Clinical trial NCT03381131: Chinese Version of Fibromyalgia Criteria and Severity Scales Study
Official title: The Chinese Version of the Modified American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia and the Fibromyalgia Impact Questionnaire: Reliability and Validity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chinese Version
Fibromyalgia
Diagnosis
Fibromyalgia Impact Questionnaire
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: the Chinese Version of Fibromyalgia Impact Questionnaire (FIQ-C)
timeFrame: up to 1 week
Secondary outcomes:
measure: Widespread pain index (WPI)
timeFrame: up to 1 week
measure: Symptom severity scale (SSS)
timeFrame: up to 1 week
measure: the polysymptomatic distress (PSD) scale
timeFrame: up to 1 week
measure: the Chinese Version of the Revised Fibromyalgia Impact Questionnaire (FIQR-C)
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
References:
citation: 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.