Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia | Diagnosed with ACR 2016 criteria |
| |
| Control | 18-70 years healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Anxiety Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
18-70 years old fibromyalgia diagnosed with 2016 ACR criteria and age, sex-matched healthy controls will be included in the study.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sultan Abdulhamid Han Training and Research Hospital | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29721540 | Background | 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. | |
| 22985737 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sniffin' Sticks Test Score | total smell test score minimum score: 0 maximum score: 48 Higher scores reflect better smell function. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Adverse Events were not monitored/assessed
Adverse Events were not monitored/assessed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tugbaozsoy | Sultan.abdulhamid | +905074583382 | tugbaozsoyy@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2019 | May 30, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| 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 |
| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
|
|
| Primary | Taste Strips Test Score | total taste score minimum score: 0 maximum score: 16 Higher scores indicate better taste function. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D009422 |
| Nervous System Diseases |
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |