Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of pain intensity
研究概览
简要总结
To evaluate the efficacy of vagus nerve stimulation in reducing neuropathic pain, symptom severity, electrophysiological studies and functional outcomes in patients with diabetic peripheral neuropathy.
详细描述
Diabetes is a major global health problem affecting half a billion people worldwide. Its global prevalence is rising at an alarming rate and has been forecast to reach 700 million by 2045. Diabetic neuropathy is an important and common complication of diabetes, with a lifetime prevalence of more than 50% among people with diabetes. Diabetic neuropathy is an insidious and often disabling disease.
Sensory symptoms are diverse, ranging from numbness to dysesthesia, pain and allodynia, and typically begin in the feet and spread proximally. Motor function can also be affected, preventing patients from engaging in activities of daily living. More recently, the considerable psychosocial and quality of life impacts of Diabetic neuropathy have been recognized. Furthermore, Diabetic neuropathy is a major risk factor for diabetic foot ulceration, which is an independent risk factor for lower limb amputation and mortality. The associated economic burden is high; the annual cost of managing Diabetic neuropathy exceeds billions of dollars in different countries .
Current treatments are purely symptomatic and the most commonly recommended first-line agents include anticonvulsants (gabapentin and pregabalin), serotonin-noradrenaline reuptake inhibitors, and tricyclic antidepressants. Unfortunately, the therapeutic effect may offset by intolerable adverse effects.
In this study, evidence for a potentially effective, non-pharmacological treatment option for Diabetic neuropathy will be provided. Positive findings could lead to improved management strategies for Diabetic neuropathy, reducing the burden of chronic pain and enhancing the overall well-being of diabetic patients. Vagus nerve stimulation has emerged as a potential intervention, offering promise in modulating neuropathic pain and improving functional outcomes.
Furthermore, understanding the mechanisms through which transcutaneous Vagus nerve stimulation affects pain and nerve function may offer insights into broader applications of vagus nerve stimulation in other neuropathic conditions. This research could pave the way for future studies and clinical applications, positioning transcutaneous Vagus nerve stimulation as a valuable tool in the multidisciplinary approach to managing diabetic peripheral neuropathy.
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)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thirty patients diagnosed with diabetic neuropathy of both genders.
- •Age range between 45 and 60 years.
- •Presence of numbness and/or pain in the feet with no other identifiable cause.
- •Pain characterized as stabbing, electric shock-like, or burning in nature.
- •Presence of glove-stocking sensory changes and abnormal sensations in the distal lower limbs.
- •Ability to ambulate independently without assistance.
- •Patients under full medical control.
- •Hemoglobin A1c levels ranging from 6.5% to 7%.
- •History of diabetes mellitus for more than 5 years.
排除标准
- •Implantation of cardiac pacemakers or other electrical stimulation devices.
- •Presence of sinus bradycardia, sick sinus syndrome, or other cardiac arrhythmias.
- •Lumbar radiculopathy.
- •Psychiatric or mental disorders or history of seizures.
- •Visual or auditory impairments or tremors affecting balance.
- •Presence of other neuromuscular disorders.
- •Foot deformities or active foot ulcers.
- •History of lower limb surgical operations.
研究组 & 干预措施
Transcutaneous Vagus nerve stimulation
Patients will receive the same traditional physical therapy as in traditional physical therapy group in addition to 30 min of transcutaneous auricular vagus nerve stimulation 5 sessions per week for 6 weeks.
干预措施: Conventional physical therapy program (Other)
Transcutaneous Vagus nerve stimulation
Patients will receive the same traditional physical therapy as in traditional physical therapy group in addition to 30 min of transcutaneous auricular vagus nerve stimulation 5 sessions per week for 6 weeks.
干预措施: Transcutaneous auricular vagus nerve stimulation (Device)
traditional physical therapy
Patients will receive 30 min of traditional physical therapy, and 30 min of placebo Non-Invasive vagus nerve stimulation, 5 sessions per week for 6 weeks
干预措施: Conventional physical therapy program (Other)
traditional physical therapy
Patients will receive 30 min of traditional physical therapy, and 30 min of placebo Non-Invasive vagus nerve stimulation, 5 sessions per week for 6 weeks
干预措施: Sham therapy (Device)
结局指标
主要结局
Assessment of pain intensity
时间窗: at baseline and after 6 weeks.
The Neuropathic Pain Questionnaire-Short Form consists of 3 items assessing tingling pain, numbness, and increased pain due to touch. Patients rate each item on a scale from 0 (no pain) to 100 (worst imaginable pain/greatest intensity). translated version of Neuropathic Pain Questionnaire-Short Form is reliable and valid for use, to evaluate and diagnose neuropathic pain among Arabic-speaking patients
次要结局
- assessment of sensory nerve action optential.(at baseline and after 6 weeks.)
- assessment of sensory nerve conduction velocity of lower limb(at baseline and after 6 weeks.)
- assessment of Sensory distal latency of lower limb(at baseline and after 6 weeks.)
- assessment of lower limb functional scale(at baseline and after 6 weeks.)
- assessment of motor nerve conduction velocity of lower limb(at baseline and after 6 weeks.)
- assessment of motor distal latency(at baseline and after 6 weeks.)
- assessment of motor nerve action optential.(at baseline and after 6 weeks.)
研究者
Hoda Mamdouh Nematallah
principal investigator
Cairo University