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Clinical and Scientific Assessment of Pain and Painful Disorders

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ClinicalTrials.gov Identifier: NCT02707029
Recruitment Status : Recruiting
First Posted : March 14, 2016
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) )

Tracking Information
First Submitted Date March 8, 2016
First Posted Date March 14, 2016
Last Update Posted Date September 16, 2019
Actual Study Start Date July 22, 2016
Estimated Primary Completion Date February 9, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2019)
To enable for the deep, broad, and targeted phenotyping of individuals, in particular those with rare and unusual pain disorders. [ Time Frame: 36 months ]
Data are to be collected via medical history, physical examinations, questionnaires, laboratory samples and MRI imaging.
Original Primary Outcome Measures
 (submitted: March 9, 2016)
To enable for the deep, broad, and targeted phenotyping of individuals, in particular those with rare and unusual pain disorders. [ Time Frame: On-going ]
Change History Complete list of historical versions of study NCT02707029 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 4, 2019)
To facilitate obtaining information relevant to determining potential eligibility in IRB-approved NIH protocols, in particular those of the Clinical Investigations Branch of NCCIH. [ Time Frame: 36 months ]
Data are to be collected via medical history, physical examinations, questionnaires, laboratory samples and MRI imaging.
Original Secondary Outcome Measures
 (submitted: March 9, 2016)
To facilitate obtaining information relevant to determining potential eligibility in IRB-approved NIH protocols, in particular those of the Clinical Investigations Branch of NCCIH. [ Time Frame: On-going ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical and Scientific Assessment of Pain and Painful Disorders
Official Title Clinical and Scientific Assessment of Pain and Painful Disorders
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.

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 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 (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 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with or without pain disorders.
Condition
  • Normal Physiology
  • Pain
Intervention Not Provided
Study Groups/Cohorts Persons, with or without pain disorders
Adults and adolescents with or without pain disorders.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 9, 2016)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 9, 2026
Estimated Primary Completion Date February 9, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • 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.
  • Pregnant Women
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Adebisi O Ayodele, C.R.N.P. (301) 827-0415 bisi.ayodele@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02707029
Other Study ID Numbers 160077
16-AT-0077
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) )
Study Sponsor National Center for Complementary and Integrative Health (NCCIH)
Collaborators Not Provided
Investigators
Principal Investigator: Mary C Bushnell, Ph.D. National Center for Complementary and Integrative Health (NCCIH)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 11, 2019