Cross-sectional Study of Fibromyalgia

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT02449395
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-02
• Study First Submitted QC: 2015-05-16
• Study First Posted: 2015-05-20
• Primary Completion: 2016-03
• Study Completion: 2018-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ)	up to 1 week

Secondary Outcome Measures

Name	Time	Method
Stress scores as measured by Perceived Stress Scale (PSS)	up to 1 week
Fatigue scores as measured by Multidimensional Assessment Fatigue (MAF)	up to 1 week
Sleep scores as measured by Pittsburgh sleep quality index (PSQI)	up to 1 week
QOL as measured by Short Form-36 Health Status Questionnaire (SF-36)	up to 1 week
Pain scores as measured by Numerical rating scale (NRS)	up to 1 week
Depression scores as measured by Beck depression inventory (BDI)	up to 1 week

Trial Locations

Locations (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China