Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and sensitivity to touch. Current treatments often provide only partial relief. This study evaluates a non-invasive technique called transcutaneous auricular vagus nerve stimulation (TaVNS), which delivers gentle electrical impulses to a part of the ear connected to the vagus nerve. The vagus nerve plays an important role in regulating pain, stress, and autonomic body functions such as sleep.
In this randomized controlled pilot trial, participants with fibromyalgia are assigned to receive either active TaVNS or sham (placebo) stimulation for 30 minutes per day, five days per week, over a four-week period. Participants are followed for a total of 8 weeks. The investigators will assess outcomes including pain intensity, sleep quality, central sensitization, and fear of movement (kinesiophobia).
详细描述
Fibromyalgia (FM) is a chronic pain syndrome associated with widespread musculoskeletal pain, fatigue, sleep disturbances, and autonomic dysregulation. Current treatments provide only partial relief, highlighting the need for novel therapeutic approaches.
Rationale:
The vagus nerve is a key regulator of autonomic and inflammatory processes. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive technique that can modulate vagal activity through electrodes placed on the external ear, offering a potential alternative to surgically implanted vagus nerve stimulators.
Study Design:
This is a randomized, sham-controlled pilot trial conducted at Istanbul Medipol University. Thirty participants with fibromyalgia are randomized in a 1:1 ratio to receive either active TaVNS or sham stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants and outcome assessors were blinded to group allocation. The treating clinician who applied stimulation was aware of assignment but did not participate in outcome assessment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Diagnosis of fibromyalgia according to the 2016 revised ACR criteria
- •Receiving stable pharmacological and/or non-pharmacological treatment for at least 3 months
- •Ability to understand study procedures and provide informed consent
排除标准
- •History of epilepsy or cardiac arrhythmia
- •Acute or chronic infection
- •Heart failure (NYHA class II-IV)
- •Renal failure stage II or higher
- •Active malignancy
- •Psychotic disorders or current psychiatric treatment
- •Diagnosis of immune-mediated rheumatic disease
研究组 & 干预措施
Active TaVNS
Participants received active transcutaneous auricular vagus nerve stimulation (TaVNS) using the VagusStim® device (Vagus Medical Technologies, Istanbul, Türkiye). The electrode was placed on the left cymba concha and stimulation was applied for 30 minutes per day, 5 days per week, over 4 weeks (20 sessions). Stimulation parameters included 1-30 Hz frequency, 50-250 μs pulse width, and current individually adjusted (0.1-36 mA) to each participant's sensory threshold.
干预措施: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) (Device)
Sham TaVNS
Participants underwent sham stimulation using the same VagusStim® device under identical conditions. The electrode was placed on the left earlobe, an area without vagal innervation, and sessions lasted 30 minutes per day, 5 days per week, for 4 weeks. No effective vagus nerve stimulation was delivered, maintaining participant blinding.
干预措施: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Device)
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: Baseline, Week 2, Week 4, Week 8
The FIQ evaluates the overall health status and functional impact of fibromyalgia, including physical functioning, pain, fatigue, and mood. Scores range from 0 to 100, with higher scores reflecting greater disease impact.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline, Week 2, Week 4, Week 8
The PSQI is a validated self-report questionnaire that assesses subjective sleep quality and disturbances over the past month. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Central Sensitization Inventory (CSI)
时间窗: Baseline, Week 2, Week 4, Week 8
The CSI is a 25-item self-report questionnaire assessing symptoms related to central sensitization, including sensitivity to pain, fatigue, and cognitive complaints. Scores range from 0 to 100, with higher scores indicating greater sensitization.
次要结局
- Tampa Scale for Kinesiophobia (TSK)(Baseline, Week 2, Week 4, Week 8)
- Visual Analog Scale (VAS) for Pain(Baseline, Week 2, Week 4, Week 8)
研究者
Hatice Betigul Meral
Principal Investigator
Medipol University