Fibromyalgia
Conditions
Keywords
fibromyalgia, smell, taste
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.
Interventions
OTHERSniffin' 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.
Sponsors
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sniffin' Sticks Test Score | Baseline | total smell test score minimum score: 0 maximum score: 48 Higher scores reflect better smell function. |
| Taste Strips Test Score | Baseline | total taste score minimum score: 0 maximum score: 16 Higher scores indicate better taste function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Score | 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. |
| Anxiety Score | 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. |
| Alexithymia Score | Baseline | Toronto alexithymia scale minimum score: 20 maximum score: 100 Cut-off scores: ≤50=no alexithymia, 51-60=borderline alexithymia, and ≥61=alexithymia |
| Depression Score | 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. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fibromyalgia Diagnosed with ACR 2016 criteria
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. | 30 |
| Control 18-70 years healthy subjects
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. | 20 |
| Total | 50 |
Baseline characteristics
| Characteristic | Fibromyalgia | Control | Total |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 8.47 | 45.65 years STANDARD_DEVIATION 9.95 | 45.86 years STANDARD_DEVIATION 8.99 |
| BMI | 28.07 kg/m^2 STANDARD_DEVIATION 5.37 | 26.04 kg/m^2 STANDARD_DEVIATION 4.24 | 27.26 kg/m^2 STANDARD_DEVIATION 5.01 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 18 Participants | 45 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Sniffin' Sticks Test Score
total smell test score minimum score: 0 maximum score: 48 Higher scores reflect better smell function.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Sniffin' Sticks Test Score | 25.96 score on a scale | Standard Deviation 6.5 |
| Control | Sniffin' Sticks Test Score | 36.40 score on a scale | Standard Deviation 4.5 |
Primary
Taste Strips Test Score
total taste score minimum score: 0 maximum score: 16 Higher scores indicate better taste function.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Taste Strips Test Score | 9.93 score on a scale | Standard Deviation 2.65 |
| Control | Taste Strips Test Score | 13.55 score on a scale | Standard Deviation 1.76 |
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Alexithymia Score | 57.20 score on a scale | Standard Deviation 13.12 |
| Control | Alexithymia Score | 46.80 score on a scale | Standard Deviation 11.3 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Anxiety Score | 21.23 score on a scale | Standard Deviation 9.22 |
| Control | Anxiety Score | 5.45 score on a scale | Standard Deviation 4.24 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Depression Score | 18.03 score on a scale | Standard Deviation 7.75 |
| Control | Depression Score | 5.70 score on a scale | Standard Deviation 5.98 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia | Quality of Life Score | 0.452 score on a scale | Standard Deviation 0.288 |
| Control | Quality of Life Score | 0.916 score on a scale | Standard Deviation 0.109 |