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临床试验/NCT04260906
NCT04260906已完成不适用

The Impact Of Auricular Vagus Nerve Stimulation On Pain And Life Quality In Patients With Fibromyalgia Syndrome

Bahçeşehir University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Short Form-36 Score

研究概览

简要总结

The purpose of this study is to evaluate the impact of auricular vagus nerve stimulation, applied in conjunction with an exercise treatment program, on pain and life quality in patients with Fibromyalgia Syndrome (FMS). To achieve the study objectives, 60 female patients between the ages 18 - 50, with diagnosed FMS according to American College of Rheumatology (ACR) 2010 diagnostic criteria, were randomly divided into 2 groups of 30. The first group was assigned 20 sessions of a home-based exercise program, while the second group was assigned 20 sessions of auricular vagus nerve stimulation and 20 sessions of a home-based exercise program. Patients were assessed before and after the treatments using the Visual Analog Scale (VAS) for pain, Beck Depression Scale for depression, Beck Anxiety Scale for anxiety, Fibromyalgia Impact Questionnaire (FIQ) for functional evaluation and Short Form-36 (SF-36) for life quality.

In this randomized controlled trial, comparisons within the groups revealed that both groups had statistically significant improvements in pain, depression, anxiety, functionality and life quality scores (p<0.05), whilst comparisons across the groups revealed that the group experiencing the vagus nerve stimulation had no statistically significant differences between the baseline scores, except for those of SF-36's sub-parameters of physical function, social functionality and pain. In fact comparisons across the groups after the interventions revealed that the group experiencing the vagus nerve stimulation had better scores but not statistically significant. From analysis of this data, the investigators observed that vagus nerve stimulation in FMS treatment did not give additional benefit together with exercise, except for three sub-parameters of SF-36. It was identified that further studies which separately investigate the effects of vagus nerve stimulation and exercise on FMS with longer follow-up periods and an increased number of patients are needed.

详细描述

Fibromyalgia syndrome (FMS) is a syndrome, characterized by chronic widespread pain that continues for a minimum of 3 months and pain felt upon 11 out of 9 pairs of identified sore points. It is often accompanied by systemic symptoms such as fatigue, sleep disorders, cognitive dysfunction and depression . Moreover, headache, dysmenorrhea, irritable bowel syndrome, restless leg syndrome, chest pain, jaw pain, stomach ache, sensitive skin, mitral valve prolapses, Sicca symptoms, Raynaud phenomenon and female urethral syndrome accompany the clinical picture in many patients with FMS . This syndrome, the etiology of which is unknown, is commonly seen in women and the age of onset is usually 30 - 50 . Its prevalence among the general population is reported to be between 2.9 - 4.7 percent . While it is often seen in the adult population, it can also be observed in childhood or later age . Recent research studies show that various anomalies in genetic structure, autonomic nervous system (ANS), neurotransmitters, hypothalamic-hypophyseal-adrenal axe hormones, oxidative stress, pain modulation centers, central sensitization and muscular structure occur in FMS . The etiology of FMS is still not fully understood; nonetheless, the data reveals that this syndrome may stem from dysfunctionality in ANS . Sympathetic nervous system (SNS) dominance is widespread in FMS, chronic fatigue, irritable bowel syndrome and interstitial cystitis . A highly peripheral sympathetic tone causes regional ischemia, which in turn causes widespread pain. Therapeutic interventions that result in vasodilatation (e.g. exercise) and appropriate autonomic changes are proven to be effective for reducing pain levels .

The "great and perfect protector" of the body, the vagus nerve includes a neuro-endocrine-immune network that ensures homeostasis. The vagus nerve, which has reciprocal neural connections with more than one region of the brain, serves a control center that combines sensitive information and provides appropriate feedback responses. Recent studies show that the vagus nerve also encompasses inflammation, mood and pain regulation. All of these can be modulated with vagus nerve stimulation. Vagus nerve stimulation can generate a neuromodulating effect to activate other natural protective paths to improve health . The development of vagus nerve stimulation began in the 19th century. A number of new electrical stimulation devices have now been developed. Non-invasive transcutaneal devices stimulate the vagus nerve through the auricular branch or from the carotid. Moreover, they are used in the treatment of various disorders, such as epilepsy, pain and headache . Recent pre-clinical studies have shown that vagus nerve stimulation heavily modulates pain in humans and is quite effective. The use of a medical device allows the auricular branch of the vagus nerve to be stimulated without surgical intervention. Consequently, it has been found that the threshold of pain is elevated and mechanical pain sensitivity is reduced .

As a result of these completed studies, there is a possibility that FMS is a disease, which occurs through ANS impairment. Vagus nerve stimulation could be used as an additional treatment method to improve the ANS impairment. However, as there are no studies that investigate vagus nerve stimulation in FMS, this study is designed and executed.

MATERIAL AND METHOD

Our study, in which the researchers investigated the impact of auricular vagus nerve stimulation on pain and life quality in patients with FMS, was conducted in Beykoz Public Hospital's Department of Physiotherapy and Rehabilitation. A total of 60 female patients within the age range 18 - 50, with diagnosed FMS by a physiatrist according to 2010 ACR criteria, were included in this study. Only females were included to make groups homogenous and ended the age range at 50 to avoid comorbid illnesses seen in elderly people and also menopause. Pregnants, perimenopausal and postmenaopausal women are not included, also those experiencing any comorbid illnesses like neurological deficits, diabetes, neuropathic disorders, chronic inflammation, immune deficiency, cardiac disorders and current vitamin D intake were excluded from the study. In addition those who started using new drugs in the last month and during the study were not included. Patients who experienced vasovagal syncope in their past could not participate in the study.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Females 18- 50 of age

排除标准

  • Pregnancy
  • Menopause,
  • Neurological deficits
  • Neuropathic disorders
  • Chronic inflammation
  • Immune deficiency
  • Cardiac disorders
  • Current drug usage
  • Vasovagal syncope

结局指标

主要结局

Short Form-36 Score

时间窗: 4 weeks

Life quality of patients was evaluated using the SF-36 life quality scale. The Turkish validity and reliability of this scale was carried out by Koçyiğit et al. Investigating life quality regarding overall health, this questionnaire contains 36 questions in 8 different categories. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.

次要结局

未报告次要终点

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

hasan kerem alptekin

director of health sciences institute

Bahçeşehir University

研究点 (2)

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