Evaluation and Diagnosis of People With Pain and Fatigue Syndromes

This screening protocol is designed to facilitate patient recruitment to the National
Institute of Nursing Research (NINR) clinical research studies on pain and fatigue syndromes.
This protocol will also validate the newly developed Saligan Fatigue Questionnaire. Patients
must meet the specific requirements of an IRB-approved research study; this protocol serves
as a first step for evaluating patients for possible inclusion in a natural history or
intervention protocol.

Candidates will be screened with medical history/physical examination, routine laboratory
tests, and questionnaires. The physical examination may include the standardized tender point
assessment as specified in the American College of Rheumatology (ACR) to diagnose
fibromyalgia, measurements of pain (allodynia, hyperalgesia, and hyperpathia), edema,
autonomic dysfunction (altered skin color, temperature, or sudomotor activity), and extent of
musculoskeletal dysfunction. It will also assess the patients level of pain, fatigue, and
quality of life by providing questionnaires for the patients to complete. When the screening
is completed, patients will be informed of their options to participate in other NINR
interventional or observational clinical research studies. Patients who are not eligible for
these studies will be informed of alternative treatments. No treatment is offered under this
protocol. Information collected in this protocol will be used to determine eligibility to
other NINR protocols.

- INCLUSION CRITERIA:

To be included, patients must meet all of the following:

- Are greater than or equal to 18 years of age;

- Have symptoms of pain and/or fatigue.

EXCLUSION CRITERIA:

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