Painful Diabetic Neuropathy
Conditions
Keywords
Diabetic neuropathy, Complications of diabetes, Neuropathies, Electromagnetic stimulation, Neuropathic pain
Brief summary
We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy.
Detailed description
The stuy was designed as a randomized, double-blind, placebo-controlled cross-over trial. Each patient received two series of ten treatments of either FREMS or placebo in random sequence, with each series lasting no more than three weeks. Primary outcomes (daytime and night-time pain scores) an secondary outcomes (Motor and sensory nerve conduction velocity, sensory tactile perception, foot vibration perception threshold, quality of life, cutaneous microvascular flow, partial tissue tension of oxygen and carbon dioxide) were measured at baseline, after FREMS/placebo series and after 4 months follow-up.
Interventions
DEVICEFrequency-modulated electromagnetic neural stimulation
Sponsors
Lorenz Biotech S.p.A.
University Of Perugia
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* type 1 or type 2 diabetes (American Diabetes Association criteria) * painful diabetic neuropathy with reduced sensory/motor nerve conduction velocity (i.e., \<40 m/sec in at least one nerve trunk of the lower limbs) * vibration perception at the big toe \>25 V
Exclusion criteria
* presence of any concomitant severe disease * pregnancy * renal disease (serum creatinine \>2.0 mg/dL) * history or current foot ulcer * lower limb arterial disease (ankle-brachial index \<0.9) or transcutaneous partial pressure of oxygen \<50 mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor and sensory nerve conduction velocity | — |
| Sensory tactile perception by monofilament | — |
| Foot vibration perception threshold by biothesiometer | — |
| Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up: | — |
| Cutaneous microvascular flow by laser doppler | — |
| Partial tissue tension of oxygen and carbon dioxide by oxymetry | — |
| Quality of life by SF-36 instrument | — |
Countries
Italy
Outcome results
None listed