Cross-sectional Study of Fibromyalgia

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
      • Beijing, Beijing, China, 100053
        • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

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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