Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults (POLAP)
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|ClinicalTrials.gov Identifier: NCT03361579|
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : May 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Other: Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||investigator blinded, cross over design|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The investigator is blinded about the source of education a participant recieved prior to Placebo application. Investigator is blinded about during which Intervention the Placebo is applicated|
|Official Title:||Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults - A Randomized Single Blinded Clinical Trail|
|Actual Study Start Date :||November 11, 2017|
|Actual Primary Completion Date :||March 30, 2018|
|Actual Study Completion Date :||March 30, 2018|
Placebo education group
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
c.p. intervention description
Placebo non education group
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.
c.p. intervention description
- Pain response measured by the Area under the Pain Curve (AUPC) [ Time Frame: 30 minutes after baseline until 100 minutes after baseline ]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
- Differences in pain response measured by the AUPC due to education [ Time Frame: 30 minutes after baseline until 100 minutes after baseline ]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.
- hyperalgesia [ Time Frame: 100min ]Hyperalgesia will be measured analogously to the NRS
- Saliva cortisol concentration in μg/dL [ Time Frame: baseline until 100 min after baseline ]Saliva concentration of cortisol, will be measured 4 times: at baseline, 30, 60 and 100 minutes during pain induction
- allodynia [ Time Frame: 100minutes ]allodynia will be measured analogously to the NRS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361579
|University Hospital Basel|
|Basel, Basel Stadt, Switzerland, 4031|
|Study Director:||Wilhelm Ruppen, PD||Dep. Anesthesiology University Hospital Basel|