FibromyalgiaNCT02449395
Cross-sectional Study of Fibromyalgia
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 is designed to collect data on precipitating factors, diagnosis, morbidity, therapy, quality of life, and symptom severity, etc. informations in patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Mar 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients fulfilling 1990 ACR criterion for fibromyalgia be seen in the Fibromyalgia Outpatient Service which belonged to the Department of Rheumatism, Guang'anmen Hospital, Beijing China.
Who may be able to join
- Age 18 years or older.
- Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for Fibromyalgia.
Who cannot join
- Don't fulfill any classification criterions for Fibromyalgia.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
About this study
Official title: A Cross-sectional Study of Fibromyalgia in Beijing
This study is designed to collect data on precipitating factors, diagnosis, morbidity, therapy, quality of life, and symptom severity, etc. informations in patients with fibromyalgia.
Read the detailed description
Patients fulfilling 1990 ACR criterion for fibromyalgia will be recruited in Fibromyalgia outpatient service which is belonged to the Department of Rheumatism. Except collecting patients' demographic and social characteristic informations, rheumatologist also carry out a comprehensive evaluation including patient current history, current medication use, and tender point examination for a diagnosis or confirmation of fibromyalgia and treatment recommendations. Patients with fibromyalgia will be asked to fill a set of questionnaires to evaluate their quality of life, symptoms severity, quality of sleep and emotion. The study will be conducted in Beijing, China.
- Conditions
- Fibromyalgia
- Medical subject headings
- Fibromyalgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ)
Measured: up to 1 week
Secondary outcomes (6)
QOL as measured by Short Form-36 Health Status Questionnaire (SF-36)
Measured: up to 1 week
Pain scores as measured by Numerical rating scale (NRS)
Measured: up to 1 week
Fatigue scores as measured by Multidimensional Assessment Fatigue (MAF)
Measured: up to 1 week
Depression scores as measured by Beck depression inventory (BDI)
Measured: up to 1 week
Stress scores as measured by Perceived Stress Scale (PSS)
Measured: up to 1 week
Sleep scores as measured by Pittsburgh sleep quality index (PSQI)
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 posted20 May 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Juan Jiao, M.D.,PhD, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449395
- Sponsor's protocol ID
- 39301
- Status last verified
- Nov 2018
- First submitted
- 2 May 2015
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Y, Liu P, Li Z, Wu S, Long M, Li Y, Jiao J, Xie Z. Quality of life, pain, depression, fatigue and sleep in patients with remission or mild fibromyalgia: a comparison with remission or low disease activity rheumatoid arthritis and healthy controls. BMC Musculoskelet Disord. 2025 Jan 18;26(1):67. doi: 10.1186/s12891-025-08323-6.
PubMed 39827119
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Fibromyalgia in Beijing
- ClinicalTrials.gov ID
- NCT02449395
- Acronym / sponsor ID
- 39301
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 20 May 2015 (estimated)
- 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 is designed to collect data on precipitating factors, diagnosis, morbidity, therapy, quality of life, and symptom severity, etc. informations in patients with fibromyalgia.
Detailed description
Patients fulfilling 1990 ACR criterion for fibromyalgia will be recruited in Fibromyalgia outpatient service which is belonged to the Department of Rheumatism. Except collecting patients' demographic and social characteristic informations, rheumatologist also carry out a comprehensive evaluation including patient current history, current medication use, and tender point examination for a diagnosis or confirmation of fibromyalgia and treatment recommendations. Patients with fibromyalgia will be asked to fill a set of questionnaires to evaluate their quality of life, symptoms severity, quality of sleep and emotion. The study will be conducted in Beijing, China.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients fulfilling 1990 ACR criterion for fibromyalgia be seen in the Fibromyalgia Outpatient Service which belonged to the Department of Rheumatism, Guang'anmen Hospital, Beijing China.
Key inclusion criteria (2 listed)
- Age 18 years or older.
- Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for Fibromyalgia.
Key exclusion criteria (1 listed)
- Don't fulfill any classification criterions for Fibromyalgia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ)
Time frame: up to 1 week
6 secondary outcomes
QOL as measured by Short Form-36 Health Status Questionnaire (SF-36)
Time frame: up to 1 week
Pain scores as measured by Numerical rating scale (NRS)
Time frame: up to 1 week
Fatigue scores as measured by Multidimensional Assessment Fatigue (MAF)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 39827119Wang Y, Liu P, Li Z, Wu S, Long M, Li Y, Jiao J, Xie Z. Quality of life, pain, depression, fatigue and sleep in patients with remission or mild fibromyalgia: a comparison with remission or low disease activity rheumatoid arthritis and healthy controls. BMC Musculoskelet Disord. 2025 Jan 18;26(1):67. doi: 10.1186/s12891-025-08323-6.
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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.
Juan Jiao, M.D.,PhD principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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 2 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: finished, as of the sponsor's last update on 20 Nov 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ) (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?
On the ClinicalTrials.gov record for NCT02449395, which also lists 1 linked publication.
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 20 Nov 2018.