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NCT Number: NCT06533410

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

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Diagnosis of fibromyalgia with the Polysymptomatic Distress Scale(PDS)

    Time frame: up to 1 week

    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

  1. QOL as measured by Short Form-36 Health Status Questionnaire(SF-36)

    Time frame: up to 1 week

    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

  2. Fibromyalgia symptoms severity as measured by the Rebised Fibromyalgia Impact Questionnaire(FIQR)

    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.

  3. Depression scores as measured by Beck depression inventory(BDI)

    Time frame: up to 1 week

    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.

  4. Stress scores as measured by Perceived Stress Scale(PSS)

    Time frame: up to 1 week

    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

  5. Sleep scores as measured by Pittsburgh sleep quality index(PSQI)

    Time frame: up to 1 week

    Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.

  6. Fatigue was measured by the Multidimensional Fatigue Inventory(MFI-20)

    Time frame: up to 1 week

    The 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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

  • BAODING NO.1 HOSPITAL OF TCM
  • Hebei Provincial Hospital of Traditional Chinese Medicine
  • Inner Mongolia Hospital of Traditional Chinese Medicine
  • Shenzhen Hospital of Traditional Chinese Medicine
  • Suzhou Hospital of Traditional Chinese Medicine

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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