PainNCT02036567
Evaluation of Pain Measurement Device
An observational study of Pain, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women of all ethnicities will be included.
Who may be able to join
- age 18-100 years
Who cannot join
- inability to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Anesthesia, Pain and Perioperative Medicine
Stanford, California, 94305
About this study
Official title: Longitudinal Observational Pilot Study to Assess the Capabilities of an Experimental Device to Objectively Measure Pain.
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.
- Conditions
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between pain as measured by the device and reported pain and clinical events, respectively
Measured: average 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Zacharias Tzabazis, Stanford University
- Investigators
- Alexander Z Tzabazis, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036567
- Sponsor's protocol ID
- 28503
- Status last verified
- Sep 2018
- First submitted
- 8 Jan 2014
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Pilot Study to Assess the Capabilities of an Experimental Device to Objectively Measure Pain.
- ClinicalTrials.gov ID
- NCT02036567
- Acronym / sponsor ID
- 28503
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women of all ethnicities will be included.
Key inclusion criteria (1 listed)
- age 18-100 years
Key exclusion criteria (1 listed)
- inability to sign consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between pain as measured by the device and reported pain and clinical events, respectively
Time frame: average 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Z Tzabazis, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between pain as measured by the device and reported pain and clinical events, respectively (time frame: average 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.