NCT03381131

Chinese Version of Fibromyalgia Criteria and Severity Scales Study

The Chinese Version of the Modified American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia and the Fibromyalgia Impact Questionnaire: Reliability and Validity

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 327 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Fibromyalgia is a chronic debilitating musculoskeletal pain syndrome that causes substantial physical and psychological impairments. The provisional criteria of the ACR 2010 and the 2011 self-report modification for survey and clinical research are widely used for fibromyalgia diagnosis. However, there is no Chinese version of fibromyalgia diagnosis criteria and severity assessment scales until now. The aim of this study is to investigate the reliability and the validity of the Chinese version of the 2011ModCr and 2016 ACR revisions to the 2011ModCr, as well as its quantification scale, the Chinese version of Fibromyalgia Impact Questionnaire (FIQ-C) and Revised FIQ (FIQR-C). In this study, we'll divide patients with chronic pain without psychiatric disorders other than depression into two groups according to the 1990 ACR diagnostic criteria for fibromyalgia, a fibromyalgia group and a non-fibromyalgia group. Patients in both groups will be assessed using the 2011ModCr and 2016 ACR revisions to the 2011ModCr. Furthermore, those in the fibromyalgia group will also complete FIQ-C, FIQR-C and several other validated questionnaires including the Medical Outcome Survey Short Form-36 (SF-36), the Beck Depression Inventory (BDI), ect.

Conditions

• Chinese Version
• Fibromyalgia
• Diagnosis
• Fibromyalgia Impact Questionnaire

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2017-12-21
• Last updated: 2022-01-25

Locations

1 site across 1 country: China