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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Diagnostic test: The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that

• Study Type: Observational
• Enrollment (Estimated): 59

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen Hospital
      • Contact: Juan Jiao, PhD; Phone Number: +8688001060; Email: jiao.juan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fibromyalgia	Diagnostic test: The 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
chronic widespread pain	Diagnostic test: The 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 1 week
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.	up to 1 week
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.	up to 1 week
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	up to 1 week
Sleep scores as measured by Pittsburgh sleep quality index(PSQI)	Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.	up to 1 week
Fatigue was measured by the Multidimensional Fatigue Inventory(MFI-20)	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.	up to 1 week

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Suzhou Hospital of Traditional Chinese Medicine; Hebei Provincial Hospital of Traditional Chinese Medicine; Shenzhen Hospital of Traditional Chinese Medicine; BAODING NO.1 HOSPITAL OF TCM; Inner Mongolia Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2024-121-KY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No