Acute PainPLACETHICNCT03934138
Does the Understanding of Placebo Mechanisms Compensate for the Loss of Efficacy Associated With Open Label Placebo
A study testing Informative movie on hand washing in people with Acute Pain, run by Laboratoire TIMC-IMAG at 2 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Informative movie on hand washing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 2 sitesFrance
- Study dates
- 3 May 2019to 1 Sep 2020
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Person affiliated to Social Security
- Informed consent, written and signed by the subject.
Who cannot join
- Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (CSP), which corresponds to all protected persons: pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure, cannot be included in clinical trials.
- Persons with a pathology against indicating the use of CPT experimentally induced pain :
- Any pathologies affecting the venous, arterial or lymphatic system
- Diabetes
- Cardiac disorders
- Asthma
Show all 12Show fewer
- Frostbite
- Epilepsy
- Arthritis
- Lupus erythematosus
- Allergy to Cremafluid® cream
- Person with concomitant treatment that modifies sensitivity to pain, chronic or acute at the time of the experiment, such as analgesics, psychotropic drugs or anti-inflammatories.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Leo Druart
Grenoble
- Recruiting
Saraeve Graham Longsworth
Grenoble
About this study
Official title: Does the Subject's Understanding of Underlying Placebo Mechanisms Compensate for the Loss of Efficacy Associated With the Disclosure of the Use of a Placebo
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.
Read more
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.
- Conditions
- Acute Pain
- Being tested
- Educational movie on placebo mechanisms, Informative movie on hand washing
- Keywords
- Placebo, Experimental pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational movie on placebo mechanismsOther
Also called Cold Pressure Test (CPT)
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)
Informative movie on hand washingOther
Also called Cold Pressure Test (CPT)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational movie on placebo mechanisms |
| 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. Receives: Other: Informative movie on hand washing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the CPT procedure, within 30 seconds after the removal of the hand from the CPT cold water tank.
Secondary outcomes (5)
Anxiety respiratory frequency change
Evaluated thanks to the respiratory frequency collect with a PneumoTrace belt through LabChart software.
Measured: During the CPT procedure
Anxiety blood pressure change
Evaluated thanks to the automatic blood pressure monitor (both systolic/diastolic blood pressure, heart rate)
Measured: During the CPT procedure
Knowledge of placebo's mechanisms
Evaluated with a questionnaire made for this study with 17 questions about placebo mechanisms.
Measured: 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".
Measured: 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
Measured: At the end of the study, when all CPT procedures have been carried out, within 10 minutes after the last immersion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start3 May 2019
- Primary completion3 May 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoire TIMC-IMAG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leo DRUART, Principal investigator, TIMC IMAG Thémas teamSaraEve GRAHAM LONGSWORTH, Principal investigator, TIMC IMAG Thémas teamNicolas PINSAULT, Study director, TIMC IMAG Thémas team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934138
- Sponsor's protocol ID
- 2017-A01643-50
- Acronym
- PLACETHIC
- Status last verified
- May 2019
- First submitted
- 24 Apr 2019
- Last updated
- 16 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21203519Locher 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.
PubMed 28708766Benedetti 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.
PubMed 20592717Benedetti 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.
PubMed 23370213Colloca 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.
PubMed 29681327Voudouris 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.
PubMed 2277714Pecina 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.
PubMed 29681324Mitchell 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.
PubMed 15162346Streff 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.
PubMed 19540783Carvalho 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.
PubMed 27755279Druart 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.
PubMed 37965922Druart 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.
PubMed 31906435
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Subject's Understanding of Underlying Placebo Mechanisms Compensate for the Loss of Efficacy Associated With the Disclosure of the Use of a Placebo
- ClinicalTrials.gov ID
- NCT03934138
- Acronym / sponsor ID
- PLACETHIC / 2017-A01643-50
- Conditions
- Acute Pain
- Keywords
- Placebo, Experimental pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Laboratoire TIMC-IMAGUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 3 May 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 1 May 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Educated open label placebo | Active comparator | Other: Educational movie on placebo mechanismsThese 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 | Other: Informative movie on hand washingThese 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Person affiliated to Social Security
- Informed consent, written and signed by the subject.
Key exclusion criteria (12 listed)
- Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (CSP), which corresponds to all protected persons: pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure, cannot be included in clinical trials.
- Persons with a pathology against indicating the use of CPT experimentally induced pain :
- Any pathologies affecting the venous, arterial or lymphatic system
- Diabetes
- Cardiac disorders
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 |
|---|---|---|
| Educational movie on placebo mechanismsAlso: Cold Pressure Test (CPT)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) | Other | Educated open label placebo |
| Informative movie on hand washingAlso: Cold Pressure Test (CPT)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). | Other | Conventional placebo |
Primary outcome
Pain intensity: Visual Analogue Scale (VAS)
Time frame: At the end of the CPT procedure, within 30 seconds after the removal of the hand from the CPT cold water tank.
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.
5 secondary outcomes
Anxiety respiratory frequency change
Time frame: During the CPT procedure
Anxiety blood pressure change
Time frame: During the CPT procedure
Knowledge of placebo's mechanisms
Time frame: At the beginning and end of the CPT procedures
Perception of the investigator
Time frame: 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
Time frame: At the end of the study, when all CPT procedures have been carried out, within 10 minutes after the last immersion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Background: PubMed 21203519Kaptchuk 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.
- Background: PubMed 28708766Locher 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.
- Background: PubMed 20592717Benedetti 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.
- Background: PubMed 23370213Benedetti 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.
- Background: PubMed 29681327Colloca 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.
- Background: PubMed 2277714Voudouris 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.
- Background: PubMed 29681324Pecina 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.
- Background: PubMed 15162346Mitchell 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.
- Background: PubMed 19540783Streff 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.
- Background: PubMed 27755279Carvalho 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.
- Derived from this study: PubMed 37965922Druart 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.
- Derived from this study: PubMed 31906435Druart 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.
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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.
Leo DRUART principal investigator
TIMC IMAG Thémas team
SaraEve GRAHAM LONGSWORTH principal investigator
TIMC IMAG Thémas team
Nicolas PINSAULT study director
TIMC IMAG Thémas team
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informative movie on hand washing in people with Acute Pain, run by Laboratoire TIMC-IMAG at 2 sites in France.
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 12 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: status not confirmed, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas PINSAULT (04 76 76 52 56, npinsault@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity: Visual Analogue Scale (VAS) (time frame: At the end of the CPT procedure, within 30 seconds after the removal of the hand from the CPT cold water tank.). 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 NCT03934138, which also lists 12 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 16 May 2019.