Fibromyalgia Clinical Trial
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
NCT number | NCT03381131 |
Other study ID # | 83376 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | December 30, 2021 |
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).
Status | Completed |
Enrollment | 327 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Guang'anmen Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Widespread pain index (WPI) | WPI is the sum of number of areas (including both jaws, shoulder girdles, upper arms, lower arms, hips (buttocks, trochanters), upper legs and lower legs, as well as neck, shoulder girdle, upper back, lower back, chest and abdomen) in which the patient has had pain over the last week. Its score is between 0 and 19 with higher score indicating more severity. | up to 1 week | |
Secondary | Symptom severity scale (SSS) | The SSS score is the sum of the severity scores of the 3 symptoms (fatigue, waking unrefreshed, and cognitive symptoms) (0-9) plus the sum (0-3) of the number of the 3 symptoms (headaches, pain or cramps in lower abdomen and depression) the patient has been bothered by that occurred during the previous 6 months. Its range is from 0-12 with higher score indicating more severity. | up to 1 week | |
Secondary | the polysymptomatic distress (PSD) scale | The PSD scale fibromyalgia severity (FS) scale also known as the fibromyalgia severity (FS) scale. It is the sum of the WPI and SSS, and ranges is from 0-31 with higher score indicating more severity. | up to 1 week | |
Secondary | the Chinese Version of the Revised Fibromyalgia Impact Questionnaire (FIQR-C) | The FIQR has 21 individual questions and is divided into three linked sets of domains as the FIQ (that is, function, overall impact and symptoms). It differs from the FIQ in having modified function questions and the inclusion of questions on memory, tenderness, balance and environmental sensitivity. The total FIQR is the sum of the three modified domain scores which ranges is also from 0-100 with higher score indicating more sever symptoms. | up to 1 week |
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