NCT02449395

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

11 months

First QC Date

May 2, 2015

Last Update Submit

November 19, 2018

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ)

    up to 1 week

Secondary Outcomes (6)

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

    up to 1 week

  • Pain scores as measured by Numerical rating scale (NRS)

    up to 1 week

  • Fatigue scores as measured by Multidimensional Assessment Fatigue (MAF)

    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

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Age 18 years or older.
  • Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for Fibromyalgia.

You may not qualify if:

  • Don't fulfill any classification criterions for Fibromyalgia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

  • 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.

    PMID: 39827119DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Juan Jiao, M.D.,PhD

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician

Study Record Dates

First Submitted

May 2, 2015

First Posted

May 20, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations

CN(1)