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Using the Chinese Indigenization FS Scale in the Diagnosis of Fibromyalgia: Specificity and Sensitivity in Clinical Practice

Using the Chinese Indigenization FS Scale in the Diagnosis of Fibromyalgia: Specificity and Sensitivity in Clinical Practice

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06533410
Enrollment
59
Registered
2024-08-01
Start date
2024-05-21
Completion date
2025-05-31
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

This study aimed to evaluate the specificity and sensitivity of the diagnostic criteria for fibromyalgia after conducting local validation in China.

Interventions

DIAGNOSTIC_TESTThe FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that

The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that

Sponsors

Hebei Provincial Hospital of Traditional Chinese Medicine
CollaboratorOTHER_GOV
BAODING NO.1 HOSPITAL OF TCM
CollaboratorUNKNOWN
Inner Mongolia Hospital of Traditional Chinese Medicine
CollaboratorUNKNOWN
Shenzhen Hospital of Traditional Chinese Medicine
CollaboratorUNKNOWN
Suzhou Hospital of Traditional Chinese Medicine
CollaboratorOTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* At least 18 years of age; Patients with chronic widespread pain; Able to complete the questionnaire.

Exclusion criteria

* Terminal patients with severe psychiatric diseases, tumors, systemic lupus erythematosus, systemic sclerosis, or other serious diseases.

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of fibromyalgia with the Polysymptomatic Distress Scale(PDS)up to 1 weekThe 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

MeasureTime frameDescription
Fibromyalgia symptoms severity as measured by the Rebised Fibromyalgia Impact Questionnaire(FIQR)up to 1 weekThe 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)up to 1 weekThe 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.
QOL as measured by Short Form-36 Health Status Questionnaire(SF-36)up to 1 weekThe 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
Sleep scores as measured by Pittsburgh sleep quality index(PSQI)up to 1 weekScores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Fatigue was measured by the Multidimensional Fatigue Inventory(MFI-20)up to 1 weekThe Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Stress scores as measured by Perceived Stress Scale(PSS)up to 1 weekThe 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026