View Clinical Trial (Medical Research Study)
Evaluation and Diagnosis of Potential Research Subjects With Pain and Fatigue Syndromes
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Fatigue - Fibromyalgia - Pain - Complex Regional Pain Syndrome - Reflex Sympathetic Dystrophy |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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- 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
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| NCT ID: |
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NCT00677157 |
| Primary Contact: |
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Principal Investigator
Leorey N Saligan, C.R.N.P.
National Institute of Nursing Research (NINR)
Leorey N Saligan, C.R.N.P.
Phone: (301) 451-1685
Email: saliganl@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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