Back to resultsPain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults (POLAP)
Primary Purpose
Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Education
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Placebo
Eligibility Criteria
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
Sites / Locations
- University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Placebo education group
Placebo non education group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
hyperalgesia
Hyperalgesia will be measured analogously to the NRS
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
allodynia
allodynia will be measured analogously to the NRS
Full Information
NCT ID
NCT03361579
First Posted
November 17, 2017
Last Updated
May 15, 2018
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT03361579
Brief Title
Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults
Acronym
POLAP
Official Title
Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults - A Randomized Single Blinded Clinical Trail
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 11, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
investigator blinded, cross over design
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo education group
Arm Type
Other
Arm Description
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
Arm Title
Placebo non education group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
c.p. intervention description
Primary Outcome Measure Information:
Title
Pain response measured by the Area under the Pain Curve (AUPC)
Description
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
Time Frame
30 minutes after baseline until 100 minutes after baseline
Secondary Outcome Measure Information:
Title
Differences in pain response measured by the AUPC due to education
Description
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.
Time Frame
30 minutes after baseline until 100 minutes after baseline
Title
hyperalgesia
Description
Hyperalgesia will be measured analogously to the NRS
Time Frame
100min
Title
Saliva cortisol concentration in μg/dL
Description
Saliva concentration of cortisol, will be measured 4 times: at baseline, 30, 60 and 100 minutes during pain induction
Time Frame
baseline until 100 min after baseline
Title
allodynia
Description
allodynia will be measured analogously to the NRS
Time Frame
100minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilhelm Ruppen, PD
Organizational Affiliation
Dep. Anesthesiology University Hospital Basel
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults
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