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Completed

NCT Number: NCT03823937

Evaluation of Smell and Taste in Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Anosmia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Olfaction Disorders Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sensation Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sniffin' Sticks test and Taste strips

Other

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.

Primary outcomes

  1. Sniffin' Sticks Test Score

    Time frame: Baseline

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

  2. Taste Strips Test Score

    Time frame: Baseline

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

Secondary outcomes

  1. Quality of Life Score

    Time frame: Baseline

    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.

  2. Anxiety Score

    Time frame: Baseline

    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.

  3. Alexithymia Score

    Time frame: Baseline

    Toronto alexithymia scale minimum score: 20 maximum score: 100 Cut-off scores: ≤50=no alexithymia, 51-60=borderline alexithymia, and ≥61=alexithymia

  4. Depression Score

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Evaluation of Smell and Taste in Patients With Fibromyalgia

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2019
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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