Ignite Creation Date:
2024-05-06 @ 8:16 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02707029
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2016-03-08
Brief Title:
Clinical and Scientific Assessment of Pain and Painful Disorders
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical and Scientific Assessment of Pain and Painful Disorders
Status:
RECRUITING
Status Verified Date:
2024-09-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 participants in particular those with pain disorders
To facilitate obtaining information relevant to determining potential eligibility of consenting participants 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 10000 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 andor consent may participate in the study This protocol is open to participants 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 LIP and questionnaires Following the core evaluation participants may undergo selected scientific measurements for phenotyping purposes Phenotyping measurements can occur over the course of several years On completion of the required and optional 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 participants in particular those with pain disorders It will collect information on research participants 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 participants in particular those with pain disorders
To facilitate obtaining information relevant to determining potential eligibility of consenting participants 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 10000 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 andor consent may participate in the study This protocol is open to participants 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 LIP and questionnaires Following the core evaluation participants may undergo selected scientific measurements for phenotyping purposes Phenotyping measurements can occur over the course of several years On completion of the required and optional 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 participants in particular those with pain disorders It will collect information on research participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 16-AT-0077 | None | None | None |