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The investigators are investigating whether, when given detailed information about underlying placebo mechanisms and pain, subjects will have a response similar to that of those subjected to a procedure in which they receive a conventional placebo treatment (associated with deception).
STUDY DESIGN: This is a non-inferior parallel, controlled and randomized, single blind trial.
POPULATION: The investigators will include in the study 126 subjects without known pathology. Participants will then be divided into 2 groups on a randomized basis.
METHODOLOGY: Each subject will undergo three sessions of Cold Pressure Test (CPT), a cold pain stimulation method: calibration, condition of interest (conventional placebo or educated placebo) and control. The investigators' main judgment criterion is be the difference in pain intensity experienced on the visual analog scale between the CPT control and the CPT under the condition of interest.
This study will allow the investigators to rule on the non-inferiority of an educated open label placebo compared to a conventional placebo in the context of an acute painful stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educated open label placebo | Active Comparator | These subjects will undergo all the same procedures as in the control group. But before the placebo CTP, they will watch a short movie explaining placebo mechanisms. While applying the placebo cream, they will be told that the cream is inert (placebo), efficient to decrease pain caused by cold and the mechanisms seen in the movie will take place. |
|
| Conventional placebo | Placebo Comparator | These subjects will watch a video on hand washing. While applying the placebo cream, they will be told that this cream is effective to decreased pain caused by cold. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational movie on placebo mechanisms | Other | Educational movie on placebo mechanisms : animated video, duration : 12 minutes. It will be followed by the CPTs : experimentally induced pain by keeping the non dominant hand in cold water (1° Celsius) for a limited time. The duration of immersion is personal and calibrated to be around to ensure that the intensity of pain will be homogeneous (around 7/10 on the visual analogue scale with no treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity: Visual Analogue Scale (VAS) | Evaluated with a Visual Analogue Scale (VAS) from 0 to 100 mm, with a non inferiority margin at 10 mm and a standard deviation at 22 mm. | At the end of the CPT procedure, within 30 seconds after the removal of the hand from the CPT cold water tank. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety respiratory frequency change | Evaluated thanks to the respiratory frequency collect with a PneumoTrace belt through LabChart software. | During the CPT procedure |
| Anxiety blood pressure change |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Safety measure to insure blood pressure does not exceed 150/90mmHg (both systolic/diastolic blood pressure, heart rate) | About 1 minute before every CPT procedures and within 10 secondes after each CPT procedures |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas PINSAULT | Contact | 04 76 76 52 56 | npinsault@chu-grenoble.fr | |
| Carole ROLLAND | Contact | 04 76 76 69 03 | carole.rolland@univ-grenoble-alpes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Leo DRUART | TIMC IMAG Thémas team | Principal Investigator |
| SaraEve GRAHAM LONGSWORTH | TIMC IMAG Thémas team | Principal Investigator |
| Nicolas PINSAULT |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leo Druart | Recruiting | Grenoble | France | |||
| Saraeve Graham Longsworth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21203519 | Background | Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591. | |
| 28708766 | Background | Locher C, Frey Nascimento A, Kirsch I, Kossowsky J, Meyer A, Gaab J. Is the rationale more important than deception? A randomized controlled trial of open-label placebo analgesia. Pain. 2017 Dec;158(12):2320-2328. doi: 10.1097/j.pain.0000000000001012. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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2 groups : Educated open label placebo And Conventional placebo
Each of the subjects will undergo the Cold Pressure text procedure under the condition of interest and a control.
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Only the subjects in the the conventional placebo group will be masked. In the educated open label placebo group, subjects will be aware that the cream is inert.
|
|
| Informative movie on hand washing | Other | Animated video, duration : 11 minutes. It will be followed by the CPTs : experimentally induced pain by keeping the non dominant hand in cold water (1° Celsius) for a limited time. The duration of immersion is personal and calibrated to be around to ensure that the intensity of pain will be homogeneous (around 7/10 on the visual analogue scale with no treatment). |
|
|
Evaluated thanks to the automatic blood pressure monitor (both systolic/diastolic blood pressure, heart rate)
| During the CPT procedure |
| Knowledge of placebo's mechanisms | Evaluated with a questionnaire made for this study with 17 questions about placebo mechanisms. | At the beginning and end of the CPT procedures |
| Perception of the investigator | The perception of the investigator will be evaluated by a visual analogue scale "perception of the investigator". | At the end of the study, when all CPT procedures have been carried out, within 10 minutes after the last immersion |
| The Perceived Awareness of the Research Hypothesis Scale questionnaire | Perception of the research hypothesis with the Rubin Questionnaire. Perceived Awareness of the Research Hypothesis " (PARH) wich is a scale of 4-item quantitative self-report method for measuring the potential influence of demand characteristics in research situations | At the end of the study, when all CPT procedures have been carried out, within 10 minutes after the last immersion |
| TIMC IMAG Thémas team |
| Study Director |
| Recruiting |
| Grenoble |
| France |
| 20592717 | Background | Benedetti F, Carlino E, Pollo A. How placebos change the patient's brain. Neuropsychopharmacology. 2011 Jan;36(1):339-54. doi: 10.1038/npp.2010.81. Epub 2010 Jun 30. |
| 23370213 | Background | Benedetti F, Amanzio M. Mechanisms of the placebo response. Pulm Pharmacol Ther. 2013 Oct;26(5):520-3. doi: 10.1016/j.pupt.2013.01.006. Epub 2013 Jan 28. |
| 29681327 | Background | Colloca L, Howick J. Placebos Without Deception: Outcomes, Mechanisms, and Ethics. Int Rev Neurobiol. 2018;138:219-240. doi: 10.1016/bs.irn.2018.01.005. Epub 2018 Apr 4. |
| 2277714 | Background | Voudouris NJ, Peck CL, Coleman G. The role of conditioning and verbal expectancy in the placebo response. Pain. 1990 Oct;43(1):121-128. doi: 10.1016/0304-3959(90)90057-K. |
| 29681324 | Background | Pecina M, Zubieta JK. Expectancy Modulation of Opioid Neurotransmission. Int Rev Neurobiol. 2018;138:17-37. doi: 10.1016/bs.irn.2018.02.003. Epub 2018 Apr 2. |
| 15162346 | Background | Mitchell LA, MacDonald RA, Brodie EE. Temperature and the cold pressor test. J Pain. 2004 May;5(4):233-7. doi: 10.1016/j.jpain.2004.03.004. |
| 19540783 | Background | Streff A, Kuehl LK, Michaux G, Anton F. Differential physiological effects during tonic painful hand immersion tests using hot and ice water. Eur J Pain. 2010 Mar;14(3):266-72. doi: 10.1016/j.ejpain.2009.05.011. Epub 2009 Jun 21. |
| 27755279 | Background | Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016 Dec;157(12):2766-2772. doi: 10.1097/j.pain.0000000000000700. |
| 37965922 | Derived | Druart L, Graham Longsworth SE, Terrisse H, Locher C, Blease C, Rolland C, Pinsault N. If only they knew! A non-inferiority randomized controlled trial comparing deceptive and open-label placebo in healthy individuals. Eur J Pain. 2024 Mar;28(3):491-501. doi: 10.1002/ejp.2204. Epub 2023 Nov 15. |
| 31906435 | Derived | Druart L, Graham Longsworth S, Rolland C, Dolgopoloff M, Terrisse H, Bosson JL, Pinsault N. Can an Open-Label Placebo Be as Effective as a Deceptive Placebo? Methodological Considerations of a Study Protocol. Medicines (Basel). 2020 Jan 2;7(1):3. doi: 10.3390/medicines7010003. |