Evaluation and Diagnosis of People With Pain and Fatigue Syndromes

Completed

Conditions studied: Fatigue

In brief

This study will examine people who have pain or fatigue symptoms with a known or unknown diagnosis to determine eligibility for other research studies. No treatment is offered under this protocol. People 18 years of age or older with symptoms of pain and fatigue may be eligible for this study. Participants undergo standard examinations needed to diagnose or evaluate their symptoms. The results of the test are used to screen subjects for possible participation in other Nursing Institute studies. The study requires from one to three visits at NIH over 12 months for procedures that may include the following: * Medical history, physical examination and questionnaires related to symptoms and quality of life. * Blood tests * Electrocardiogram * Tender point testing. Pressure is applied to areas of the shoulder, hip, neck, chest, elbow and knee to identify tenderness.

Key facts

Study ID

NCT00677157

Run by

National Institute of Nursing Research (NINR)

People needed

367

Starts

2008-05-23

Expected to finish

2020-09-17

Last updated by the study team

2020-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with any one of the following will be excluded:
• Inability to provide informed consent for the study;
• Are unwilling or unable to cooperate with the study procedures or travel to NIH for the procedures.
• In addition to the above criteria, participants with the following conditions will be excluded from the participating in the peak exercise testing:
• Pregnant or lactating women.
• Unable to refrain from smoking at least 4 hours prior to exercise testing sessions.
• Any medical condition that limits exercise performance and/or affects participants safety during exercise. This includes diseases of the cardiovascular, pulmonary, neurological, metabolic or musculoskeletal systems such as:
• Diagnosis or history of ischemic heart disease
• Dilated or hypertrophic cardiomyopathy
• Non-idiopathic cardiomyopathy
• Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg
• Diagnosis or history of right or left-sided heart failure or pulmonary hypertension
• Diagnosis or history of restrictive or obstructive lung disease
• Diagnosis or history of stroke
• Uncontrolled Type I or Type II Diabetes Mellitus
• Diagnosis of chronic liver disease, chronic kidney disease, acute kidney injury or acute liver failure
• Metastatic cancer active within the previous five years
• Mitochondrial disease
• On medications that would influence aerobic capacity or treadmill performance such as beta-blockers or antiretroviral therapy
• Active substance abuse including ETOH
• Medical or psychological instability such that subjects could not reasonably be expected to fulfill the study requirements

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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