PainNCT05284383
Reducing Nocebo Effects on Pressure Pain
A study testing Closed-label nocebo conditioning, Closed-label counterconditioning and Open-label counterconditioning in people with Pain and Hyperalgesia, run by Leiden University at 1 site in Netherlands.
Trial summary
Nocebo effects are known to adversely affect the experience of various physical symptoms, such as pain and itch. Nocebo effects can be induced by associative learning mechanisms of classical conditioning. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Hyperalgesia
- What is being tested?
- Closed-label nocebo conditioning, Closed-label counterconditioning and Open-label counterconditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Mar 2021to 5 Apr 2022
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-35 years
- Good understanding of written and spoken Dutch or English
Who cannot join
- Severe somatic or psychiatric morbidity (e.g., heart/lung diseases, DSM-V psychiatric disorders)
- Raynaud's disease, chronic pain complaints at present or in the past
- Current pain complaints (> 2 on NRS)
- Current use of medication (except for birth-control pill)
- Injuries on the non-dominant hand
- Refusal/inability to remove nail polish or artificial nails for the experiment
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Nocebo Effects on Pressure Pain: open-and Closed-label Counterconditioning and Extinction Compared
Nocebo effects are known to adversely affect the experience of various physical symptoms, such as pain and itch. Nocebo effects can be induced by associative learning mechanisms of classical conditioning. Furthermore, recent studies have shown that counterconditioning can successfully reduce nocebo effects, and to a larger extent than mere extinction, which suggests counterconditioning can be an innovative method for desensitization of symptoms. When using such procedures in clinical practice, deception of patients should be avoided as much as possible. The use of open-label procedures could provide a promising alternative. While previous studies have already shown that open-label placebos are effective, the effects of open-label counterconditioning and closed-label counterconditioning are not extensively investigated in comparison to other strategies, such as extinction, and not yet compared amongst each other. Before implementing such a procedure in clinical practice, it would be relevant to get an insight in the efficacy of both open- and closed-label counterconditioning in healthy participants as compared to extinction and to investigate whether open-label counterconditioning can be equally effective as closed-label counterconditioning. Furthermore, it would be relevant to study the induction and reduction of nocebo effects using a pain modality that mimics the type of pain that people suffering from several chronic pain conditions experience, such as pressure pain. The main aim of the current study is to investigate whether open- and closed-label counterconditioning are more effective in reducing nocebo effects than extinction. To this aim, it will be investigated whether open- and closed-label counterconditioning lead to stronger reductions in nocebo effects on pressure pain than (closed-label) extinction, and whether all three successfully reduce nocebo effects. Finally, it will be tested whether open- and closed label counterconditioning are comparable in effectivity.
Read the detailed description
The primary objective of the study is to investigate whether open- and closed-label counterconditioning are more effective in reducing nocebo effects than extinction.
The experimental (open- and closed-label counterconditioning) and control (extinction) groups will be compared on the change in the nocebo effect from before to after counterconditioning. The nocebo effect is defined as the mean difference in self-reported pain ratings (on a numeric rating scale from 0 (no pain) to 10 (worst pain imaginable))during all experimental trials and control trials in the test phase of nocebo conditioning and the test phase of counterconditioning/extinction. The reduction of the nocebo effect will be determined by calculating the mean difference between the nocebo effect after conditioning and after counterconditioning/extinction. It is expected that participants in both counterconditioning groups will show a larger reduction of the nocebo effect than participants in the extinction group. A one-way ANOVA will be conducted, to examine the main effect of group on the amount of change in nocebo effects. Then, post-hoc analyses will be conducted after the primary analysis, to test for differences between the three forms of nocebo reduction.
Secondary, it will be tested whether all three procedures (open- and closed-label counterconditioning and extinction) lead to a significant reduction of the nocebo effect, by comparing the amount of reduction to test value 0. It is hypothesized that all groups show a significant reduction.
Finally, it will be investigated whether open- and closed-label counterconditioning procedures are comparable in terms of their ability to reduce nocebo effects on pressure pain. Both groups are expected to be comparable in efficacy of reducing the nocebo effect.
- Conditions
- Pain, Hyperalgesia
- Being tested
- Closed-label nocebo conditioning, Closed-label counterconditioning, Open-label counterconditioning, Closed-label extinction
- Keywords
- Pressure pain, Nocebo effect, Conditioning, Counterconditioning
- Medical subject headings
- Pain, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-label nocebo conditioningBehavioural
Conditioning consists of a learning and test phase. In the learning phase, a message indicating the sham activation of a Transcutaneous Electrical Nerve Stimulation (TENS) device (CS) will be repeatedly paired with a moderate intensity pressure pain stimulus, whereas a message indicating the deactivation of the sham device will be repeatedly paired with a slightly painful pressure pain stimulus. Participants will be given a verbal suggestion in line with the conditioning procedure (i.e. activation of the device will increase their pain). The testing phase is similar to the learning phase, but a slight pressure pain intensity is used for all trials, to test for a nocebo effect (i.e. to test whether participants score "TENS on" trials as more painful than "TENS off" trials).
Closed-label counterconditioningBehavioural
Counterconditioning consists of a learning and test phase. In the learning phase, a message indicating the sham activation of the TENS device (CS) is now repeatedly paired with a non-painful intensity pressure pain stimulus, whereas a message indicating the sham deactivation of the TENS device will be repeatedly paired with a slightly painful pressure pain stimulus. Participants will be given a verbal suggestion in line with the counterconditioning procedure (i.e. activation of the device will reduce their pain). The testing phase is similar to the learning phase, but a slight pressure pain intensity is used for all trials, to test whether the nocebo effect is successfully reduced (i.e. to test whether participants no longer score "TENS on" trials as more painful than "TENS off" trials or even score "TENS on" trials as less painful).
Open-label counterconditioningBehavioural
Counterconditioning consists of a learning and test phase. In the learning phase, a message indicating the sham activation of the TENS device (CS) is now repeatedly paired with a non-painful intensity pressure pain stimulus, whereas a message indicating the sham deactivation of the TENS device will be repeatedly paired with a slightly painful pressure pain stimulus. Participants will be given a open-label verbal suggestions in line with the counterconditioning procedure (i.e. they are told counterconditioning will be used to reduce nocebo effects and they are told the device is sham, but that their pain will still be influenced because of the placebo effect). The testing phase is similar to the learning phase, but a slight pressure pain intensity is used for all trials, to test whether the nocebo effect is successfully reduced (i.e. to test whether participants no longer score "TENS on" trials as more painful than "TENS off" trials or even score "TENS on" trials as less painful).
Closed-label extinctionBehavioural
Extinction consists of a learning and test phase. In the learning phase, slightly painful stimuli are used for all trials. During the testing phase, again a slight pressure pain intensity is used for all trials, to test whether the nocebo effect is successfully reduced (i.e. to test whether participants no longer score "TENS on" trials as more painful than "TENS off" trials).
| Study group | Role | What they receive |
|---|---|---|
| Open-label counterconditioning | Experimental | Closed-label conditioning followed by open-label counterconditioning, using moderately painful stimuli (during conditioning) and non-painful stimuli (during counterconditioning), combined with closed-label nocebo suggestions and open-label nocebo reduction suggestions Receives: Behavioral: Closed-label nocebo conditioning; Behavioral: Open-label counterconditioning |
| Closed-label counterconditioning | Experimental | Closed-label conditioning followed by closed-label counterconditioning, using moderately painful stimuli (during conditioning) and non-painful stimuli (during counterconditioning), combined with closed-label nocebo suggestions and closed-label nocebo reduction suggestions Receives: Behavioral: Closed-label nocebo conditioning; Behavioral: Closed-label counterconditioning |
| Closed-label extinction | Active comparator | Closed-label conditioning followed by closed-label extinction, using moderately painful stimuli (during conditioning) and slightly-painful stimuli (during extinction), combined with closed-label nocebo suggestions during conditioning and no/neutral suggestions during extinction Receives: Behavioral: Closed-label nocebo conditioning; Behavioral: Closed-label extinction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocebo reduction; group comparison
The change in nocebo effects from after nocebo conditioning (part 1) to after either form of counterconditioning or extinction (part 2) will be compared between groups. The nocebo effect is defined as the difference between the pain scored during experimental trials (on a 0-10 NRS) and during control trials (same NRS). The change is calculated by subtracting the nocebo effect after counterconditioning from the nocebo effect after nocebo conditioning.
Measured: On the testing day; testing phase of nocebo induction and reduction
Secondary outcomes (2)
Nocebo reduction
For all three groups separately, it will be tested whether the nocebo effect is significantly reduced from test phase of nocebo conditioning to the test phase of either form of counterconditioning or extinction. The nocebo effect is defined as the difference between the pain scored during experimental trials (on a 0-10 NRS) and during control trials (same NRS). Nocebo reduction is calculated by subtracting the nocebo effect after counterconditioning from the nocebo effect after nocebo conditioning. For all groups separately, the amount of reduction will be compared to test value 0.
Measured: On the testing day; testing phase of nocebo induction and reduction
Nocebo reduction; equivalence of the two forms of counterconditioning
It will be tested whether the change in nocebo effects from the test phase of conditioning to the test phase of counterconditioning in the open- and closed-label groups is comparable. The nocebo effect is defined as the difference between the pain scored during experimental trials (on 0-10 NRS) and during control trials (same NRS). The change is calculated by subtracting the nocebo effects after counterconditioning from the nocebo effect after nocebo conditioning.
Measured: On the testing day; testing phase of nocebo induction and reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start23 Mar 2021
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea W.M Evers, PhD, Leiden University Medical Center
- Investigators
- Andrea Evers, Prof, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284383
- Sponsor's protocol ID
- 2020-02-04-A.W.M.Evers-V1-2085
- Status last verified
- Aug 2022
- First submitted
- 17 Feb 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data are collected pseudonymised; consent forms are the only sources containing personal data and will not be shared, but are monitored by the department's Data Monitor.
Publications
Meijer S, Evers AWM, Peerdeman KJ, van Middendorp H. Can Nocebo Effects Be Reduced via Open- and Closed-Label Counterconditioning? Eur J Pain. 2026 Mar;30(3):e70248. doi: 10.1002/ejp.70248.
PubMed 41821263
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Nocebo Effects on Pressure Pain: open-and Closed-label Counterconditioning and Extinction Compared
- ClinicalTrials.gov ID
- NCT05284383
- Acronym / sponsor ID
- 2020-02-04-A.W.M.Evers-V1-2085
- Conditions
- Pain, Hyperalgesia
- Keywords
- Pressure pain, Nocebo effect, Conditioning, Counterconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 17 Mar 2022 (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.
Nocebo effects are known to adversely affect the experience of various physical symptoms, such as pain and itch. Nocebo effects can be induced by associative learning mechanisms of classical conditioning. Furthermore, recent studies have shown that counterconditioning can successfully reduce nocebo effects, and to a larger extent than mere extinction, which suggests counterconditioning can be an innovative method for desensitization of symptoms. When using such procedures in clinical practice, deception of patients should be avoided as much as possible. The use of open-label procedures could provide a promising alternative. While previous studies have already shown that open-label placebos are effective, the effects of open-label counterconditioning and closed-label counterconditioning are not extensively investigated in comparison to other strategies, such as extinction, and not yet compared amongst each other. Before implementing such a procedure in clinical practice, it would be relevant to get an insight in the efficacy of both open- and closed-label counterconditioning in healthy participants as compared to extinction and to investigate whether open-label counterconditioning can be equally effective as closed-label counterconditioning. Furthermore, it would be relevant to study the induction and reduction of nocebo effects using a pain modality that mimics the type of pain that people suffering from several chronic pain conditions experience, such as pressure pain. The main aim of the current study is to investigate whether open- and closed-label counterconditioning are more effective in reducing nocebo effects than extinction. To this aim, it will be investigated whether open- and closed-label counterconditioning lead to stronger reductions in nocebo effects on pressure pain than (closed-label) extinction, and whether all three successfully reduce nocebo effects. Finally, it will be tested whether open- and closed label counterconditioning are comparable in effectivity.
Detailed description
The primary objective of the study is to investigate whether open- and closed-label counterconditioning are more effective in reducing nocebo effects than extinction.
The experimental (open- and closed-label counterconditioning) and control (extinction) groups will be compared on the change in the nocebo effect from before to after counterconditioning. The nocebo effect is defined as the mean difference in self-reported pain ratings (on a numeric rating scale from 0 (no pain) to 10 (worst pain imaginable))during all experimental trials and control trials in the test phase of nocebo conditioning and the test phase of counterconditioning/extinction. The reduction of the nocebo effect will be determined by calculating the mean difference between the nocebo effect after conditioning and after counterconditioning/extinction. It is expected that participants in both counterconditioning groups will show a larger reduction of the nocebo effect than participants in the extinction group. A one-way ANOVA will be conducted, to examine the main effect of group on the amount of change in nocebo effects. Then, post-hoc analyses will be conducted after the primary analysis, to test for differences between the three forms of nocebo reduction.
Secondary, it will be tested whether all three procedures (open- and closed-label counterconditioning and extinction) lead to a significant reduction of the nocebo effect, by comparing the amount of reduction to test value 0. It is hypothesized that all groups show a significant reduction.
Finally, it will be investigated whether open- and closed-label counterconditioning procedures are comparable in terms of their ability to reduce nocebo effects on pressure pain. Both groups are expected to be comparable in efficacy of reducing the nocebo effect.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open-label counterconditioning | Experimental | Behavioral: Closed-label nocebo conditioning, Behavioral: Open-label counterconditioningClosed-label conditioning followed by open-label counterconditioning, using moderately painful stimuli (during conditioning) and non-painful stimuli (during counterconditioning), combined with closed-label nocebo suggestions and open-label nocebo reduction suggestions |
| Closed-label counterconditioning | Experimental | Behavioral: Closed-label nocebo conditioning, Behavioral: Closed-label counterconditioningClosed-label conditioning followed by closed-label counterconditioning, using moderately painful stimuli (during conditioning) and non-painful stimuli (during counterconditioning), combined with closed-label nocebo suggestions and closed-label nocebo reduction suggestions |
| Closed-label extinction | Active comparator | Behavioral: Closed-label nocebo conditioning, Behavioral: Closed-label extinctionClosed-label conditioning followed by closed-label extinction, using moderately painful stimuli (during conditioning) and slightly-painful stimuli (during extinction), combined with closed-label nocebo suggestions during conditioning and no/neutral suggestions during extinction |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-35 years
- Good understanding of written and spoken Dutch or English
Key exclusion criteria (7 listed)
- Severe somatic or psychiatric morbidity (e.g., heart/lung diseases, DSM-V psychiatric disorders)
- Raynaud's disease, chronic pain complaints at present or in the past
- Current pain complaints (> 2 on NRS)
- Current use of medication (except for birth-control pill)
- Injuries on the non-dominant hand
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 |
|---|---|---|
| Closed-label nocebo conditioningConditioning consists of a learning and test phase. In the learning phase, a message indicating the sham activation of a Transcutaneous Electrical Nerve Stimulation (TENS) device (CS) will be repeatedly paired with a moderate intensity pressure pain stimulus, whereas a message indicating the deactivation of the sham device will be repeatedly paired with a slightly painful pressure pain stimulus. Participants will be given a verbal suggestion in line with the conditioning procedure (i.e. activation of the device will increase their pain). The testing phase is similar to the learning phase, but a slight pressure pain intensity is used for all trials, to test for a nocebo effect (i.e. to test whether participants score "TENS on" trials as more painful than "TENS off" trials). | Behavioural | Closed-label counterconditioning, Closed-label extinction, Open-label counterconditioning |
| Closed-label counterconditioningCounterconditioning consists of a learning and test phase. In the learning phase, a message indicating the sham activation of the TENS device (CS) is now repeatedly paired with a non-painful intensity pressure pain stimulus, whereas a message indicating the sham deactivation of the TENS device will be repeatedly paired with a slightly painful pressure pain stimulus. Participants will be given a verbal suggestion in line with the counterconditioning procedure (i.e. activation of the device will reduce their pain). The testing phase is similar to the learning phase, but a slight pressure pain intensity is used for all trials, to test whether the nocebo effect is successfully reduced (i.e. to test whether participants no longer score "TENS on" trials as more painful than "TENS off" trials or even score "TENS on" trials as less painful). | Behavioural | Closed-label counterconditioning |
| Open-label counterconditioningCounterconditioning consists of a learning and test phase. In the learning phase, a message indicating the sham activation of the TENS device (CS) is now repeatedly paired with a non-painful intensity pressure pain stimulus, whereas a message indicating the sham deactivation of the TENS device will be repeatedly paired with a slightly painful pressure pain stimulus. Participants will be given a open-label verbal suggestions in line with the counterconditioning procedure (i.e. they are told counterconditioning will be used to reduce nocebo effects and they are told the device is sham, but that their pain will still be influenced because of the placebo effect). The testing phase is similar to the learning phase, but a slight pressure pain intensity is used for all trials, to test whether the nocebo effect is successfully reduced (i.e. to test whether participants no longer score "TENS on" trials as more painful than "TENS off" trials or even score "TENS on" trials as less painful). | Behavioural | Open-label counterconditioning |
| Closed-label extinctionExtinction consists of a learning and test phase. In the learning phase, slightly painful stimuli are used for all trials. During the testing phase, again a slight pressure pain intensity is used for all trials, to test whether the nocebo effect is successfully reduced (i.e. to test whether participants no longer score "TENS on" trials as more painful than "TENS off" trials). | Behavioural | Closed-label extinction |
Primary outcome
Nocebo reduction; group comparison
Time frame: On the testing day; testing phase of nocebo induction and reduction
The change in nocebo effects from after nocebo conditioning (part 1) to after either form of counterconditioning or extinction (part 2) will be compared between groups. The nocebo effect is defined as the difference between the pain scored during experimental trials (on a 0-10 NRS) and during control trials (same NRS). The change is calculated by subtracting the nocebo effect after counterconditioning from the nocebo effect after nocebo conditioning.
2 secondary outcomes
Nocebo reduction
Time frame: On the testing day; testing phase of nocebo induction and reduction
Nocebo reduction; equivalence of the two forms of counterconditioning
Time frame: On the testing day; testing phase of nocebo induction and reduction
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 25 Aug 2022.
- Derived from this study: PubMed 41821263Meijer S, Evers AWM, Peerdeman KJ, van Middendorp H. Can Nocebo Effects Be Reduced via Open- and Closed-Label Counterconditioning? Eur J Pain. 2026 Mar;30(3):e70248. doi: 10.1002/ejp.70248.
- Individual participant dataSharing planned: Yes. All data are collected pseudonymised; consent forms are the only sources containing personal data and will not be shared, but are monitored by the department's Data Monitor.
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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.
Andrea Evers, Prof principal investigator
Leiden University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-label nocebo conditioning, Closed-label counterconditioning and Open-label counterconditioning in people with Pain and Hyperalgesia, run by Leiden University at 1 site in Netherlands.
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 7 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 25 Aug 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 Netherlands. 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?
Nocebo reduction; group comparison (time frame: On the testing day; testing phase of nocebo induction and reduction). 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 NCT05284383, 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 25 Aug 2022.