Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults

Study Overview
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Brief Summary
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Open Label Placebo application has been shown to be effective in treatment of chronic pain (low back pain) and disease like the irritable bowel Syndrome. Data about effects on acute pain are spare. The study investigates the effect of an open-label Placebo (substance without a medical active component) application on acute pain, evoked via a artificial pain model in healthy male volunteers. 32 healthy male volunteers are recruited.

Official Title
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Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults - A Randomized Single Blinded Clinical Trail

Conditions
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Acute Pain

Intervention / Treatment
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* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers (American Society of Anaesthesiologist's Class I or II) Body mass index between 18 and 25kg/m2 Able to understand the study and the NRS scale Able to give informed consent Exclusion Criteria: Recreational drug abuse Regularly taking medication potentially interfere with pain sensation (analgesics, antihistamines and calcium and potassium channel blockers) Neuropathy Chronic pain Neuromuscular or psychiatric disease Known or suspected kidney or liver disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: investigator blinded, cross over design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo education group<br>Prior to the intervention during the Placebo is given, the volunteer receives a detailed information about the effect and the strength of an open-label placebo. This education is performed via a slide show and a news report video. The important terms for Placebo analgesia: positive expectations, conditioning, communication are discussed | Other: Education<br>* c.p. intervention description<br>|
| Other: Placebo non education group<br>No detailed Information about open-label placebo prior to the intervention. The volunteer is told about the possible strength of the Placebo effect on pain directly before the application. | Other: Education<br>* c.p. intervention description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response measured by the Area under the Pain Curve (AUPC) | Pain response measured by creating the Area under the Pain Curve (AUPC), using the numeric rating scale (NRS) from minute 30 to 100 during constant induced pain with electrical current at the forearm of the participant. Measuring of pain every 10 minutes from minute 30 to 100 (Minute 30,40,50,60,70,80,90, 100) in an experimental setting. Main comparison: The effect of open label placebo v.s. no treatment intervention | 30 minutes after baseline until 100 minutes after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in pain response measured by the AUPC due to education | The pain response measured by the AUPC in participants received a detailed education about open label Placebo compared to those who received a short education direct prior to placebo administration. | 30 minutes after baseline until 100 minutes after baseline | 
| hyperalgesia | Hyperalgesia will be measured analogously to the NRS | 100min | 
| Saliva cortisol concentration in μg/dL | Saliva concentration of cortisol, will be measured 4 times: at baseline, 30, 60 and 100 minutes during pain induction | baseline until 100 min after baseline | 
| allodynia | allodynia will be measured analogously to the NRS | 100minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Placebo