Cross-sectional Study of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

A Cross-sectional Study of Fibromyalgia in Beijing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449395
• Other study ID #: 39301
• Status: Completed
• Start date: April 2015
• Est. completion date: March 2018

Study information

• Verified date: November 2018
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ)		up to 1 week
Secondary	QOL as measured by Short Form-36 Health Status Questionnaire (SF-36)		up to 1 week
Secondary	Pain scores as measured by Numerical rating scale (NRS)		up to 1 week
Secondary	Fatigue scores as measured by Multidimensional Assessment Fatigue (MAF)		up to 1 week
Secondary	Depression scores as measured by Beck depression inventory (BDI)		up to 1 week
Secondary	Stress scores as measured by Perceived Stress Scale (PSS)		up to 1 week
Secondary	Sleep scores as measured by Pittsburgh sleep quality index (PSQI)		up to 1 week