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Evaluation and Diagnosis of People With Pain and Fatigue Syndromes - NCT00677157-20892(Clinical Trial 220434)



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City:  Bethesda
State:  
MD
Zip Code: 20892
Conditions: Fatigue - Fibromyalgia - Pain - Complex Regional Pain Syndrome - Reflex Sympathetic Dystrophy
Purpose: 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.
Study summary: 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. 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 by doing strength tests (i.e. hand grips), walk tests (6-minute walk test), physical activity monitoring (portable activity monitor), and exercise test. 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.
Criteria: - 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.
Study is available at: National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States

Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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