About this trial
This study aimed to evaluate the specificity and sensitivity of the diagnostic criteria for fibromyalgia after conducting local validation in China.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age; Patients with chronic widespread pain; Able to complete the questionnaire.
Disqualifiers
Terminal patients with severe psychiatric diseases, tumors, systemic lupus erythematosus, systemic sclerosis, or other serious diseases.
Trial population
chronic widespread pain: pain on the left side of the body, pain on the right side, pain above the waist, and pain below the waist. In addition, axial bone pain (cervical or anterior chest or thoracic or lower back pain) must be present. In this definition, shoulder and hip pain are considered pain on each affected side. "Lower back pain" is thought to be lower pain.)
Trial design
Cohort
Prospective
Treatments tested in this trial
The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that
Diagnostic testThe FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that
Treatment groups
Trial outcomes
Primary outcomes
Diagnosis of fibromyalgia with the Polysymptomatic Distress Scale(PDS)
The PDS 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.
Secondary outcomes
QOL as measured by Short Form-36 Health Status Questionnaire(SF-36)
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status
Fibromyalgia symptoms severity as measured by the Rebised Fibromyalgia Impact Questionnaire(FIQR)
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.
Depression scores as measured by Beck depression inventory(BDI)
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Stress scores as measured by Perceived Stress Scale(PSS)
The Perceived Stress Scale (PSS) is for measuring the perception of stress and The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity
Sponsors and contacts
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead sponsor
Hebei Provincial Hospital of Traditional Chinese Medicine
Collaborator
BAODING NO.1 HOSPITAL OF TCM
Collaborator
Inner Mongolia Hospital of Traditional Chinese Medicine
Collaborator
Shenzhen Hospital of Traditional Chinese Medicine
Collaborator
Suzhou Hospital of Traditional Chinese Medicine
Collaborator