PainNCT07712874
Screening Protocol
An observational study of Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study is a screening evaluation for volunteers who are interested in participating in National Center for Complementary and Integrative Health (NCCIH) research studies about pain and related processes, such as emotion, mood, and decision-making. Read more about this study
- Who is it for?
- Ages 12 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 2 Jul 2050
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: No biospecimens will be retained for future use under this protocol. Blood and urine samples, if collected, are used only for screening or clinical testing and are not stored for future research.
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated interest in, and availability for, participating in NCCIH studies and willingness to comply with the procedures of this protocol.
- At least 12 years of age
- No identified acute health concerns (i.e. symptomatic uncontrolled diabetes mellitus, congestive heart failure, liver cirrhosis, ongoing cancer (excluding skin basal cell carcinoma and squamous cell carcinoma) as evidenced by screening medical history
- Ability to understand and able to provide written informed consent form.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Have active 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 active panic attacks.
- Ongoing substance uses disorder or illicit substance use
- Pregnancy
- Additional exclusion from optional QST procedures:
- Has a major medical condition or medical history that in a clinician's assessment could affect heat sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, or neurological conditions (including stroke and blindness or deafness, a history of brain damage, or psychosis).
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
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Screening Evaluation of Volunteers for Studies of Pain
This study is a screening evaluation for volunteers who are interested in participating in National Center for Complementary and Integrative Health (NCCIH) research studies about pain and related processes, such as emotion, mood, and decision-making. Screening may include review of medical history, physical exam, vital signs, questionnaires, blood and urine tests, and optional sensory testing to better understand pain and related symptoms. The purpose is to identify and characterize healthy volunteers and people with pain who may be eligible for future NCCIH research studies. This screening study does not test a treatment and has no formal hypothesis.
Read the detailed description
Study Description:
This protocol will serve as a volunteer screening protocol for intramural NCCIH. It will provide a vehicle for recruiting, examination, and preliminary testing of research volunteers for NCCIH studies.
Objectives:
To provide a centralized and standardized service for recruiting, screening, and characterizing volunteers interested to participate in studies of pain and related processes (e.g., emotion, affect, decision-making). Depending on their screening characteristics participants will then be offered opportunities to participate in one or more of the current studies of pain and related processes.
Endpoints:
While records of demographics are kept, there is no planned endpoint.
- Conditions
- Pain
- Keywords
- Pain screening, Healthy Volunteers, Quantitative Sensory Testing, Ecological Momentary Assessment, Patient-Reported Outcomes
- 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 |
|---|---|---|
| Healthy Volunteers | Individuals screened under this protocol who are determined to be in good health and without a pain history that would classify them as a participant with pain. These participants may be considered for future NCCIH studies as healthy controls. | |
| Participants With Pain | Individuals screened under this protocol who have a current or prior pain history or pain symptoms identified through medical history, examination, questionnaires, or sensory testing. These participants may be considered for future NCCIH studies of pain and related processes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening classification of participant health and pain status
Classification of participants as healthy volunteers or participants with pain based on screening history, exam, and protocol-specified assessments.
Measured: Up to 3 days
Secondary outcomes (2)
Patient-reported pain and symptom measures
Standardized questionnaires assessing pain and related symptoms.
Measured: Up to 3 days
Quantitative sensory testing measures
Standardized sensory testing assessing pain-related and sensory responses.
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start29 Oct 2026 (estimated)
- Primary completion2 Jul 2050 (estimated)
- Study completion2 Jul 2050 (estimated)
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.
- 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
- Other
- Time perspective
- Cross-sectional
- 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
- NCT07712874
- Sponsor's protocol ID
- 10002552
- Other IDs
- 002552-AT
- Status last verified
- 2 Oct 2026
- First submitted
- 16 Jul 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Evaluation of Volunteers for Studies of Pain
- ClinicalTrials.gov ID
- NCT07712874
- Acronym / sponsor ID
- 10002552
- Conditions
- Pain
- Keywords
- Pain screening, Healthy Volunteers, Quantitative Sensory Testing, Ecological Momentary Assessment, Patient-Reported Outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 2 Jul 2050 (estimated)
- Study completion
- 2 Jul 2050 (estimated)
- First posted
- 20 Jul 2026 (actual)
- 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 study is a screening evaluation for volunteers who are interested in participating in National Center for Complementary and Integrative Health (NCCIH) research studies about pain and related processes, such as emotion, mood, and decision-making. Screening may include review of medical history, physical exam, vital signs, questionnaires, blood and urine tests, and optional sensory testing to better understand pain and related symptoms. The purpose is to identify and characterize healthy volunteers and people with pain who may be eligible for future NCCIH research studies. This screening study does not test a treatment and has no formal hypothesis.
Detailed description
Study Description:
This protocol will serve as a volunteer screening protocol for intramural NCCIH. It will provide a vehicle for recruiting, examination, and preliminary testing of research volunteers for NCCIH studies.
Objectives:
To provide a centralized and standardized service for recruiting, screening, and characterizing volunteers interested to participate in studies of pain and related processes (e.g., emotion, affect, decision-making). Depending on their screening characteristics participants will then be offered opportunities to participate in one or more of the current studies of pain and related processes.
Endpoints:
While records of demographics are kept, there is no planned endpoint.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Individuals screened under this protocol who are determined to be in good health and without a pain history that would classify them as a participant with pain. These participants may be considered for future NCCIH studies as healthy controls. |
| Participants With Pain | – | –Individuals screened under this protocol who have a current or prior pain history or pain symptoms identified through medical history, examination, questionnaires, or sensory testing. These participants may be considered for future NCCIH studies of pain and related processes. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- No biospecimens will be retained for future use under this protocol. Blood and urine samples, if collected, are used only for screening or clinical testing and are not stored for future research.
Key inclusion criteria (5 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated interest in, and availability for, participating in NCCIH studies and willingness to comply with the procedures of this protocol.
- At least 12 years of age
- No identified acute health concerns (i.e. symptomatic uncontrolled diabetes mellitus, congestive heart failure, liver cirrhosis, ongoing cancer (excluding skin basal cell carcinoma and squamous cell carcinoma) as evidenced by screening medical history
- Ability to understand and able to provide written informed consent form.
Key exclusion criteria (6 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Have active 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 active panic attacks.
- Ongoing substance uses disorder or illicit substance use
- Pregnancy
- Has a major medical condition or medical history that in a clinician's assessment could affect heat sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, or neurological conditions (including stroke and blindness or deafness, a history of brain damage, or psychosis).
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
Screening classification of participant health and pain status
Time frame: Up to 3 days
Classification of participants as healthy volunteers or participants with pain based on screening history, exam, and protocol-specified assessments.
2 secondary outcomes
Patient-reported pain and symptom measures
Time frame: Up to 3 days
Quantitative sensory testing measures
Time frame: Up to 3 days
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 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 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 Miroslav Backonja, M.D. ((301) 402-5679, misha.backonja@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening classification of participant health and pain status (time frame: Up to 3 days). 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 26 Oct 2026.