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Evaluation and Diagnosis of People With Pain and Fatigue Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00677157
Recruitment Status : Recruiting
First Posted : May 13, 2008
Last Update Posted : November 22, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )

Brief Summary:

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.

Condition or disease
Fatigue Fibromyalgia Pain Complex Regional Pain Syndrome Reflex Sympathetic Dystrophy

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 1000 participants
Time Perspective: Prospective
Official Title: Evaluation and Diagnosis of Potential Research Subjects With Pain and Fatigue Syndromes
Study Start Date : May 8, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Primary Outcome Measures :
  1. Eligibility for participation in NINR study [ Time Frame: Ongoing ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00677157

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Contact: Leorey N Saligan, C.R.N.P. (301) 451-1685

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
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Principal Investigator: Leorey N Saligan, C.R.N.P. National Institute of Nursing Research (NINR)

Additional Information:
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Responsible Party: National Institute of Nursing Research (NINR) Identifier: NCT00677157     History of Changes
Other Study ID Numbers: 080132
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 15, 2018
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) ):
Complex Regional Pain Syndrome
Reflex Sympathetic Dystrophy
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Myofascial Pain Syndromes
Pathologic Processes
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases