Chinese Version of Fibromyalgia Criteria and Severity Scales Study

Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03381131
Collaborator
(none)
327
1
39
8.4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 [Patient Registry]
    Actual Enrollment :
    327 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    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
    Actual Study Start Date :
    Oct 1, 2018
    Actual Primary Completion Date :
    Dec 30, 2021
    Actual Study Completion Date :
    Dec 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. the Chinese Version of Fibromyalgia Impact Questionnaire (FIQ-C) [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 Outcome Measures

    1. Widespread pain index (WPI) [up to 1 week]

      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.

    2. Symptom severity scale (SSS) [up to 1 week]

      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.

    3. the polysymptomatic distress (PSD) scale [up to 1 week]

      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.

    4. the Chinese Version of the Revised Fibromyalgia Impact Questionnaire (FIQR-C) [up to 1 week]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guang'anmen Hospital Beijing Beijing China 100053

    Sponsors and Collaborators

    • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Juan Jiao, Deputy chief physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03381131
    Other Study ID Numbers:
    • 83376
    First Posted:
    Dec 21, 2017
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 25, 2022