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Protocol Details

Clinical and Scientific Assessment of Pain and Painful Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-AT-0077

Sponsoring Institute

National Center for Complementary and Integrative Health (NCCIH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 12 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses

Special Instructions

Currently Not Provided

Keywords

Screening Protocol;
Pain;
Phenotypes

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology;
Pain

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Center for Complementary and Integrative Health

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. 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.

Over the next 3 months, participants may have up to 4 other study visits. These last 2 to 4 hours each. They include repeats of some of the tests in the required visit.

Participants may be recorded at the visits.

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Eligibility

INCLUSION CRITERIA

-Are greater than or equal to 12 years of age

-Ability of subject or Legally Authorized Representative (LAR)/ legal guardian to understand, and the willingness to sign, a written informed consent document or provide assent.

EXCLUSION CRITERIA

-Have difficulties with communication that make subjective pain assessment impossible or unreliable.

-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.

-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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lauren Y. Atlas, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)



Monique B. Perry, M.D.
National Center for Complementary and Integrative Health (NCCIH)
BG 10-CRC RM 1-1416
10 CENTER DR
BETHESDA MD 20814
(301) 435-3768
Monique.perry2@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02707029

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