Chinese Version of Fibromyalgia Criteria and Severity Scales Study

NCT03381131 | Completed

• 1 other identifier: 83376
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

Up to now, there is no Chinese version of fibromyalgia diagnosis criteria and severity assessment scales. The aim of this study is to translate, adapt, and validate the Chinese version of the 2011 modification of the 2010 ACR preliminary criteria for the diagnosis of fibromyalgia (2011ModCr) and 2016 ACR revisions to the 2010/2011 fibromyalgia diagnostic criteria, as well as the Fibromyalgia Impact Questionnaire (FIQ-C).

Conditions

Chinese Version; Fibromyalgia; Diagnosis; Fibromyalgia Impact Questionnaire

Outcome Measures

Primary Outcomes (1)

• the Chinese Version of Fibromyalgia Impact Questionnaire (FIQ-C)

  This questionnaire was designed to assess the current health status of patients with fibromyalgia. The FIQ has 11 individual questions and measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week ranging from 0-100 with higher score indicating more severity.

  up to 1 week

Secondary Outcomes (4)

• Widespread pain index (WPI)

  up to 1 week

• Symptom severity scale (SSS)

  up to 1 week

• the polysymptomatic distress (PSD) scale

  up to 1 week

• the Chinese Version of the Revised Fibromyalgia Impact Questionnaire (FIQR-C)

  up to 1 week

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The fibromyalgia patients who meet the ACR 1990 criteria for diagnosis without psychiatric disorders other than depression will be recruited. During the study period, other patients with diseases associated with chronic pain, such as rheumatoid arthritis (RA), osteoarthritis (OA), and gout, who have not been diagnosed previously with fibromyalgia will be recruited as control patients. An experienced rheumatologist familiar with fibromyalgia assessed these patients.

You may qualify if:

• Age 18 years or older.
• Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for Fibromyalgia.

You may not qualify if:

• Without any psychiatric disorders other than depression.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (2)

• Jiao J, Cheng ZY, Xiao YY, Wang H, Zhang YF, Zhao YY, Jia Y. Validation of the 2011 and 2016 American college of rheumatology diagnostic criteria for fibromyalgia in a Chinese population. Ann Med. 2023;55(2):2249921. doi: 10.1080/07853890.2023.2249921.

  PMID: 37634058 DERIVED

• Li YT, Jiang Q, Jia Y, Zhang YF, Xiao YY, Wang H, Zhao YY, Jiao J. A Chinese version of the revised Fibromyalgia Impact Questionnaire: A validation study. Int J Rheum Dis. 2023 Feb;26(2):242-249. doi: 10.1111/1756-185X.14472. Epub 2022 Oct 19.

  PMID: 36261882 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Disease

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 21, 2017
• Study Start: October 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

CN (1)