Experimental Pain Reporting Accuracy and Placebo Response

NCT03950999 | Unknown

• 1 other identifier: 273/17
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Placebo Effect; Pain

Keywords

Focus analgesia selection test (FAST); Placebo effect; Experimental pain variability

Outcome Measures

Primary Outcomes (2)

• Pain reporting accuracy

  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".

  Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes.

• Change in experimental pain perception due to placebo pill intake

  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.

  Tonic stimuli before the placebo (Pre-placebo) until receiving the same stimuli 20 minutes after taking the placebo pill (Post-placebo).

Study Arms (1)

Study arm

EXPERIMENTAL

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

Interventions

Placebo OTHER

Sugar pill

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

University of Haifa, The Clinical Pain Innovation Lab

Haifa, 3498838, Israel

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roi Treister, PhD

CONTACT

972-(0)4-6146214; treister.roi@gmail.com

Liat Honigman, PhD

CONTACT

972-(0)4-6146214; taliathonigman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of The Clinical Pain Innovation Lab

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 15, 2019
• Study Start: August 13, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

IL (1)