Clinical and Scientific Assessment of Pain and Painful Disorders

Summary

Participation Requirements

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 p...

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 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. Some examples of patients to be studied include those with Sickle Cell disease, Fibrous Dysplasia, and patients with sensory loss, such as A-beta deafferentation or loss of PIEZO2 gene function. 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 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 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.

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