NCT03757702

Brief Summary

This study aims to investigate trunk position sense, postural stability and spine posture in fibromyalgia patients and healthy women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 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

July 10, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 23, 2019

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 26, 2018

Last Update Submit

January 19, 2019

Conditions

FibromyalgiaPostural LordosisPostural KyphosisProprioceptionPostural StabilityBalance

Outcome Measures

Primary Outcomes (1)

  • Joint Position Sense

    Trunk position sense will be evaluated with a digital inclinometer.

    20 days

Secondary Outcomes (2)

  • Postural Stability

    20 days

  • Spinal Posture

    20 days

Study Arms (2)

Fibromiyalgia group

women with FMS between 18-65 years of age and being volunteered.

Other: Evaluation

Healthy group

healthy women and being volunteereed

Other: Evaluation

Interventions

EvaluationOTHER

Trunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.

Fibromiyalgia groupHealthy group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy women and Fibromyalgia patient

You may qualify if:

  • being women
  • having FMS
  • being volunteer

You may not qualify if:

  • have neurologic, infectious, endocrine, and other severe psychological disorders
  • malignancy,
  • being pregnant
  • any condition interfering with evaluation (advanced cardiac respiratory or orthopedic problems)
  • spinal deformities such as scoliosis, spine surgery
  • inflammatory rheumatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Özge Çoban

    Research Assitant

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 29, 2018

Study Start

July 10, 2018

Primary Completion

November 30, 2018

Study Completion

January 1, 2019

Last Updated

January 23, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)