Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 33793 for:    Placebo AND placebo effect

Experimental Pain Reporting Accuracy and Placebo Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03950999
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Roi Treister, University of Haifa

Brief Summary:
Good clinical care relies on precise evaluation of patients' conditions. Chronic pain and other neurological and psychiatric diagnoses pose challenges because their assessment depends on subjective patient-reported outcome measures (PROs). The investigators have recently developed the Focused Analgesia Selection Task (FAST), a method that allows assessing pain reporting accuracy. Preliminary results suggest that those who more accurately report their pain show diminished placebo response. The underlying mechanisms for this observation cannot be explained by current theories. Therefore, the investigators have conducted a pilot study to further characterize this relation in healthy population.

Condition or disease Intervention/treatment Phase
Healthy Placebo Effect Pain Other: Placebo Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pain and Placebo - a Study to Examine Relations Between Pain Reporting Accuracy and the Response to Experimental Placebo Model
Actual Study Start Date : August 13, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Study arm
Each subject underwent baseline assessment of pain reporting accuracy (FAST). Thereafter, the placebo response was assessed using tonic heat stimuli delivered at fixed temperature of 44, 46.5, and 48°C which evoke mild, moderate and severe pain sensations (in accordance). The stimuli were given in a pseudo-random order twice, once before receiving the placebo pill (a sugar pill) and once after, maintaining the same order as before.
Other: Placebo
Sugar pill




Primary Outcome Measures :
  1. Pain reporting accuracy [ Time Frame: Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes. ]
    Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable".

  2. Change in experimental pain perception due to placebo pill intake [ Time Frame: Tonic stimuli before the placebo (Pre-placebo) until receiving the same stimuli 20 minutes after taking the placebo pill (Post-placebo). ]
    Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable". The placebo effect (Δ) will be calculated as the difference between the mean NPS.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • absence of acute or chronic pain disorders;
  • no reports of psychiatric, cognitive and /or neurological disorders;
  • no drugs including, analgesics or anti-anxiety medications on regular use (except for oral contraceptives).

Exclusion Criteria:

  • pregnant or breast-feeding;
  • unable to give informed consent, communicate and understand the purpose and the instructions of the study.

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): NCT03950999


Contacts
Layout table for location contacts
Contact: Roi Treister, PhD 972-(0)4-6146214 treister.roi@gmail.com
Contact: Liat Honigman, PhD 972-(0)4-6146214 taliathonigman@gmail.com

Locations
Layout table for location information
Israel
University of Haifa, The Clinical Pain Innovation Lab Recruiting
Haifa, Israel, 3498838
Contact: Roi Treister, PhD    972-(0)4-6146214    treister.roi@gmail.com   
Sponsors and Collaborators
University of Haifa

Layout table for additonal information
Responsible Party: Roi Treister, Head of The Clinical Pain Innovation Lab, University of Haifa
ClinicalTrials.gov Identifier: NCT03950999     History of Changes
Other Study ID Numbers: 273/17
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roi Treister, University of Haifa:
Focus analgesia selection test (FAST)
Placebo effect
Experimental pain variability