Diabetic neuropathy (DN) 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 neuroarthropathy, which are risk factors for lower limb amputation and mortality. In the United Kingdom, the annual costs of DN alone exceed £300 million, with further complications expected to cost an additional £1 billion. Currently, management strategies for DN focus on prevention and pain management. Neuromuscular electrical stimulation (NMES) is a novel nonpharmacological intervention for people with DN. NMES is the application of electrical impulses which are of sufficiency intensity to improve artificial contraction of the muscle tissue and may help with DN by improving nerve conductivity through direct stimulation of the nerves.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
65
Use the device for two 30-minute sessions per day, a minimum of five hours per week for 12 weeks at suprathreshold (2 x motor threshold).
Use the device for two 30-minute sessions per day, a minimum of five hours per week for 12 weeks at suprathreshold (2 x motor threshold).
Imperial College London
London, United Kingdom
Primary outcome measure: neuropathy symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part A questionnaire.
Time frame: Week 6, Week 12, Week 26
Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.
Time frame: Pre-screening / Identification, Recruitment and Consent, Baseline
Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.
Time frame: Recruitment and Consent, Baseline, Week 12, Week 26
Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.
Time frame: Week 12
Safety outcome measure: Adverse Events (AEs) collected and reported via AE form.
Time frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Adverse Device Effects (ADEs) collected and reported via AE form.
Time frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Serious Adverse Events (SAEs) collected and reported via SAE form.
Time frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Serious Adverse Device Effects (SADEs) collected and reported via SAE form.
Time frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Secondary outcome measure: sural nerve conductivity measured using a nerve conduction study (central site only).
Nerve conduction parameters include sural nerve conduction velocity (m/s) and SNAP amplitude (µV).
Time frame: Week 12, Week 26.
Secondary outcome measure: superficial peroneal nerve conductivity measured using a nerve conduction study (central site only).
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and latency (ms), and SNAP amplitude (μV).
Time frame: Week 12, Week 26
Secondary outcome measure: common peroneal nerve conductivity measured using a nerve conduction study (central site only).
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and distal latency (ms), Compound Muscle Action Potential (CMAP) amplitude (mV) and minimum F wave latency (ms).
Time frame: Week 12, Week 26
Secondary outcome measure: tibial nerve conductivity measured using a nerve conduction study (central site only).
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and distal latency (ms), Compound Muscle Action Potential (CMAP) amplitude (mV) and minimum F wave latency (ms).
Time frame: Week 12, Week 26
Secondary outcome measure: somatosensory nerve fibre function measured using QuantitativeSensory Testing (QST) (central site only).
Somatosensory nerve fibre function will be assessed using the German Research Network on Neuropathic Pain (DFNS) QST protocol. The battery of tests includes measures of cold and warm detection thresholds, paradoxical heat sensations, cold and heat pain thresholds, mechanical detection threshold, mechanical pain threshold, mechanical pain sensitivity, dynamic mechanical allodynia, temporal pain summation, vibration detection threshold and pressure pain threshold.
Time frame: Week 12, Week 26
Secondary outcome measure: blood glucose measured using HbA1c.
Time frame: Week 12
Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS).
Time frame: Week 12, Week 26
Secondary outcome measure: neuropathy signs measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part B questionnaire.
Time frame: Week 12, Week 26
Secondary outcome measure: symptoms measured using Total Symptom Score (TSS).
Time frame: Week 12
Secondary outcome measure: protected sensation measured using monofilament test.
Time frame: Week 12, Week 26
Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI).
Time frame: Week 12, Week 26
Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold.
Time frame: Week 12, Week 26
Secondary outcome measure: device experience measured using device experience questionnaire.
Time frame: Week 12
Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire.
Time frame: Baseline
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