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

NCT06533410 | Recruiting

• 1 other identifier: 2024-121-KY
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 1 week

Secondary Outcomes (6)

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

  up to 1 week

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

  up to 1 week

• Depression scores as measured by Beck depression inventory(BDI)

  up to 1 week

• Stress scores as measured by Perceived Stress Scale(PSS)

  up to 1 week

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

  up to 1 week

Study Arms (2)

chronic widespread pain

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

Fibromyalgia

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

Interventions

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

Fibromyalgia; chronic widespread pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 1, 2024
• Study Start: May 21, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)