participants (age between 18 and 65 years)
• Healthy volunteers who have no pain complaints

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University, Dept. of Rehabilitation Sciences

Ghent, 9000, Belgium

Location

Related Publications (14)

• 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.

  PMID: 25330039 BACKGROUND

• Goffaux 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.

  PMID: 17215080 BACKGROUND

• Bjorkedal 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.

  PMID: 23049277 BACKGROUND

• Lewis 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.

  PMID: 24325269 BACKGROUND

• Cormier 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.

  PMID: 23260452 BACKGROUND

• France 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.

  PMID: 26809850 BACKGROUND

• Kennedy 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.

  PMID: 27559835 BACKGROUND

• Nir 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.

  PMID: 21035364 BACKGROUND

• Nir 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.

  PMID: 22119318 BACKGROUND

• Reinert 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.

  PMID: 10799674 BACKGROUND

• Gronwall 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.

  PMID: 866038 BACKGROUND

• Rao 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.

  PMID: 2915783 BACKGROUND

• Rao 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.

  PMID: 2027484 BACKGROUND

• Billens 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.

  PMID: 40542602 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica Van Oosterwijck, Prof

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: December 17, 2021
• Study Start: August 12, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 8, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)