Clinical and Scientific Assessment of Pain and Painful Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Healthy Studies |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 1/9/2019 |
| Start Date: | July 22, 2016 |
| End Date: | February 9, 2026 |
| Contact: | Adebisi O Ayodele, C.R.N.P. |
| Email: | bisi.ayodele@nih.gov |
| Phone: | (301) 827-0415 |
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.
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.
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 Laboratory of Clinical Investigation (LCI) 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 volunteers, in particular
those with pain disorders.
- To facilitate obtaining information relevant to determining potential eligibility of
consenting volunteers 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 (greater than
or equal to 12 years) that are willing to provide assent and/or consent may participate in
the study. This protocol is open to volunteers 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 and questionnaires.
Following the core evaluation, participants may undergo selected scientific measurements for
phenotyping purposes. Phenotyping measurements can occur over the course of several months.
On completion of the phenotyping measurements, participants will be discharged from the
protocol. After completion, past participants may be contacted to undergo re-evaluation as
appropriate.
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, psychophysical 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 volunteers, in
particular those with pain disorders. It will collect information on research volunteers
that, with consent, can be used to determine potential eligibility in other IRB-approved
protocols. The study will allow NCCIH investigators to perform descriptive research on pain
disorders for use in hypothesis generation.
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 Laboratory of Clinical Investigation (LCI) 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 volunteers, in particular
those with pain disorders.
- To facilitate obtaining information relevant to determining potential eligibility of
consenting volunteers 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 (greater than
or equal to 12 years) that are willing to provide assent and/or consent may participate in
the study. This protocol is open to volunteers 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 and questionnaires.
Following the core evaluation, participants may undergo selected scientific measurements for
phenotyping purposes. Phenotyping measurements can occur over the course of several months.
On completion of the phenotyping measurements, participants will be discharged from the
protocol. After completion, past participants may be contacted to undergo re-evaluation as
appropriate.
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, psychophysical 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 volunteers, in
particular those with pain disorders. It will collect information on research volunteers
that, with consent, can be used to determine potential eligibility in other IRB-approved
protocols. The study will allow NCCIH investigators to perform descriptive research on pain
disorders for use in hypothesis generation.
- INCLUSION CRITERIA
- Are greater than or equal to 12 years of age
- Are able to provide appropriate informed consent and/or informed assent as appropriate
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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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