ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 133 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies

Chinese Version of Fibromyalgia Criteria and Severity Scales Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03381131
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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
Chinese Version Fibromyalgia Diagnosis Fibromyalgia Impact Questionnaire

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 Type : Observational [Patient Registry]
Estimated Enrollment : 590 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
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
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Widespread pain index (WPI) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381131


Locations
China, Beijing
Guang'anmen Hospital
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Responsible Party: Juan Jiao, Deputy chief physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03381131     History of Changes
Other Study ID Numbers: 83376
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases