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| ID | Type | Description | Link |
|---|---|---|---|
| 2865 | Other Identifier | Ankara Yıldırım Beyazıt University Scientific Research Projects Coordination Unit |
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The aim of our study was to examine and compare the effects of different physiotherapy methods, namely connective tissue massage, transcutaneous auricular vagus nerve stimulation and both, on pain, health status, sleep quality, fatigue, psychosocial status, autonomic symptoms and quality of life in women with fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTM Group | Experimental | Connective tissue massage (CTM) will be applied to this group 2 days a week for 6 weeks |
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| taVNS Group | Experimental | Transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks |
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| CTM+taVNS Group | Experimental | Connective tissue massage (CTM) and transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connective tissue massage | Other | Connective tissue massage (CTM) is a manual technique that involves applying specific dragging or pulling movements to the superficial and subcutaneous connective tissue layers |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity as measured by the Visual Analog Scale (VAS) | In the VAS scale, which is a 10 cm scale, '0' represents no pain and '10' represents the worst imaginable pain. The distance from the marked point to the 0 point is measured using a ruler, and the pain intensity is recorded in centimeters. | Baseline, 6th week (after treatment) |
| Health status and disease severity as measured by the Fibromyalgia Impact Questionnaire (FIQ). | This questionnaire assesses the severity of symptoms, overall impact, and physical function. The total score for the questionnaire ranges from 0 to 100, with higher scores indicating a greater impact of the illness on patients. | Baseline, 6th week (after treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. Each question is scored on a scale of 0-3, with a total score ranging from 0 to 21. | Baseline, 6th week (after treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital | Recruiting | Ankara | 06560 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Transcutaneous auricular vagus nerve stimulation | Other | Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique. It targets vagus nerve stimulation through the transcutaneous application of electrical impulses to the auricle |
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| Fatigue as measured by the Visual Analog Scale (VAS). |
'0' means no fatigue and '10' means unbearable fatigue. Fatigue level is recorded by measuring the distance from the marked point on the VAS (a 10 cm scale) to the 0 point using a ruler. |
| Baseline, 6th week (after treatment) |
| Depression as measured by the Beck Depression Inventory (BDI) | The BDI measures individuals' levels of depression. The scale consists of 21 items in total. Scores range from 0 to 63, with higher scores indicating higher levels of depression. | Baseline, 6th week (after treatment) |
| Anxiety as measured by the Beck Anxiety Inventory (BAI) | The BAI measures individuals' anxiety levels. The scale consists of 21 items in total. Scores range from 0 to 63, with higher scores indicating higher anxiety levels. | Baseline, 6th week (after treatment) |
| Autonomic symptoms as measured by the Composite Autonomic Symptom Score 31 (COMPASS 31) | The COMPASS-31 (Composite Autonomic Symptom Score-31) scale measures neurodegenerative system symptoms through 31 patient-reported questions. A higher score indicates worse autonomic dysfunction | Baseline, 6th week (after treatment) |
| Quality of life as measured by the Nottingham Health Profile (NHP) | The NHP is a general quality of life scale that measures a person's perceived health problems and the extent to which these problems affect normal daily activities. 0 indicates the best health status, and 100 indicates the worst health status. | Baseline, 6th week (after treatment) |
| Compliance with the information and recommendations as measured by the Visual Analog Scale (VAS) | '0' means I did not follow any of the information and suggestions, and '10' means I followed them completely. The distance from the marked point on the VAS (a 10 cm scale) to the 0 point is measured using a ruler, and the compliance value is recorded. | 6th week (after treatment) |
| D009422 |
| Nervous System Diseases |