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RecruitingNCT02707029Updated Oct 13, 2026

Clinical and Scientific Assessment of Pain and Painful Disorders

An observational study in Normal Physiology and Pain, sponsored by National Center for Complementary and Integrative Health (NCCIH). Recruiting at 1 site in United States. Open to participants aged 12 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Observational

From the registry’s dates

  • Started Jul 2016; still recruiting 10 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
12 Years to 120 Years
Sex
All
01

Study 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.

Read the detailed description

Objective:

The purpose of this study is to allow for the deep, broad, and targeted phenotyping of persons with or without pain disorders. This protocol will enable NCCIH investigators to describe the clinical aspects of pain disorders, collect scientific measurements for the purpose of making deep phenotypic descriptions, and use the collected data to perform descriptive analyses of pain disorders. The study will also facilitate obtaining information relevant to determining if a person is potentially eligible to participate in other research protocols at NIH, in particular those of the Office of the Clinical Director (OCD) at the National Center for Complementary and Integrative Health (NCCIH). The specific goals of this protocol are the following:

Research:

  • To enable the clinical description and phenotyping of research participants, in particular those with pain disorders.
  • To facilitate obtaining information relevant to determining potential eligibility of consenting participants to participate in other IRB-approved NIH protocols that focus on pain and related disorders.
  • To perform descriptive analyses of painful experiences within discrete pain disorders.

Study Population: The study population will consist of up to 10,000 persons with or without pain disorders, who seek to participate in research protocols at NIH, primarily those sponsored by NCCIH Division of Intramural Research investigators. Human beings of adolescence age or older (>= 12 years) that are willing to provide assent and/or consent may participate in the study. This protocol is open to participants of any ethnicity, gender, or nationality.

Design:

The protocol is designed as a cross-sectional observational study. Participants will initially undergo an informed consent process and a core phenotyping evaluation, which includes a clinical evaluation from a Licensed Independent Practitioner (LIP) and questionnaires. Following the core evaluation, participants may undergo selected scientific measurements for phenotyping purposes. Phenotyping measurements can occur over the course of several years.

Outcome Measures:

The study will use a wide variety of measurement tools for phenotyping purposes. These include, vital signs, medical history, physical exam, medical record review, qualitative pain interview, patient reported outcome measurements, psychological and behavioral measurements, clinical laboratory measurements, structural and functional imaging assessments using magnetic resonance imaging, and psychophysical measurements.

In summary, the NCCIH phenotyping protocol will enable investigators to obtain detailed clinical descriptions and collect phenotyping measurements from research participants, in particular those with pain disorders. It will collect information on research participants that, with consent, can be used to determine potential eligibility in other IRB-approved protocols and to support any further research and clinical decision making that would be based on this phenotyping information. The study will allow NCCIH investigators to perform descriptive research on pain disorders for use in hypothesis generation.

02

Conditions studied

  • Normal Physiology
  • Pain

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Keywords

  • Screening Protocol
  • Pain
  • Phenotypes
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 100 across 1,252 observational studies indexed under Pain.

Browse Pain studies →

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 223 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants with or without pain disorders.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Are >= 12 years of age

Exclusion criteria

EXCLUSION CRITERIA:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)

Groups and cohorts

  • Persons, with or without pain disorders

    Adults and adolescents with or without pain disorders.

06

What researchers measure

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.

    Time frame: 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.

    Data are to be collected via medical history, physical examinations, questionnaires, laboratory samples and MRI imaging.

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Publications

  • 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. PubMed 35189353 ↗

Individual participant data

Plan to share: No — We will only share deidentified data with repositories or publications, as specified in the protocol.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02707029
Responsible party
Sponsor
First posted
Mar 14, 2016
Start date
Jul 22, 2016
Primary completion
Feb 9, 2027 (estimated)
Completion
Feb 9, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Keyonna L Berry
Contact
keyonna.berry@nih.gov
(301) 594-1782
Miroslav Backonja, M.D.
Contact
misha.backonja@nih.gov
(301) 402-5679
Miroslav Backonja, M.D.
principal investigator · National Center for Complementary and Integrative Health (NCCIH)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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