Pain Clinical Trial
Official title:
Longitudinal Observational Pilot Study to Assess the Capabilities of an Experimental Device to Objectively Measure Pain.
| NCT number | NCT02036567 |
| Other study ID # | 28503 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2014 |
| Est. completion date | December 2017 |
| Verified date | September 2018 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - age 18-100 years Exclusion Criteria: - inability to sign consent |
| Country | Name | City | State |
|---|---|---|---|
| United States | Department of Anesthesia, Pain and Perioperative Medicine | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | correlation between pain as measured by the device and reported pain and clinical events, respectively | average 4 hours |
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