- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02449395
Cross-sectional Study of Fibromyalgia
November 19, 2018 updated by: Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
A Cross-sectional Study of Fibromyalgia in Beijing
This study is designed to collect data on precipitating factors, diagnosis, morbidity, therapy, quality of life, and symptom severity, etc. informations in patients with fibromyalgia.
Study Overview
Status
Completed
Conditions
Detailed Description
Patients fulfilling 1990 ACR criterion for fibromyalgia will be recruited in Fibromyalgia outpatient service which is belonged to the Department of Rheumatism.
Except collecting patients' demographic and social characteristic informations, rheumatologist also carry out a comprehensive evaluation including patient current history, current medication use, and tender point examination for a diagnosis or confirmation of fibromyalgia and treatment recommendations.
Patients with fibromyalgia will be asked to fill a set of questionnaires to evaluate their quality of life, symptoms severity, quality of sleep and emotion.
The study will be conducted in Beijing, China.
Study Type
Observational
Enrollment (Actual)
124
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100053
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients fulfilling 1990 ACR criterion for fibromyalgia be seen in the Fibromyalgia Outpatient Service which belonged to the Department of Rheumatism, Guang'anmen Hospital, Beijing China.
Description
Inclusion Criteria:
- Age 18 years or older.
- Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for Fibromyalgia.
Exclusion Criteria:
- Don't fulfill any classification criterions for Fibromyalgia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: up to 1 week
|
up to 1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
QOL as measured by Short Form-36 Health Status Questionnaire (SF-36)
Time Frame: up to 1 week
|
up to 1 week
|
Pain scores as measured by Numerical rating scale (NRS)
Time Frame: up to 1 week
|
up to 1 week
|
Fatigue scores as measured by Multidimensional Assessment Fatigue (MAF)
Time Frame: up to 1 week
|
up to 1 week
|
Depression scores as measured by Beck depression inventory (BDI)
Time Frame: up to 1 week
|
up to 1 week
|
Stress scores as measured by Perceived Stress Scale (PSS)
Time Frame: up to 1 week
|
up to 1 week
|
Sleep scores as measured by Pittsburgh sleep quality index (PSQI)
Time Frame: up to 1 week
|
up to 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Juan Jiao, M.D.,PhD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
May 2, 2015
First Submitted That Met QC Criteria
May 16, 2015
First Posted (Estimate)
May 20, 2015
Study Record Updates
Last Update Posted (Actual)
November 20, 2018
Last Update Submitted That Met QC Criteria
November 19, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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