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Protocol Details

Evaluation and Diagnosis of Potential Research Subjects with Pain and Fatigue Syndromes

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

08-NR-0132

Sponsoring Institute

National Institute of Nursing Research (NINR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Fatigue;
Fibromyalgia;
Pain;
Complex Regional Pain Syndrome;
Reflex Sympathetic Dystrophy

Recruitment Keyword(s)

Fatigue;
Fibromyalgia;
Complex Regional Pain Syndrome;
Reflex Sympathetic Dystrophy;
CPRS;
RSD;
Pain

Condition(s)

Fatigue;
Fibromyalgia;
Pain;
Complex Regional Pain Syndrome;
Reflex Sympathetic Dystrophy

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Nursing Research

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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Eligibility

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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Citations:

Al-Allaf AW. Work disability and health system utilization in patients with fibromyalgia syndrome. J Clin Rheumatol. 2007 Aug;13(4):199-201.

Bryan AS, Klenerman L, Bowsher D. The diagnosis of reflex sympathetic dystrophy using an algometer. J Bone Joint Surg Br. 1991 Jul;73(4):644-6.

Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders] Neurol Neurochir Pol. 2007 Jul-Aug;4 (4):340-9.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leorey N. Saligan, C.R.N.P.
National Institute of Nursing Research (NINR)
BG 3 RM 5E14
3 CENTER DR
BETHESDA MD 20814
(301) 451-1685
saliganl@mail.nih.gov

Leorey N. Saligan, C.R.N.P.
National Institute of Nursing Research (NINR)
BG 3 RM 5E14
3 CENTER DR
BETHESDA MD 20814
(301) 451-1685
saliganl@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00677157

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