Screening Protocol

NCT07712874 | Not Yet Recruiting

• 2 other identifiers: 10002552002552-AT
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Pain screening; Healthy Volunteers; Quantitative Sensory Testing; Ecological Momentary Assessment; Patient-Reported Outcomes

Outcome Measures

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.

  Up to 3 days

Secondary Outcomes (2)

• Patient-reported pain and symptom measures

  Up to 3 days

• Quantitative sensory testing measures

  Up to 3 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miroslav Backonja, M.D.

  National Center for Complementary and Integrative Health (NCCIH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miroslav Backonja, M.D.

CONTACT

(301) 402-5679; misha.backonja@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): July 2, 2050
• Study Completion (Estimated): July 2, 2050
• Last Updated: July 31, 2026

Record last verified: 2026-07-14

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)