NCT02036567

Brief Summary

This longitudinal observational study will attempt to objectively measure pain with an experimental, non-invasive device. Patients and volunteers will receive a baseline screening with psychophysical tests and questionnaires. Investigators will apply the device to measure pain during routine clinical care and correlate patients pain ratings and analgesia requirements to that measured by the device. A more standardized approach with experimental pain stimuli will be pursued in human volunteer studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

3.9 years

First QC Date

January 8, 2014

Last Update Submit

September 5, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • correlation between pain as measured by the device and reported pain and clinical events, respectively

    average 4 hours

Study Arms (3)

surgical patients

no interventions, observational study

laboring women

no interventions, observational study

volunteers

pain induction by noxious heat stimulation, measurement of pain by device and documentation of pain reported by subjects

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women of all ethnicities will be included.

You may qualify if:

  • age 18-100 years

You may not qualify if:

  • inability to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Pain and Perioperative Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Z Tzabazis, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 15, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 6, 2018

Record last verified: 2018-09

Locations

US(1)