Comparative Study Between the Outcome of Noninvasive Vagus Nerve Stimulation and Medical Treatment in Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Fibromyalgia severity scale
研究概览
简要总结
Vagus nerve stimulation is thought to reduce sympathetic nerve outflow and so can improve sympathetic hyperactivity in fibromyalgia patients. We aimed in the current study, to evaluate the effect of the cervical transcutaneous vagus nerve stimulation in comparison to conventional medical treatment in Egyptian fibromyalgia patients.
详细描述
In the current study, the investigators will investigate the effects of transcutaneous cervical vagus stimulation (t-VNS) on 90 Female patients above 18 years, with a clinical diagnosis of fibromyalgia according to 2016 American College of Rheumatology (ACR) fibromyalgia diagnostic criteria.
The ninety patients will be divided into 3 groups:
Group A: will receive cervical transcutaneous vagus nerve stimulation that will be carried out with a transcutaneous electrical nerve stimulation (TENS) device, using a small self-adhesive surface electrodes (1 cm diameter). The electrodes will be positioned on the surface of the neck that corresponds to the position of the left cervical branch of the vagus nerve, using a biphasic, asymmetrical waveform with a pulse duration that is less than 250 microseconds and a frequency of 20 hertz. Intensity is adjusted according to the sensory threshold level of each patient, each session lasts for 30 minutes. All patients will receive 3 sessions per week for a total of 12 sessions, The sessions will be carried on at Department of Rheumatology and Rehabilitation, Cairo University Hospital.
Group B will receive cervical t-VNS in the same protocol like group A, in addition to medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.
Group C will receive medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients above 18 years, with a clinical diagnosis of fibromyalgia according to 2016 ACR fibromyalgia diagnostic criteria, will be included in this study.
排除标准
- •- Pregnant, and postmenopausal women.
- •Patients with any medical disorder including: cardiovascular, pulmonary, renal, hepatic, endocrine, blood, gastrointestinal, diabetes, neuropathic disorders, psychiatric disorders (for example; post traumatic stress disorder (PTSD), mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders) and/or neurodegenerative disorders (e.g., Parkinson's, Alzheimer's, Huntington's disease).
- •Cancer diagnosis within the preceding 5 years.
- •Planned surgery.
- •Use of other medical devices electrically active for example a cardiac pacemaker, or TENS for chronic pain.
- •Electrocardiogram (ECG) abnormalities.
- •History of Electroconvulsive therapy (ECT).
- •Symptomatic orthostatic hypotension, or history of recurrent vagal syncope.
- •History of vagotomy.
- •Uncontrolled hypertension or hypotension.
- •Documented sleep apnea.
- •Other rheumatic diseases like (Rheumatoid Arthritis, Systemic lupus erythematosus, Seronegative spondyloarthropathies).
研究组 & 干预措施
1 Vagus nerve stimulation
The first group will receive cervical transcutaneous vagus nerve stimulation that will be carried out with a TENS device, using a small self-adhesive surface electrodes (1 cm diameter). The electrodes will be positioned on the surface of the neck that corresponds to the position of the left cervical branch of the vagus nerve, over the carotid pulse just medial to the sternocleidomastoid muscle (Molero-Chamizo et al., 2022) using a biphasic, asymmetrical waveform with a pulse duration that is less than 250 microseconds and a frequency of 20 hertz. Intensity is adjusted according to the sensory threshold level of each patient, each session lasts for 30 minutes (Kutlu et al., 2020). All patients will receive 3 sessions per week for a total of 12 sessions, The sessions will be carried on at Department of Rheumatology and Rehabilitation, Cairo University Hospital
干预措施: Vagus nerve stimulation (Device)
2 Medical treatment
This group will receive medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.
干预措施: Medical treatment (Drug)
3 Combined vagus nerve stimulation and medical treatment
This group will receive cervical t-VNS in the same protocol like the vagus nerve stimulation group, in addition to medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.
干预措施: Combined vagus nerve stimulation and medical treatment (Combination Product)
结局指标
主要结局
Fibromyalgia severity scale
时间窗: 2 months
Is the sum of both widespread pain index, and symptom severity scale score. A decrease in value means improvement
Symptom severity scale score
时间窗: 2 months
A 0-12 score denoting the severity of symptoms. decrease in the score means improvement.
Widespread pain index
时间窗: 2 months
A 0 - 19 score denoting the number of areas the patient has had pain over the last week. decrease in value means improvement.
Visual analogue scale 0-10
时间窗: 2 months
A 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme "worst pain imaginable". decrease i scale means improvement
Visual analogue scale 0-10
时间窗: 0,1,2 months
A 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme "worst pain imaginable". decrease i scale means improvement
Symptom severity scale score
时间窗: 0,1,2 months
A 0-12 score denoting the severity of symptoms. decrease in the score means improvement.
Widespread pain index
时间窗: 0,1,2 months
A 0 - 19 score denoting the number of areas the patient has had pain over the last week. decrease in value means improvement.
Fibromyalgia severity scale
时间窗: 0,1,2 months
Is the sum of both widespread pain index, and symptom severity scale score. A decrease in value means improvement
Fibromyalgia impact questionnaire
时间窗: 0,1,2 months
The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item, that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being in fibromyalgia patients.
次要结局
- Beck depression inventory(2 months)
- Pittsburgh sleep quality index(2 months)
- Beck anxiety scale(2 months)
- Beck anxiety scale(0,1,2 months)
- Beck depression inventory(0,1,2 months)
- Pittsburgh sleep quality index(0,1,2 months)
研究者
Hadeel Ali Ramadan Moustafa Elegily
Principal ivestigator
Kasr El Aini Hospital