Clinical and Scientific Assessment of Pain and Painful Disorders
2 other identifiers
observational
10,000
1 country
1
Brief Summary
Background: Researchers want to better understand pain by studying people with and without different kinds of pain. To do this, researchers will expose people to pleasant and unpleasant sensations. They will ask them questions about their pain. Researchers also want to see if these people are eligible for other research studies at the National Center for Complementary and Integrative Health. Objectives: To study the experience of pain. Also to find people eligible to join other NIH studies. Eligibility: People 12 years and older with and without pain disorders. Design: Participants will be screened by phone. Participants will have one required visit lasting about 2 hours. This may include:
- Medical history
- Physical exam
- Questionnaires about themselves and their pain experience
- Blood and urine tests
- MRI: They will lie on a table that slides into a cylinder. They will feel different sensations while completing tasks on a computer. This lasts 15 minutes to 2 hours.
- Quantitative sensory testing: They will be exposed to different pictures, sounds, tastes, and smells. They will also be exposed to pleasant and unpleasant sensations. These could include:
- Burning, itching, or cold sensations
- Pinpricks
- Pressure and pinches
- Electrocardiogram: Stickers on the chest record heart activity.
- Straps placed around the chest to measure breathing.
- Small sensors on the fingers or palms to measure pulse and sweating. Participants may have up to 12 other outpatient study visits. Participants may be recorded at the visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Longer than P75 for all trials
1 active site
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
First Submitted
Initial submission to the registry
March 8, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2016
CompletedStudy Start
First participant enrolled
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 9, 2027
May 1, 2026
April 24, 2026
10.6 years
March 8, 2016
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To enable for the deep, broad, and targeted phenotyping of individuals, in particular those with rare and unusual pain disorders.
Data are to be collected via medical history, physical examinations, questionnaires, laboratory samples and MRI imaging.
36 months
Secondary Outcomes (1)
To facilitate obtaining information relevant to determining potential eligibility in IRB-approved NIH protocols, in particular those of the Clinical Investigations Branch of NCCIH.
36 months
Study Arms (1)
Persons, with or without pain disorders
Adults and adolescents with or without pain disorders.
Eligibility Criteria
Participants with or without pain disorders.
You may qualify if:
- Are \>= 12 years of age
You may not qualify if:
- Have difficulties with communication that make subjective pain assessment impossible or unreliable.
- Have acute medical or psychiatric health issues that create additional and substantial adverse risks related to study procedures. Medical examples are the acute complications of medical disease, such as asymptomatic hypertensive urgency, diabetic ketoacidosis, symptomatic hyperthyroidism, and unstable angina. Psychiatric examples are the acute complications of psychiatric disease, such as acute mania, paranoid delusions, or having acute panic attacks.
- Are participating in other ongoing research protocols such that phenotypic measurements would interfere with the conduct of an ongoing protocols or the receipt of a research treatment would influence the phenotypic measurements.
- Employees or staff that work at NCCIH.
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (1)
Amir C, Rose-McCandlish M, Weger R, Dildine TC, Mischkowski D, Necka EA, Lee IS, Wager TD, Pine DS, Atlas LY. Test-Retest Reliability of an Adaptive Thermal Pain Calibration Procedure in Healthy Volunteers. J Pain. 2022 Sep;23(9):1543-1555. doi: 10.1016/j.jpain.2022.01.011. Epub 2022 Feb 19.
PMID: 35189353DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miroslav Backonja, M.D.
National Center for Complementary and Integrative Health (NCCIH)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2016
First Posted
March 14, 2016
Study Start
July 22, 2016
Primary Completion (Estimated)
February 9, 2027
Study Completion (Estimated)
February 9, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04-24
Data Sharing
- IPD Sharing
- Will not share
We will only share deidentified data with repositories or publications, as specified in the protocol.