The Chinese Version of the Modified American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia and the Fibromyalgia Impact Questionnaire: Reliability and Validity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 327
- Locations
- 1
- Primary Endpoint
- the Chinese Version of Fibromyalgia Impact Questionnaire (FIQ-C)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
the Chinese Version of Fibromyalgia Impact Questionnaire (FIQ-C)
Time Frame: up to 1 week
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.
Secondary Outcomes
- 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)
Investigators
Juan Jiao
Deputy chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
