Evaluation of Smell and Taste in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Evaluation of Smell and Taste in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823937
• Other study ID #: Tugba Ozsoy2
• Status: Completed
• Start date: January 2, 2019
• Est. completion date: June 10, 2019

Study information

• Verified date: May 2020
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 10, 2019
• Est. primary completion date: June 2, 2019
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years of fibromyalgia patients

• Giving informed consent

• Knowing how to write and read in Turkish

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Sniffin' Sticks test and Taste strips
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.

Locations

Country	Name	City	State
Turkey	Sultan Abdulhamid Han Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Lötsch 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sniffin' Sticks Test Score	total smell test score minimum score: 0 maximum score: 48 Higher scores reflect better smell function.	Baseline
Primary	Taste Strips Test Score	total taste score minimum score: 0 maximum score: 16 Higher scores indicate better taste function.	Baseline
Secondary	Quality of Life Score	A EQ-5D-3L is a standardized instrument for measuring generic health status. minimum score: -0.59 maximum score: 1 Higher scores indicate better health status.	Baseline
Secondary	Anxiety Score	Hamilton anxiety scale: Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	Baseline
Secondary	Alexithymia Score	Toronto alexithymia scale minimum score: 20 maximum score: 100 Cut-off scores: =50=no alexithymia, 51-60=borderline alexithymia, and =61=alexithymia	Baseline
Secondary	Depression Score	Hamilton depression scale is designed to rate the severity of depression in patients. Although it contains 21 areas, calculate the patient's score on the first 17 answers.; Minimum score:0 Maximum score: 53 Higher scores reflect more severe depression.	Baseline