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Evaluation and Diagnosis of People With Pain and Fatigue Syndromes
This study is currently recruiting participants.
Verified March 2011 by National Institutes of Health Clinical Center (CC)

First Received on May 9, 2008.   Last Updated on December 23, 2011   History of Changes
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:

  • 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):

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

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
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            
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
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

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:
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

ClinicalTrials.gov processed this record on February 09, 2012