Clinical Trial: Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Neuromuscular Electrical Stimulation in Patients With Intermittent Claudication

Brief 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 Summary:

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
Sponsor: Imperial College London

Current Primary Outcome:

• Initial walking distance measured by treadmill [ Time Frame: Change in baseline treadmill walking distance at 6 weeks ]
  For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain.
• Absolute walking distance measured by treadmill [ Time Frame: Change in baseline treadmill walking distance at 6 weeks ]
  For the absolute claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The absolute claudication distance (ACD) is the distance walked before the participant is forced to stop due to typical pain.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Femoral Haemodynamics measured by Femoral artery Duplex Ultrasonography [ Time Frame: Change in baseline femoral haemodynamics at 6 weeks ]
  Ultrasound assessment of blood flow dynamics in the femoral artery will be obtained at rest, and if randomised to the intervention group, whilst using the device.
• Laser Doppler Flow measured by optical laser [ Time Frame: Change in baseline flowmetry at 6 weeks ]
  Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.
• Symptomatic scores by questionnaire [ Time Frame: Change in baseline questionnaire scores at 6 weeks ]
  Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6.
• Quality of Life Scores measured by questionnaire [ Time Frame: Change in baseline quality of life at 6 weeks ]
  Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks.
• Urine metabolic profile [ Time Frame: Change of profile at baseline and at 6 weeks ]
  A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.
• Serum metabolic profile [ Time Frame: Change of profile at baseline and 6 weeks ]
  A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.

Original Secondary Outcome:

• Femoral Haemodynamics measured by Femoral artery Duplex Ultrasonography [ Time Frame: Change in baseline femoral haemodynamics at 6 weeks ]
  Ultrasound assessment of blood flow dynamics in the femoral artery will be obtained at rest, and if randomised to the intervention group, whilst using the device.
• Laser Doppler Flow measured by optical laser [ Time Frame: Change in baseline flowmetry at 6 weeks ]
  Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.
• Symptomatic scores by questionnaire [ Time Frame: Change in baseline questionnaire scores at 6 weeks ]
  Validated questionnaires including the Edinburgh Claudication Questionnaire and Charing Cross Claudication Questionnaire will be obtained at baseline and week 6.
• Quality of Life Scores measured by questionnaire [ Time Frame: Change in baseline quality of life at 6 weeks ]
  Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks.
• Urine metabolic profile [ Time Frame: Change of profile at baseline and at 6 weeks ]
  A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.
• Serum metabolic profile [ Time Frame: Change of profile at baseline and 6 weeks ]
  A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.

Information By: Imperial College London

Dates:
Date Received: April 24, 2015
Date Started: December 2014
Date Completion:
Last Updated: December 1, 2015
Last Verified: August 2015