Fibromyalgia
Conditions
Brief summary
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.
Interventions
Connective tissue massage (CTM) is a manual technique that involves applying specific dragging or pulling movements to the superficial and subcutaneous connective tissue layers
OTHERTranscutaneous auricular vagus nerve stimulation
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
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Having been diagnosed with fibromyalgia * Being female between the ages of 18-65 * Volunteering to participate in the study
Exclusion criteria
* Diagnosed neurological and infectious diseases * Uncontrolled endocrine and/or autoimmune diseases * Serious psychiatric disorders (bipolar disorder, schizophrenia, psychosis, etc.) * Pregnancy or breastfeeding * Malignancy * History of known arrhythmia or any implanted electronic device * Presence of sensory loss * Acute inflammation, open wounds, erythema in massage areas * History of any surgery within the last 6 months * Having received physical therapy for FM within the last 6 months and/or being included in a new treatment program during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity as measured by the Visual Analog Scale (VAS) | Baseline, 6th week (after treatment) | 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. |
| Health status and disease severity as measured by the Fibromyalgia Impact Questionnaire (FIQ). | Baseline, 6th week (after treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) | Baseline, 6th week (after treatment) | 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. |
| Fatigue as measured by the Visual Analog Scale (VAS). | Baseline, 6th week (after treatment) | '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. |
| Depression as measured by the Beck Depression Inventory (BDI) | Baseline, 6th week (after treatment) | 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. |
| Anxiety as measured by the Beck Anxiety Inventory (BAI) | Baseline, 6th week (after treatment) | 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. |
| Autonomic symptoms as measured by the Composite Autonomic Symptom Score 31 (COMPASS 31) | Baseline, 6th week (after treatment) | 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 |
| Quality of life as measured by the Nottingham Health Profile (NHP) | Baseline, 6th week (after treatment) | 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. |
| Compliance with the information and recommendations as measured by the Visual Analog Scale (VAS) | 6th week (after treatment) | '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. |
Outcome results
None listed