Control, NMES
Conditions
Keywords
NMES, diabetic peripheral neuropathy
Brief summary
To assess the effect of the device on the progression of diabetic peripheral neuropathy
Detailed description
Diabetes is a metabolic disease that affects the body's ability to control blood sugar levels. This affects the tissues of the body, particularly the walls of blood vessels. People with diabetes are more likely to suffer from ischaemic heart disease, stroke, kidney problems, blindness, foot ulcers, and peripheral nerve problems. Diabetes affects approximately 347 million people worldwide, and by 2030 the WHO projects that complications of diabetes will be the 7th leading cause of death. Peripheral neuropathy is a dysfunction of the nerves most commonly affecting the arms and legs. Diabetes is the leading cause of neuropathy in the Western world, and diabetic neuropathy is estimated to affect between 20-50% of diabetic people. The American Diabetes Association define it as the 'presence of symptoms and signs of peripheral nerve dysfunction in patients with diabetes after exclusion of other causes'. As regards complications of diabetes, peripheral neuropathy has the greatest detrimental effect on quality of life. Diabetic neuropathy is implicated in 50-75% of non-traumatic amputations. The device to be tested mimics the effect of walking by stimulating the motor nerves of the leg, making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. We have seen previous clinical cases of improvement in peripheral neuropathy with use of the device, and wish to formalise the benefits to patients. It is hypothesised to work either by increasing blood flow to the limb and therefore the nerves themselves, or for electrical current to be having a direct effect on the peripheral nervous system itself. The device is easily fitted, can be self-administered by patients, and is suitable for out-patient therapy. We wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic peripheral neuropathy as a therapeutic intervention.
Interventions
DEVICENMES
Application of NMES device bilaterally, once a day, 5 times a week, for 10 weeks
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18+ years old * Diabetes as defined by WHO diagnostic criteria on best medical therapy * Diabetic peripheral polyneuropathy present, confirmed by nerve conduction testing
Exclusion criteria
* Pregnancy * Pacemaker * Metal implants in the legs (below knee)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nerve Conduction Speed (Common Peroneal Nerve) | Baseline, 10 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PAID - Quality of Life Questionnaires | Baseline, 10 weeks | PAID (Problem Areas in Diabetes) is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Treated according to local protocol for diabetic peripheral neuropathy | 5 |
| NMES Treated with neuromuscular stimulation of both legs for 10 weeks | 9 |
| Total | 14 |
Baseline characteristics
| Characteristic | Control | NMES | Total |
|---|---|---|---|
| Age, Continuous | 70.6 years STANDARD_DEVIATION 1 | 65.8 years STANDARD_DEVIATION 1 | 69 years STANDARD_DEVIATION 1 |
| Insulin dependance | 4 participants | 5 participants | 9 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 5 participants | 9 participants | 14 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 8 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 9 |
| other Total, other adverse events | 0 / 5 | 0 / 9 |
| serious Total, serious adverse events | 0 / 5 | 0 / 9 |
Outcome results
Primary
Nerve Conduction Speed (Common Peroneal Nerve)
Time frame: Baseline, 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control (Week 0) | Nerve Conduction Speed (Common Peroneal Nerve) | 33.93 m/sec | Standard Deviation 29.4 |
| Control (Week 10) | Nerve Conduction Speed (Common Peroneal Nerve) | 44.1 m/sec | Standard Deviation 3.2 |
| NMES (Week 0) | Nerve Conduction Speed (Common Peroneal Nerve) | 41.63 m/sec | Standard Deviation 0.5 |
| NMES (Week 10) | Nerve Conduction Speed (Common Peroneal Nerve) | 44.13 m/sec | Standard Deviation 2.8 |
Secondary
PAID - Quality of Life Questionnaires
PAID (Problem Areas in Diabetes) is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress.
Time frame: Baseline, 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control (Week 0) | PAID - Quality of Life Questionnaires | 26.2 score on a scale | Standard Deviation 21.23 |
| Control (Week 10) | PAID - Quality of Life Questionnaires | 27.4 score on a scale | Standard Deviation 21.93 |
| NMES (Week 0) | PAID - Quality of Life Questionnaires | 40.29 score on a scale | Standard Deviation 17.94 |
| NMES (Week 10) | PAID - Quality of Life Questionnaires | 5 score on a scale | Standard Deviation 4.24 |