NCT02436200

Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication

Neuromuscular Electrical Stimulation in Patients With Intermittent Claudication

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of lower limb intermittent claudication.

Detailed description

The circulation of blood around the body is dependent on effective pumping of the heart. Patients with claudication experience pain or discomfort in their legs usually during activity such as walking, which goes away at rest. Claudication is a symptom of peripheral arterial disease (PAD). If left untreated, patients can develop arterial insufficiency which can lead to various complications such as swelling, painful legs, reduced healing of injuries and the loss of limbs in extreme conditions. PAD can be defined as a narrowing of the arteries reducing blood flow. It is most commonly due to atherosclerosis, and has associations with heart disease, stroke, and diabetes. Its incidence is estimated at 7-14% in the general population, increasing with age to about 20% in the over-seventies. It is associated with effects on mobility, skin condition and quality of life. Symptoms include pain in the legs on walking (intermittent claudication), pain at rest (particularly at night), gangrene, and limb loss. Management of PAD is based on encouraging exercise, and modification of risk factors such as smoking, high blood pressure, high cholesterol and diabetes. In patients with PAD, exercise tolerance is often limited. Severe symptoms and disease can be treated by procedures such as balloon angioplasty, stenting or surgical bypass, but these procedures have risks. There also remains a percentage of patients who are not suitable for revascularisation, and have few options besides amputation available to them. Some trials have shown that increasing the blood flow in the legs over time using medical devices (intermittent pneumatic compression, muscle stimulators), in addition to maximal medical and surgical therapy, can increase claudication distance, absolute walking distance, decrease rest pain, and reduce amputation rates. In our unit it has become apparent that there are an increasing number of medical devices available for circulatory support, either for use as an inpatient, out-patient, or a member of the general public. The supporting evidence for these is variable in scientific and clinical content or relevance, and requires clinical trials to evaluate further. The device being used in this study, activates the pumping action of the leg muscles by providing neuromuscular electrical stimulation (NMES) to cause foot muscle contraction and relaxation. This squeezes blood back towards the heart, improving circulation. The study will evaluate whether NMES using this device has the same beneficial effects in patients with intermittent claudication.

Conditions

• Intermittent Claudication
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Neuromuscular Electrical Stimulation	Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-05-06
• Last updated: 2020-09-29
• Results posted: 2019-09-20

Locations

1 site across 1 country: United Kingdom