Boosting Open-Label Placebo Effects in Acute Induced Pain in Healthy Adults
NCT ID: NCT05819476
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
141 participants
INTERVENTIONAL
2023-03-23
2025-06-30
Brief Summary
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In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated.
In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated
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Detailed Description
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In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated.
In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated (which leaves the last group a choice over when they would like to have the placebo "booster").
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
The second part is designed as a proof-of-concept, randomized, controlled, three-arm trial in a monocentric setup at the University Hospital of Basel.
OTHER
SINGLE
Due to organizational reasons, blinding of the assessor will not be possible in Part 2.
Study Groups
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Part 1: Visit 1 (No treatment) followed by Visit 2 (OLP intervention)
In Part 1, participants will receive one injection (administration of open-label placebo injections without any active ingredient (5 ml 0.9% saline)) at twenty minutes after start of the experiment during the intervention visit 2. Visit 1 (No treatment) will be the control of the study intervention.
OLP-injection
Open-label placebo injections without any active ingredient (5 ml 0.9% saline). All participants will be informed that the administered injections are placebo infusions.
Scripted Evidence-based treatment rationale
As a second component the intervention will consist of an evidence-based treatment rationale, which will be delivered to patients receiving the intervention prior to the OLP-injections, explaining placebo analgesia in pain in general and specifically in OLP. In the context of OLP treatments this rationale is important in order to create a mental state of positive expectations.
Experimental model of acute pain
Experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
Part 1: Visit 1 (OLP intervention) followed by Visit 2 (No treatment)
In Part 1, participants will receive one injection (administration of open-label placebo injections without any active ingredient (5 ml 0.9% saline)) at twenty minutes after start of the experiment during the intervention visit 1. Visit 2 (No treatment) will be the control of the study intervention.
OLP-injection
Open-label placebo injections without any active ingredient (5 ml 0.9% saline). All participants will be informed that the administered injections are placebo infusions.
Scripted Evidence-based treatment rationale
As a second component the intervention will consist of an evidence-based treatment rationale, which will be delivered to patients receiving the intervention prior to the OLP-injections, explaining placebo analgesia in pain in general and specifically in OLP. In the context of OLP treatments this rationale is important in order to create a mental state of positive expectations.
Experimental model of acute pain
Experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
Part 2/ Group A: 1x OLP (Control)
In Part 2, the Group A (Control) receives just one single OLP injection and no repetition.
OLP-injection
Open-label placebo injections without any active ingredient (5 ml 0.9% saline). All participants will be informed that the administered injections are placebo infusions.
Scripted Evidence-based treatment rationale
As a second component the intervention will consist of an evidence-based treatment rationale, which will be delivered to patients receiving the intervention prior to the OLP-injections, explaining placebo analgesia in pain in general and specifically in OLP. In the context of OLP treatments this rationale is important in order to create a mental state of positive expectations.
Experimental model of acute pain
Experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
Part 2/ Group B: 2x OLP; booster time fixed
In Part 2, Group B participants will receive two injections, the first at twenty minutes after start of the experiment, and the second at a time point derived from Part 1 (if data is inconclusive; at 100 minutes).
For every subsequent OLP administration, patients will be reminded of the inertness of the injection and that this injection might help with regulating pain.
OLP-injection
Open-label placebo injections without any active ingredient (5 ml 0.9% saline). All participants will be informed that the administered injections are placebo infusions.
Scripted Evidence-based treatment rationale
As a second component the intervention will consist of an evidence-based treatment rationale, which will be delivered to patients receiving the intervention prior to the OLP-injections, explaining placebo analgesia in pain in general and specifically in OLP. In the context of OLP treatments this rationale is important in order to create a mental state of positive expectations.
Experimental model of acute pain
Experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
Part 2/ Group C: 2x OLP; booster on- demand
In Part 2, Group C participants will receive two injections, the first at twenty minutes after start of the experiment, and the second on demand.
For every subsequent OLP administration, patients will be reminded of the inertness of the injection and that this injection might help with regulating pain.
OLP-injection
Open-label placebo injections without any active ingredient (5 ml 0.9% saline). All participants will be informed that the administered injections are placebo infusions.
Scripted Evidence-based treatment rationale
As a second component the intervention will consist of an evidence-based treatment rationale, which will be delivered to patients receiving the intervention prior to the OLP-injections, explaining placebo analgesia in pain in general and specifically in OLP. In the context of OLP treatments this rationale is important in order to create a mental state of positive expectations.
Experimental model of acute pain
Experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
Interventions
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OLP-injection
Open-label placebo injections without any active ingredient (5 ml 0.9% saline). All participants will be informed that the administered injections are placebo infusions.
Scripted Evidence-based treatment rationale
As a second component the intervention will consist of an evidence-based treatment rationale, which will be delivered to patients receiving the intervention prior to the OLP-injections, explaining placebo analgesia in pain in general and specifically in OLP. In the context of OLP treatments this rationale is important in order to create a mental state of positive expectations.
Experimental model of acute pain
Experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
Eligibility Criteria
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Inclusion Criteria
* BMI between 18 and 25kg/m2
* Able to understand the study and the NRS
* Able to give informed consent
Exclusion Criteria
* Regular intake of medications or drugs potentially interfering with pain sensation (analgesics, opioids, antihistamines, calcium and potassium channel blockers, serotonin/ noradrenaline reuptake inhibitors, corticosteroids)
* Neuropathy
* Chronic pain
* Neuromuscular disease
* Dermatological disease (i.e. Atopic Dermatitis)
* Psychiatric disease
* Pregnancy / Lactation
18 Years
65 Years
ALL
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Tobias Schneider, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology, University Hospital of Basel (USB)
Locations
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University Hospital of Basel (USB); Department of Anaesthesiology
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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de Leeuw M, Laager M, Gaab J, Ruppen W, Schneider T. Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial. Front Med (Lausanne). 2024 Feb 14;11:1238878. doi: 10.3389/fmed.2024.1238878. eCollection 2024.
Other Identifiers
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2023-00296; am23Schneider
Identifier Type: -
Identifier Source: org_study_id
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