Comparison of the Effects of Different Physiotherapy Methods in Women With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Pain intensity as measured by the Visual Analog Scale (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with fibromyalgia
- •Being female between the ages of 18-65
- •Volunteering to participate in the study
排除标准
- •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
研究组 & 干预措施
CTM Group
Connective tissue massage (CTM) will be applied to this group 2 days a week for 6 weeks
干预措施: Connective tissue massage (Other)
taVNS Group
Transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks
干预措施: Transcutaneous auricular vagus nerve stimulation (Other)
CTM+taVNS Group
Connective tissue massage (CTM) and transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks.
干预措施: Connective tissue massage (Other)
CTM+taVNS Group
Connective tissue massage (CTM) and transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group 2 days a week for 6 weeks.
干预措施: Transcutaneous auricular vagus nerve stimulation (Other)
结局指标
主要结局
Pain intensity as measured by the Visual Analog Scale (VAS)
时间窗: 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).
时间窗: 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.
次要结局
- Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, 6th week (after treatment))
- Fatigue as measured by the Visual Analog Scale (VAS).(Baseline, 6th week (after treatment))
- Depression as measured by the Beck Depression Inventory (BDI)(Baseline, 6th week (after treatment))
- Anxiety as measured by the Beck Anxiety Inventory (BAI)(Baseline, 6th week (after treatment))
- Autonomic symptoms as measured by the Composite Autonomic Symptom Score 31 (COMPASS 31)(Baseline, 6th week (after treatment))
- Quality of life as measured by the Nottingham Health Profile (NHP)(Baseline, 6th week (after treatment))
- Compliance with the information and recommendations as measured by the Visual Analog Scale (VAS)(6th week (after treatment))
研究者
Beyza Avcı
Specialist Physiotherapist and PhD Candidate
Ankara Yildirim Beyazıt University