The Effect of Neurostimulation on Patient Relevant Outcomes in Patients With Intermittent Claudication: a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Maximal walking distance determined from the six-minute walk test
研究概览
简要总结
Intermittent claudication is a condition where a patient suffers with cramp-like pain experienced in the muscles of the legs (often the calf muscles) brought on by walking and relieved by stopping walking and resting. It is caused by furring of the arteries (atherosclerosis) often referred to as a circulation problem. It has a significant effect on a sufferers' quality of life. However, in 75% of patients with this condition, the leg symptoms will either stay static or improve slightly even with no treatment. The first line treatment is enrolment in an exercise / walking programme but these are not widely available on the NHS. Failing this, minimally invasive treatment - opening up the narrowing of the artery with either a balloon or stent - can be performed but they are not without risk (being an invasive treatment) and the narrowing often reoccurs in time. Due to the benign natural history of the leg, surgery is less frequently being used. This therefore leaves us with a large number of patients with symptoms with no treatment options and thus a poorer quality of life. Neurostimulation has been used to treat a number of neurological conditions. This study will use a specific device that is attached to the outer aspect of the ear to deliver a neurostimulation to a small branch of the Vagus nerve which through nerve pathways that course through the brain is believed to improve the blood supply to the lower legs.
详细描述
Lower limb peripheral arterial disease (PAD) is common, affecting over 200 million people worldwide and present in 12 to 14% of the global population (20% over the age of 75 years)1. The most common symptom is intermittent claudication, a symptom of muscular lower limb pain brought on by exertion and relieved by rest2.
PAD is the third leading cause of atherosclerotic cardiovascular morbidity, following coronary artery disease and stroke, yet the natural history of the limb in patients with IC is relatively benign with 75% of patients finding that symptoms either remain static or are somewhat improved with no treatment2. It is due to this natural history of the limb that there is an increasing tendency to manage patients with claudication conservatively (ie. Non-invasively).
In patients with intermittent claudication, CV prevention and exercise training are the cornerstones of management3. There is good evidence for enrolment of patients into a supervised exercise programme, providing bot improved walking distance and quality of life, yet widespread provision of such programmes are currently not available within the NHS and further are unlikely to be delivered within the coming years4.
Revascularisation has historically been indicated if daily life activity is severely compromised by the lower limb symptoms and such revascularisation is primarily performed endovascularly with balloon angioplasty +/- stent insertion where needed. The ability to perform endovascular revascularisation is determined by the anatomical location and severity of the lower limb atherosclerosis. Endovascular interventions work best with short focal stenoses rather than longer occlusion where surgical revascularisation is the better option2. Such interventions are invasive and carry risks including risk of amputation and so surgical revascularisation is now rarely performed for intermittent claudication. Further, there is now data available that suggests that early invasive revascularisation in patients with claudication may in the longer term increase the risk of major limb amputation. This means that there is a cohort of patients who have significant claudication symptoms affecting their quality of life who are either (i) not offered revasculairsation or (ii) not prepared to accept the risks of major lower limb revascularisation.
Given this, there is a need to explore further non-invasive methods that could enhance walking distances in patients with IC and thus improve overall quality of life and overall cardiovascular fitness without exposing patients to invasive revascularisations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Rutherford b/c intermittent claudication with stable symptoms for 6 months with a decision not to undergo any revascularization.
排除标准
- •• Critical limb ischaemia
- •Previous external ear surgery
- •Patients with either a cochlear implant or a permanent pacemaker / cardiac defibrillator device
- •Significant cardiorespiratory or musculoskeletal disease (as determined by the medical team) that would contraindicate a 6-minute walk test
结局指标
主要结局
Maximal walking distance determined from the six-minute walk test
时间窗: At baseline and at 8 weeks
Maximal walking distance determined from the six-minute walk test (6MWT)
次要结局
- Quality of life analysis using both generic and disease specific quality of life(At baseline and at 8 weeks)
- Patient acceptance of the neurostimulator device(At baseline and at 8 weeks)