Low Level Laser Versus Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy
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
- assessment of change of vascular blood flow
研究概览
简要总结
To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy
详细描述
Diabetic polyneuropathy is a prevalent and severe diabetes-related complication linked to cardiovascular mortality and disease events, even after accounting for risk factors and diabetes status.
Diabetic polyneuropathy affects the peripheral nervous system, leading to dysfunctions in sensory, motor, and autonomic nervous systems. It predisposes diabetics to refractory neuropathic pain, foot ulcers, and amputation, lowering quality of life, increasing mortality, and prompting patients with diabetes to seek medical attention.
Over half of diabetes patients experienced painful diabetic polyneuropathy over the past few decades Painful diabetic polyneuropathy therapy uses various drugs for symptom relief, but they often have systemic side effects and do not slow neuropathy progression. Therefore, investigating non-pharmacological interventions like low-level laser and transcutaneous auricular vagus nerve stimulation is crucial for developing more effective and potentially safer pain management options.
low-level laser therapy and transcutaneous auricular vagus nerve stimulation are emerging non-invasive interventions that have shown potential in alleviating pain associated with diabetic polyneuropathy, a common diabetes complication affecting quality of life.
The effectiveness of conservative treatment options for painful diabetic polyneuropathy needs further investigation. If one method proves superior in reducing pain, improving macrovascular health, and quality of life, it could guide clinical decisions
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
- •The patient selection will be according to the following criteria:
- •30 patients diagnosed with diabetic neuropathy from both genders their ages will be ranged from 45-60 years old.
- •All patients are ambulant independently.
- •All patients are under full medical control
- •Glycated hemoglobin is ranged from 6.5: 7 %.
- •Patients have had diabetes for more than 5 or 10 years.
- •patients experiencing painful peripheral neuropathic symptoms for more than 6 months involving both lower extremities and complained of burning pain with paresthesia in both legs.
- •7 Neurological examination revealed abnormal sensation appeared at the ends of the extremities.
排除标准
- •Patients had unstable glycemic control and/or medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, peripheral vascular diseases, vascular insufficiency (claudication, skin discoloration, ulceration).
- •Following the implantation of cardiac pacemakers or other electrical stimulation devices.
- •Patient had sinus bradycardia, long QT syndrome, or other arrhythmias or mental disorders.
- •Patients whose heart rate dropped below 50 beats/min after vagus nerve stimulation.
- •Nerve damage as a result of prior reconstructive or replacement knee surgery, back surgery, spinal stenosis, spinal compression or radiculopathy
研究组 & 干预措施
Low Level Laser
Patients will receive Low Level Laser irradiated with two wavelengths of visible 630 nm and near infra-red 810 nm for 15 min on entire surface of each foot three times a week for 2 months
干预措施: Low level laser (Device)
Transcutaneous auricular Vagus nerve stimulation
Patients will receive 30 minutes Transcutaneous auricular Vagus nerve stimulation 3 sessions per week for 2 months.
干预措施: Transcutaneous auricular Vagus nerve stimulation (Device)
结局指标
主要结局
assessment of change of vascular blood flow
时间窗: at baseline and after 8 weeks
The study uses Duplex Doppler ultrasound to assess vascular changes in the posterior tibial and anterior tibial, assessing anteroposterior diameter, Tunica intima thickness, and resistive index and peak systolic velocity using a variable frequency range.
次要结局
- Assessment of change of Neuropathic Pain(at baseline and after 8 weeks)
- Assessment of change of Quality of life(at baseline and after 8 weeks)
研究者
Manar Elbaz
Principal Investigator
Horus University