Normal PhysiologyNCT02707029
Clinical and Scientific Assessment of Pain and Painful Disorders
An observational study of Normal Physiology and Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology, Pain
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2016to 9 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with or without pain disorders.
Who may be able to join
- Are >= 12 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
- Conditions
- Normal Physiology, Pain
- Keywords
- Screening Protocol, Pain, Phenotypes
- 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 |
|---|---|---|
| Persons, with or without pain disorders | Adults and adolescents with or without pain disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study start22 Jul 2016
- Primary completion9 Feb 2027 (estimated)
- Study completion9 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Miroslav Backonja, M.D., Principal investigator, National Center for Complementary and Integrative Health (NCCIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707029
- Sponsor's protocol ID
- 160077
- Other IDs
- 16-AT-0077
- Status last verified
- 7 Oct 2026
- First submitted
- 8 Mar 2016
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will only share deidentified data with repositories or publications, as specified in the protocol.
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Scientific Assessment of Pain and Painful Disorders
- ClinicalTrials.gov ID
- NCT02707029
- Acronym / sponsor ID
- 160077
- Conditions
- Normal Physiology, Pain
- Keywords
- Screening Protocol, Pain, Phenotypes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 9 Feb 2027 (estimated)
- First posted
- 14 Mar 2016 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons, with or without pain disorders | – | –Adults and adolescents with or without pain disorders. |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with or without pain disorders.
Key inclusion criteria (1 listed)
- Are >= 12 years of age
Key exclusion criteria (5 listed)
- 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
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
To enable for the deep, broad, and targeted phenotyping of individuals, in particular those with rare and unusual pain disorders.
Time frame: 36 months
Data are to be collected via medical history, physical examinations, questionnaires, laboratory samples and MRI imaging.
1 secondary outcome
To facilitate obtaining information relevant to determining potential eligibility in IRB-approved NIH protocols, in particular those of the Clinical Investigations Branch of NCCIH.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 35189353Amir 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will only share deidentified data with repositories or publications, as specified in the protocol.
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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.
Miroslav Backonja, M.D. principal investigator
National Center for Complementary and Integrative Health (NCCIH)
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 Normal Physiology and Pain, run by National Center for Complementary and Integrative Health (NCCIH) 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 5 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keyonna L Berry ((301) 594-1782, keyonna.berry@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To enable for the deep, broad, and targeted phenotyping of individuals, in particular those with rare and unusual pain disorders. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707029, which also lists 1 linked publication.
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 13 Oct 2026.