Fatigue Clinical Trial
Official title:
Evaluation and Diagnosis of Potential Research Subjects With Pain and Fatigue Syndromes
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.
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.
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