ClinicalTrials.gg
Not yet recruitingNCT07712874Updated Nov 10, 2026

Screening Protocol

An observational study in Pain, sponsored by National Center for Complementary and Integrative Health (NCCIH). Not yet recruiting at 1 site in United States. Open to participants aged 12 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

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

Updated Nov 10, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
10,000
Ages
12 Years to 100 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pain

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Keywords

  • Pain screening
  • Healthy Volunteers
  • Quantitative Sensory Testing
  • Ecological Momentary Assessment
  • Patient-Reported Outcomes
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 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

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

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 form.

Exclusion criteria

EXCLUSION CRITERIA:

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).

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
10,000 participants (estimated)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 3 days

Secondary outcomes

  1. Patient-reported pain and symptom measures

    Standardized questionnaires assessing pain and related symptoms.

    Time frame: Up to 3 days

  2. Quantitative sensory testing measures

    Standardized sensory testing assessing pain-related and sensory responses.

    Time frame: Up to 3 days

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    • NIH Clinical Center Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

32 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Nov 2026; primary completion for Jul 2050, 283 months later.

Start moved 32 times since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 10, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2026
First posted
Jul 20, 2026
StartEst.
Nov 15, 2026was Sep 2026
Primary completionEst.
Jul 2, 2050
CompletionEst.
Jul 2, 2050
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 29, 2026→Nov 15, 2026
moved 32 times, Sep 25, 2026 – Nov 10, 2026
Show all 32 updates
  1. Nov 10, 2026
    Start date Nov 12, 2026→Nov 15, 2026
  2. Nov 9, 2026
    Start date Nov 11, 2026→Nov 12, 2026
  3. Nov 6, 2026
    Start date Nov 10, 2026→Nov 11, 2026
  4. Nov 5, 2026
    Start date Nov 9, 2026→Nov 10, 2026
  5. Nov 4, 2026
    Start date Nov 8, 2026→Nov 9, 2026
  6. Nov 3, 2026
    Start date Nov 5, 2026→Nov 8, 2026
  7. Nov 2, 2026
    Start date Nov 4, 2026→Nov 5, 2026
  8. Oct 30, 2026
    Start date Nov 3, 2026→Nov 4, 2026
  9. Oct 29, 2026
    Start date Nov 2, 2026→Nov 3, 2026
  10. Oct 28, 2026
    Start date Nov 1, 2026→Nov 2, 2026
  11. Oct 27, 2026
    Start date Oct 29, 2026→Nov 1, 2026
  12. Oct 26, 2026
    Start date Oct 28, 2026→Oct 29, 2026
  13. Oct 23, 2026
    Start date Oct 27, 2026→Oct 28, 2026
  14. Oct 22, 2026
    Start date Oct 26, 2026→Oct 27, 2026
  15. Oct 21, 2026
    Start date Oct 25, 2026→Oct 26, 2026
  16. Oct 20, 2026
    Start date Oct 22, 2026→Oct 25, 2026
  17. Oct 19, 2026
    Start date Oct 21, 2026→Oct 22, 2026
  18. Oct 16, 2026
    Start date Oct 20, 2026→Oct 21, 2026
  19. Oct 15, 2026
    Start date Oct 19, 2026→Oct 20, 2026
  20. Oct 14, 2026
    Start date Oct 18, 2026→Oct 19, 2026
  21. Oct 13, 2026
    Start date Oct 14, 2026→Oct 18, 2026
  22. Oct 9, 2026
    Start date Oct 13, 2026→Oct 14, 2026
  23. Oct 8, 2026
    Start date Oct 12, 2026→Oct 13, 2026
    + 1 other change: verification date
  24. Oct 7, 2026
    Start date Oct 11, 2026→Oct 12, 2026
  25. Oct 6, 2026
    Start date Oct 8, 2026→Oct 11, 2026
  26. Oct 5, 2026
    Start date Oct 7, 2026→Oct 8, 2026
  27. Oct 2, 2026
    Start date Oct 6, 2026→Oct 7, 2026
  28. Oct 1, 2026
    Start date Oct 5, 2026→Oct 6, 2026
  29. Sep 30, 2026
    Start date Oct 4, 2026→Oct 5, 2026
  30. Sep 29, 2026
    Start date Oct 1, 2026→Oct 4, 2026
  31. Sep 28, 2026
    Start date Sep 30, 2026→Oct 1, 2026
  32. Sep 25, 2026
    Start date Sep 29, 2026→Sep 30, 2026

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
NCT07712874
Responsible party
Sponsor
First posted
Jul 20, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Jul 2, 2050 (estimated)
Completion
Jul 2, 2050 (estimated)
Last update
Nov 10, 2026

Study contacts

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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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