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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) )

Tracking Information
First Submitted Date May 9, 2008
First Posted Date May 13, 2008
Last Update Posted Date November 22, 2018
Study Start Date May 8, 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: November 18, 2015)
Eligibility for participation in NINR study [ Time Frame: Ongoing ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00677157 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Evaluation and Diagnosis of People With Pain and Fatigue Syndromes
Official Title Evaluation and Diagnosis of Potential Research Subjects With Pain and Fatigue Syndromes
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.
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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
  • Fatigue
  • Fibromyalgia
  • Pain
  • Complex Regional Pain Syndrome
  • Reflex Sympathetic Dystrophy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 5, 2009)
Original Enrollment
 (submitted: May 9, 2008)
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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.


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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Leorey N Saligan, C.R.N.P. (301) 451-1685
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00677157
Other Study ID Numbers 080132
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
Study Sponsor National Institute of Nursing Research (NINR)
Collaborators Not Provided
Principal Investigator: Leorey N Saligan, C.R.N.P. National Institute of Nursing Research (NINR)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date November 15, 2018