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Evaluation of Smell and Taste in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03823937
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.

Condition or disease Intervention/treatment
Fibromyalgia Other: Sniffin' Sticks test and Taste strips

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Smell and Taste in Patients With Fibromyalgia
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : July 2, 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Fibromyalgia
Diagnosed with ACR 2016 criteria
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.


Control
18-70 years healthy subjects
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.





Primary Outcome Measures :
  1. number of participants with normal olfactory function [ Time Frame: Baseline ]
    total smell test score

  2. number of participants with normal gustatory function [ Time Frame: Baseline ]
    total taste score


Secondary Outcome Measures :
  1. number of participants with low quality of life [ Time Frame: Baseline ]
    A EQ-5D-3L is a standardized instrument for measuring generic health status.

  2. number of participants with anxiety [ 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. number of participants with alexithymia [ Time Frame: Baseline ]
    Toronto alexithymia scale

  4. number of participants with depression [ 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.

    10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823937


Locations
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Turkey
Sultan Abdulhamid Han Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Tugba Ozsoy-Unubol    +902165422020 ext 3857    tugbaozsoyy@gmail.com   
Sponsors and Collaborators
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications:
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Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier: NCT03823937     History of Changes
Other Study ID Numbers: Tugba Ozsoy2
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey:
fibromyalgia
smell
taste

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases