Work-Related Fibromyalgia | NCT03535454

Studies
Work-Related Fibromyalgia

NCT03535454

Sponsor

Gaziosmanpasa Research and Education Hospital

Status

Completed

Last Update Posted

Oct 12, 2018Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Fibromyalgia, Secondary

Interventions

working hours

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Sep 1, 2018Actual

Completion Date

Oct 11, 2018Actual

First Submitted Date

May 14, 2018

First Submission Date that Met QC Criteria

May 14, 2018

First Posted Date

May 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2018

Last Update Posted Date

Oct 12, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehmet Akif GÜLER, Principal Investigator, Gaziosmanpasa Research and Education HospitalPrincipal Investigator

Lead Sponsor

Gaziosmanpasa Research and Education HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The research is about fibromyalgia prevalency in working population and searching work-related fibromyalgia.

Detailed Description

4 different job population will be included in the study. Totally 200 people wil be included and evaluated. All participants will be women. The investigators will diagnose fibromyalgia with 2016 updated diagnostic criteria and evaluate work related musculoskeletal pain with nordic musculoskeletal questionnaire.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Factory workers			Other: working hours
Nurses			Other: working hours
Janitors			Other: working hours
Data automation employees			Other: working hours

Interventions

Name	Type	Description	Arm Group Labels	Other Names
working hours	Other	weekly working hours	Data automation employees Factory workers Janitors Nurses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
work related fibromyalgia	fibromyalgia in working population	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

working at least 3 months in same working place

Exclusion Criteria:

Diagnosed with the other musculoskeletal diseases

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Working woman

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa Taksim Research and Education Hospital		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia
D009140	Musculoskeletal Diseases

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided