Chinese Version of Fibromyalgia Criteria and Severity Scales Study

NCT ID: NCT03381131

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 327 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-12-30

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).

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Without any psychiatric disorders other than depression.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Juan Jiao

Deputy chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guang'anmen Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37634058 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36261882 (View on PubMed)

Other Identifiers

83376

Identifier Type: -

Identifier Source: org_study_id