NCT03823937

Brief Summary

Patients diagnosed with fibromyalgia syndrome according to 2016 ACR criteria and 18-70 years old healthy subjects will be included in the study. Their smell and taste will be assessed with sniffin sticks and taste strips. Besides they will be evaluated for quality of life, anxiety, depression, and alexithymia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

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

January 2, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

January 27, 2019

Results QC Date

September 19, 2019

Last Update Submit

May 30, 2020

Conditions

Fibromyalgia

Keywords

fibromyalgiasmelltaste

Outcome Measures

Primary Outcomes (2)

  • Sniffin' Sticks Test Score

    total smell test score minimum score: 0 maximum score: 48 Higher scores reflect better smell function.

    Baseline

  • Taste Strips Test Score

    total taste score minimum score: 0 maximum score: 16 Higher scores indicate better taste function.

    Baseline

Secondary Outcomes (4)

  • Quality of Life Score

    Baseline

  • Anxiety Score

    Baseline

  • Alexithymia Score

    Baseline

  • Depression Score

    Baseline

Study Arms (2)

Fibromyalgia

Diagnosed with ACR 2016 criteria

Other: Sniffin' Sticks test and Taste strips

Control

18-70 years healthy subjects

Other: Sniffin' Sticks test and Taste strips

Interventions

Sniffin' Sticks test and Taste stripsOTHER

Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen. The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth.

ControlFibromyalgia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18-70 years old fibromyalgia diagnosed with 2016 ACR criteria and age, sex-matched healthy controls will be included in the study.

You may qualify if:

  • years of fibromyalgia patients
  • Giving informed consent
  • Knowing how to write and read in Turkish

You may not qualify if:

  • Mentally retarded patients
  • Psychiatric disorders (bipolar disorder, schizophrenia etc.)
  • Severe organ failure (kidney, liver, heart failure)
  • History of head trauma
  • Any disorder associated with smell and taste functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Hur K, Choi JS, Zheng M, Shen J, Wrobel B. Association of alterations in smell and taste with depression in older adults. Laryngoscope Investig Otolaryngol. 2018 Feb 21;3(2):94-99. doi: 10.1002/lio2.142. eCollection 2018 Apr.

    PMID: 29721540BACKGROUND

  • Lotsch J, Kraetsch HG, Wendler J, Hummel T. Self-ratings of higher olfactory acuity contrast with reduced olfactory test results of fibromyalgia patients. Int J Psychophysiol. 2012 Nov;86(2):182-6. doi: 10.1016/j.ijpsycho.2012.09.003. Epub 2012 Sep 15.

    PMID: 22985737BACKGROUND

MeSH Terms

Conditions

FibromyalgiaAnosmia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesOlfaction DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Tugbaozsoy
Organization
Sultan.abdulhamid
tugbaozsoyy@gmail.com
+905074583382

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

January 27, 2019

First Posted

January 31, 2019

Study Start

January 2, 2019

Primary Completion

June 2, 2019

Study Completion

June 10, 2019

Last Updated

June 11, 2020

Results First Posted

June 11, 2020

Record last verified: 2020-05

Locations

TU(1)