NMES for DPN: Neuromuscular Electrical Stimulation For The Treatment of Diabetic Peripheral Neuropathy
Study Details
Study Description
Brief Summary
Diabetic peripheral neuropathy (DPN) is the most common complication of diabetes, affecting almost 50% of people with diabetes over the course of their lives. Symptoms vary from numbness to burning, aching and hypersensitivity in the lower limbs, indicative of sensory nerve loss. Motor neurons can also be affected, leading to muscle weakness and mobility issues, thus preventing patients from engaging in daily routines. Further sequelae include foot ulceration and Charcot's neuroarthropathy, which are risk factors for lower limb amputation and mortality. In the United Kingdom, the annual costs of DPN alone exceed £300 million, with further complications expected to cost an additional £1 billion. Currently, management strategies for DPN focus on prophylaxis and pain management. Neuromuscular electrical stimulation (NMES) is a novel nonpharmacological intervention for people with DPN. NMES is the application of electrical impulses which are of sufficiency intensity to improve artificial contraction of the muscle tissue and may help with DPN by improving microvascular blood flow and nerve conductivity by direct stimulation of the nerves.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Control group Best Medical Therapy + Sham Revitive Medic Coach Neuromuscular Electrical Stimulation Device for 6 months |
Device: Sham Revitive Medic Coach (Actegy Ltd)
Use the device for two 30-minute sessions per day, a minimum of five hours per week for 6 months at suprathreshold (2 x motor threshold).
Other Names:
|
| Active Comparator: Intervention group Best Medical Therapy + Revitive Medic Coach Neuromuscular Electrical Stimulation Device for 6 months |
Device: Revitive Medic Coach (Actegy Ltd)
Use the device for two 30-minute sessions per day, a minimum of five hours per week for 6 months at suprathreshold (2 x motor threshold).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Any improvement in nerve conduction parameters of the tested sural, common peroneal, tibial and superficial peroneal nerves measured using a nerve conduction study. [Month 6]
Multi-component, single outcome. Nerve conduction parameters include: Sural: conduction velocity (m/s) - calculated using distance and latency, SNAP amplitude (µV) Common peroneal: conduction velocity (m/s) - calculated using distance and latency, CMAP amplitude (mV), minimum F wave latency (ms) Tibial: conduction velocity (m/s) - calculated using distance and latency, CMAP amplitude (mV), minimum F wave latency (ms) Superficial peroneal: conduction velocity (m/s) - calculated using distance and latency, SNAP amplitude (µV)
Secondary Outcome Measures
- Mobility and balance [Month 6, Month 9]
Berg Balance Scale Questionnaire is a 14-item disease specific questionnaire (scoring up to 56) assessing elements of balance, with each element scoring 0-4.
- Quality of life - EuroQol 5 Domain Quality of Life Questionnaire [Month 6, Month 9]
EuroQol 5 Domain Quality of Life (EQ-5D QOL) questionnaire will provide assessment of the participants quality of life (EQ-5D QOL from 0-1).
- Diabetic neuropathy [Month 6, Month 9]
Michigan Neuropathy Screening Instrument is a patient (15 questions) and clinician (5 questions) completed questionnaire that allows assessment of neuropathy.
- Neuropathy symptoms [Month 6, Month 9]
NTSS-6 Questionnaire is a 6 item questionnaire, scoring a maximum of 3.66 per item with a maximum score of 21.96. This grades neuropathy symptomatology.
- Protected sensation [Month 6, Month 9]
Monofilament test is an objective measurement to assess loss of protective sensation. The 10g monofilament will be perpendicularly applied to five sites (1st, 3rd, and 5th metatarsal heads and plantar surface of the hallux and 3rd toe) of both feet, scoring a maximum of 10.
- Pain [Daily for treatment phase (6 months)]
Daily pain measured using 11-point Numerical Rating Scale (NRS) collected via text message.
- Sleep interference [Daily for treatment phase (6 months)]
Daily Sleep Interference Scale (DSIS) is a 11-point scale collected via text message.
- Cramping [Daily for treatment phase (6 months)]
Daily cramp duration and severity measured using a questionnaire and 11-point Numerical Rating Scale (NRS) collected via text message.
- Any improvement in nerve conduction parameters of the tested sural, common peroneal, tibial and superficial peroneal nerves measured using a nerve conduction study. [Month 9]
Multi-component, single outcome. Nerve conduction parameters include: Sural: conduction velocity (m/s) - calculated using distance and latency, SNAP amplitude (µV) Common peroneal: conduction velocity (m/s) - calculated using distance and latency, CMAP amplitude (mV), minimum F wave latency (ms) Tibial: conduction velocity (m/s) - calculated using distance and latency, CMAP amplitude (mV), minimum F wave latency (ms) Superficial peroneal: conduction velocity (m/s) - calculated using distance and latency, SNAP amplitude (µV)
- Neuromuscular electrical stimulation (NMES) sensation - Intervention group only [Month 6, Month 9]
Assessed using sensory threshold and suprathresholds of NMES device.
- Arterial Blood Flow [Month 6, Month 9]
Arterial blood flow assessed by Duplex Ultrasound (DU), utilising standard haemodynamics assessment, and ankle brachial pressure index.
- Microcirculation [Month 6, Month 9]
Microcirculation assessed by Laser Doppler Flowmetry (LDF).
- Skin oxygenation [Month 6, Month 9]
Skin oxygenation assessed by Trancutaenous Pressure of Oxygen (TcPO2).
- Device experience [Month 6]
Measured using simple questionnaire.
- Compliance with treatment allocations [Month 6]
Measured using Revitive App and patient diary.
Eligibility Criteria
Criteria
INCLUSION CRITERIA
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Aged 18+
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Diagnosis of Type 1 or Type 2 diabetes mellitus and receiving best medical therapy
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Diagnosis of diabetic peripheral neuropathy based on: a validated screening questionnaire Michigan Neuropathy Screening Instrument questionnaire score of ≥ 7 and nerve conduction study of at least one lower limb meet the criteria for mild, moderate or severe DPN based on both sural and common peroneal testing
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Has access to internet at home to use the Revitive App
EXCLUSION CRITERIA
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Lacks capacity to provide informed consent
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Pregnant
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Has an implanted electronic, cardiac or defibrillator device
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Has other cause of peripheral neuropathy (e.g. excessive drinking, low levels of vitamin B12 or other vitamins, syphilis, HIV, underactive thyroid gland)
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Has current foot ulceration
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Has severe vascular disease requiring invasive intervention
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Being treated for, or have the symptoms of, an existing Deep Vein Thrombosis (DVT)
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Already using a neuromuscular electrical stimulation device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Imperial College London | London | United Kingdom | W6 8RF |
Sponsors and Collaborators
- Imperial College London
- Actegy Ltd.
Investigators
- Study Chair: Alun H Davies, MA DM DSC FRCS FEBVS, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18HH4610
- IRAS ID
- NRES REC ID