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Trial record 61 of 58406 for:    Placebo

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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment Phase
Acute Pain Other: Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
Other: Education
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.
Other: Education
c.p. intervention description




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. hyperalgesia [ Time Frame: 100min ]
    Hyperalgesia will be measured analogously to the NRS

  3. 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

  4. allodynia [ Time Frame: 100minutes ]
    allodynia will be measured analogously to the NRS



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Switzerland
University Hospital Basel
Basel, Basel Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Director: Wilhelm Ruppen, PD Dep. Anesthesiology University Hospital Basel
  Study Documents (Full-Text)

Documents provided by University Hospital, Basel, Switzerland:

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03361579     History of Changes
Other Study ID Numbers: 2017-01690
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
Placebo

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms