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Evaluation and Diagnosis of People With Pain and Fatigue Syndromes

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier:
NCT00677157
First received: May 9, 2008
Last updated: November 11, 2014
Last verified: January 2014
  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.

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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To facilitate patient recruitment to National Institute of Nursing Research (NINR) clinical research studies on chronic pain and fatigue syndromes.

Estimated Enrollment: 1000
Study Start Date: May 2008
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 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:   Yes
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677157

Contacts
Contact: Leorey N Saligan, C.R.N.P. (301) 451-1685 saliganl@mail.nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Leorey N Saligan, C.R.N.P. National Institute of Nursing Research (NINR)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier: NCT00677157     History of Changes
Other Study ID Numbers: 080132, 08-NR-0132
Study First Received: May 9, 2008
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Fatigue
Fibromyalgia
Pain
Complex Regional Pain Syndrome
Reflex Sympathetic Dystrophy
CPRS
RSD

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Fatigue
Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Autonomic Nervous System Diseases
Disease
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014