FatigueNCT00677157
Evaluation and Diagnosis of People With Pain and Fatigue Syndromes
An observational study of Fatigue, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue
- How many people
- 367 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2008to 17 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants for this study will be recruited from a population of patients with pain and fatigue symptoms from other institutes and from referrals from outside centers
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation and Diagnosis of Potential Research Subjects With Pain and Fatigue Syndromes
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.
Read the 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.
- Conditions
- Fatigue
- Keywords
- Fatigue, Fibromyalgia, Pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy
- Medical subject headings
- Fatigue, Fibromyalgia, Pain, Complex Regional Pain Syndromes, Reflex Sympathetic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| screening | participants evaluated for possible inclusion in a natural history or intervention protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility for participation in NINR study
Qualification for an active NINR study.
Measured: screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study start23 May 2008
- Primary completion17 Sep 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Leorey N Saligan, C.R.N.P., Principal investigator, National Institute of Nursing Research (NINR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677157
- Sponsor's protocol ID
- 080132
- Other IDs
- 08-NR-0132
- Status last verified
- Sep 2020
- First submitted
- 9 May 2008
- Last updated
- 22 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Diagnosis of Potential Research Subjects With Pain and Fatigue Syndromes
- ClinicalTrials.gov ID
- NCT00677157
- Acronym / sponsor ID
- 080132
- Conditions
- Fatigue
- Keywords
- Fatigue, Fibromyalgia, Pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 23 May 2008 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screening | – | –participants evaluated for possible inclusion in a natural history or intervention protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants for this study will be recruited from a population of patients with pain and fatigue symptoms from other institutes and from referrals from outside centers
Key inclusion criteria (3 listed)
- Are greater than or equal to 18 years of age;
- Have symptoms of pain and/or fatigue.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eligibility for participation in NINR study
Time frame: screening visit
Qualification for an active NINR study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Fatigue
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Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
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Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
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Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
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Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leorey N Saligan, C.R.N.P. principal investigator
National Institute of Nursing Research (NINR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility for participation in NINR study (time frame: screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.