FibromyalgiaNCT06533410
Using the Chinese Indigenization FS Scale in the Diagnosis of Fibromyalgia： Specificity and Sensitivity in Clinical Practice
An observational study of Fibromyalgia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This study aimed to evaluate the specificity and sensitivity of the diagnostic criteria for fibromyalgia after conducting local validation in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.)
Who may be able to join
- At least 18 years of age; Patients with chronic widespread pain; Able to complete the questionnaire.
Who cannot join
- Terminal patients with severe psychiatric diseases, tumors, systemic lupus erythematosus, systemic sclerosis, or other serious diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital
Beijing, Beijing Municipality, 100053
Juan Jiao, PhD, +8688001060, jiao.juan@hotmail.com
About this study
This study aimed to evaluate the specificity and sensitivity of the diagnostic criteria for fibromyalgia after conducting local validation in China.
- Conditions
- Fibromyalgia
- Being tested
- The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond thatDiagnostic test
The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that
| Study group | Role | What they receive |
|---|---|---|
| chronic widespread pain | Not described Receives: Diagnostic Test: The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that | |
| Fibromyalgia | Not described Receives: Diagnostic Test: The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 week
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start21 May 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Provincial Hospital of Traditional Chinese Medicine, BAODING NO.1 HOSPITAL OF TCM, Inner Mongolia Hospital of Traditional Chinese Medicine, Shenzhen Hospital of Traditional Chinese Medicine, Suzhou Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533410
- Sponsor's protocol ID
- 2024-121-KY
- Status last verified
- Oct 2024
- First submitted
- 8 Jul 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Chinese Indigenization FS Scale in the Diagnosis of Fibromyalgia： Specificity and Sensitivity in Clinical Practice
- ClinicalTrials.gov ID
- NCT06533410
- Acronym / sponsor ID
- 2024-121-KY
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Hebei Provincial Hospital of Traditional Chinese Medicine, BAODING NO.1 HOSPITAL OF TCM, Inner Mongolia Hospital of Traditional Chinese Medicine, Shenzhen Hospital of Traditional Chinese Medicine, Suzhou Hospital of Traditional Chinese Medicine
- Study start
- 21 May 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the specificity and sensitivity of the diagnostic criteria for fibromyalgia after conducting local validation in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (1 listed)
- At least 18 years of age; Patients with chronic widespread pain; Able to complete the questionnaire.
Key exclusion criteria (1 listed)
- Terminal patients with severe psychiatric diseases, tumors, systemic lupus erythematosus, systemic sclerosis, or other serious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond thatThe FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that | Diagnostic test | Fibromyalgia, chronic widespread pain |
Primary outcome
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.
6 secondary outcomes
QOL as measured by Short Form-36 Health Status Questionnaire(SF-36)
Time frame: up to 1 week
Fibromyalgia symptoms severity as measured by the Rebised Fibromyalgia Impact Questionnaire(FIQR)
Time frame: up to 1 week
Depression scores as measured by Beck depression inventory(BDI)
Time frame: up to 1 week
Stress scores as measured by Perceived Stress Scale(PSS)
Time frame: up to 1 week
Sleep scores as measured by Pittsburgh sleep quality index(PSQI)
Time frame: up to 1 week
Fatigue was measured by the Multidimensional Fatigue Inventory(MFI-20)
Time frame: up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of fibromyalgia with the Polysymptomatic Distress Scale(PDS) (time frame: up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.