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

ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

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 test

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

Treatment groups

59 Participants
are divided into 2 treatment groups
Group A: chronic widespread pain1 intervention
Group B: Fibromyalgia1 intervention

Trial outcomes

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.

Time frame
up to 1 week

Secondary outcomes

1

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

Time frame
up to 1 week
2

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.

Time frame
up to 1 week
3

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.

Time frame
up to 1 week
4

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

Time frame
up to 1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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