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| Sponsor: | National Institute of Nursing Research (NINR) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00677157 |
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:
| Condition |
|---|
|
Fatigue Fibromyalgia Pain Complex Regional Pain Syndrome Reflex Sympathetic Dystrophy |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Evaluation and Diagnosis of Potential Research Subjects With Pain and Fatigue Syndromes |
| Estimated Enrollment: | 1000 |
| Study Start Date: | May 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
To be included, patients must meet all of the following:
EXCLUSION CRITERIA:
Patients with any one of the following will be excluded:
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact | |
More Information
| ClinicalTrials.gov Identifier: | NCT00677157 History of Changes |
| Other Study ID Numbers: | 080132, 08-NR-0132 |
| Study First Received: | May 9, 2008 |
| Last Updated: | December 23, 2011 |
| Health Authority: | United States: Federal Government |
|
Fatigue Fibromyalgia Pain Complex Regional Pain Syndrome |
Reflex Sympathetic Dystrophy CPRS RSD |
|
Fatigue Fibromyalgia Myofascial Pain Syndromes Reflex Sympathetic Dystrophy Somatoform Disorders Complex Regional Pain Syndromes Signs and Symptoms Muscular Diseases |
Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Autonomic Nervous System Diseases Peripheral Nervous System Diseases Mental Disorders |