Evaluation and Diagnosis of People With Pain and Fatigue Syndromes (NCT00677157) | Clinical Trial Compass
CompletedNot Applicable
Evaluation and Diagnosis of People With Pain and Fatigue Syndromes
United States367 participantsStarted 2008-05-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Eligibility for participation in NINR study
Timeframe: screening visit
Trial details
NCT IDNCT00677157
SponsorNational Institute of Nursing Research (NINR)