NCT00914173

Brief Summary

The clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. The efficacy of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Nov 2008

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

November 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 28, 2010

Status Verified

January 1, 2010

Enrollment Period

11 months

First QC Date

June 3, 2009

Last Update Submit

January 27, 2010

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Comparison between the pain monitoring device results and the subjective pain report measured by the numeric pain scale to a given pain stimulus (heat and cold)

    one year

Secondary Outcomes (1)

  • Collect database to implement the algorithm for the pain monitor to differ between different pain levels.

    one year

Study Arms (1)

Pain/No Pain Stimuli

EXPERIMENTAL

One Arm is used in this trial. The comparator is within the arm. The different types of stimuli levels and types are compared.

Device: Scanlaf Circulator and water bathDevice: Medoc TSA 2000

Interventions

Scanlaf Circulator and water bathDEVICE

Cold Pressor Test

Also known as: Open Cold Water Bath
Pain/No Pain Stimuli
Medoc TSA 2000DEVICE

Thermal stimuli pain

Also known as: Medoc Advanced Medical Systems TSA-II System
Pain/No Pain Stimuli

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy participant that response to pain stimuli
  • Blood Pressure \< (90,140), Heart Rate \< 100pps
  • Patient informed consent must be obtained

You may not qualify if:

  • Not responding to pain stimuli (Hypoalgesia)
  • Over responding to pain stimuli (Hyperalgesia)
  • Classifying non pain stimuli as painful event (Allodynia)
  • Medication/drugs were taken in the last week
  • Usage of chronic medication in the last 3 months (not including contraceptive pills)
  • Alcohol usage during the last 48 hours
  • Caffeine in the last 3 hours
  • Pregnant women
  • Inability to comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Relief Unit,Rambam Medical Center

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elon Eisenberg, Prof.

    Pain Relief Unit, Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 4, 2009

Study Start

November 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 28, 2010

Record last verified: 2010-01

Locations

IL(1)