NCT03952715

Brief Summary

In previous studies, results of both the Focused Analgesia Selection Test (FAST) procedure, a method to assess pain-reporting accuracy, and the Evoked Pain Training (EPT) procedure, aimed to improve pain-reporting accuracy, correlated with the placebo response. The objectives of the current project were to determine if EPT (1) increases pain reporting accuracy and (2) affect the placebo response in experimental pain study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

May 15, 2019

Last Update Submit

May 15, 2019

Conditions

HealthyPlacebo Response

Keywords

Focus analgesia selection test (FAST)Experimental pain variabilityPlacebo effectEvoked pain training (EPT)

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 drug/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.

    Mechanical and thermal stimuli before the drug/placebo (Pre-drug/placebo) until receiving the same stimuli 40 minutes after taking the drug/placebo pill (Post-drug/placebo).

Secondary Outcomes (1)

  • Evoked pain training

    Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes. There are 3 training visits, each training consists of 2 FAST procedure and last approximately 1 hour.

Study Arms (2)

Evoked pain training

EXPERIMENTAL
Drug: Ibuprofen 400 mgDrug: Placebo oral tablet

Control

EXPERIMENTAL
Drug: Ibuprofen 400 mgDrug: Placebo oral tablet

Interventions

Ibuprofen 400 mgDRUG

Each subject will receive Ibuprofen once, in between two psycho-physical assessments. Between the drug intake and the second assessment the subject will have to wait for 40 minutes.

ControlEvoked pain training
Placebo oral tabletDRUG

Each subject will receive Placebo (sugar pill) once, in between two psycho-physical assessments. Between the placebo pill intake and the second assessment the subject will have to wait for 40 minutes.

ControlEvoked pain training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Absence of neurological, psychiatric, or chronic pain disorders.
  • Have used at list once Ibuprofen, and not sensitive to NSAIDs.
  • Ability to give informed consent, communicate, and understand the purpose and instructions of this study.

You may not qualify if:

  • Presence of diagnosed psychiatric disorders, cognitive and /or neurological deficits.
  • Use of analgesic, anti-depressant or anti-enxiayoltic medications on a regular basis (except for oral contraceptives).
  • Pregnancy.
  • Never used NSAIDs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa, The Clinical Pain Innovation Lab

Haifa, 3498838, Israel

RECRUITING

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

Roi Treister, PhD

CONTACT

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

Liat Honigman, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 16, 2019

Study Start

April 17, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

May 16, 2019

Record last verified: 2019-05

Locations

IL(1)