NCT00677157

Completed

Evaluation and Diagnosis of People With Pain and Fatigue Syn...

National Institute of Nursing Research (NINR)Source

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Other study identifiers

Sponsor study identifier

080132

Secondary identifiers

08-NR-0132

Study Type

observational

Actual enrollment (reported)

367

Locations

1 country

Sites

1

Timeline

Study Start

May 23, 2008

Actual (reported)

Primary Completion

September 17, 2020

Actual (reported)

Study Completion

September 17, 2020

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 367 participants
Study completion date: September 17, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 9, 2008
Actual (reported)
First Posted
May 13, 2008
Actual (reported)
Study Start
May 23, 2008
Actual (reported)
Primary Completion
September 17, 2020
Actual (reported)
Study Completion
September 17, 2020
Actual (reported)

Last Updated: September 22, 2020
Status Verified: September 2020
Last Update Submitted: September 21, 2020

Conditions

Fatigue

Keywords

FatigueFibromyalgiaPainComplex Regional Pain SyndromeReflex Sympathetic Dystrophy

Outcome Measures

Primary Outcomes (1)

Eligibility for participation in NINR study
Qualification for an active NINR study.
screening visit

Study Arms (1)

screening

participants evaluated for possible inclusion in a natural history or intervention protocol

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

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

You may qualify if:

To be included, patients must meet all of the following:

Sponsors & Collaborators

National Institute of Nursing Research (NINR)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

MeSH Terms

Conditions

FatigueFibromyalgiaPainComplex Regional Pain SyndromesReflex Sympathetic Dystrophy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsAutonomic Nervous System DiseasesPeripheral Nervous System Diseases

Study Officials

Leorey N Saligan, C.R.N.P.
National Institute of Nursing Research (NINR)
PRINCIPAL INVESTIGATOR

Enrollment

367 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 13, 2008

Study Start

May 23, 2008

Actual (reported)

Primary Completion

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Are greater than or equal to 18 years of age;

Have symptoms of pain and/or fatigue.

You may not qualify if:

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
+6 more criteria

Contact the study team to confirm eligibility.

September 17, 2020

Actual (reported)

Study Completion

September 17, 2020

Actual (reported)

Last Updated

September 22, 2020

Record last verified: 2020-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00677157
Data provider: ClinicalTrials.gov
Source updated: 2020-09-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:12 UTC

Locations

US(1)

Evaluation and Diagnosis of People With Pain and Fatigue Syndromes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

screening

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

screening

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations