An observational study in Chinese Version, Fibromyalgia and Diagnosis, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-01-25.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Observational
Among 10 studies in Fibromyalgia by Guang'anmen Hospital of China Academy of Chinese Medical Sciences — 2 open to participants now, 2 under way, none of them phase 3. Fibromyalgia · Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Among the 10 studies in Fibromyalgia by Guang'anmen Hospital of China Academy of Chinese Medical Sciences, this one is one of 2 that started in 2018, is one of 3 observational ones, and was the 3rd registered.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's enrollment of 327 is above the median of 100 across 279 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →2 of the 10 studies in Fibromyalgia by Guang'anmen Hospital of China Academy of Chinese Medical Sciences are open now, in 1 country. Each count lists the studies.
Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2018.
Median enrollment 60 across the 7 interventional studies, 124 across the 3 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 137 studies on the registry; 37 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Fibromyalgia by Guang'anmen Hospital of China Academy of Chinese Medical Sciences, from their registry updates:
Nothing recorded among them since 2026-09-25.
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).
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: up to 1 week
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.
Time frame: up to 1 week
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.
Time frame: up to 1 week
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.
Time frame: up to 1 week
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.
Time frame: up to 1 week
Ran from Oct 2018 to primary completion in Dec 2021, 38 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences →