Diabetic Neuropathy, Painful Clinical Trial
Official title:
Long Term, Double Blind, Randomized, Placebo Controlled Multi-center Study of FRE.M.S.- Frequency Modulated Neural Stimulation Lorenz Therapy™ in Symptomatic Diabetic Neuropathy
Aim of this study is to evaluate safety and efficacy of transcutaneous frequency modulated electromagnetic neural stimulation (FREMS) to treat symptomatic peripheral neuropathy in patients with diabetes mellitus.
Diabetic neuropathy is a common and potentially disabling complication of patients with type
1 or type 2 diabetes due to the damage of peripheral nerves caused by chronic hyperglycemia.
The most common clinical signs and symptoms of diabetic neuropathy include numbness,
diminished sensation and painful symptoms, such as burning, pins and needles, intolerable
pain and hyperaesthesia of the lower extremities.
Different classes of drugs, such as analgesics, antidepressants and anti-epileptics are
variably efficacious in pain relief, but are unfortunately unable to revert the natural
history of the disease.
A wide range of electrotherapies have been proposed for the non-pharmacological treatment of
diabetic neuropathy. The rationale of using electric or magnetic stimulation is the
potential enhancement of microcirculation and endoneural blood flow, possibly counteracting
the nerve ischemic damage, together with other yet poorly understood mechanisms, such as
masking pain by interfering with pain gate control.
A number of studies have reported the efficacy of different electrotherapies, such as
transcutaneous electrical nerve stimulation (TENS), pulsed-dose electrical stimulation,
peripheral nerve, nerve root, spinal cord, deep brain and epidural motor cortex
stimulations, pulsed (electro-)magnetic fields and static magnetic fields, high-frequency
external muscle stimulation, high-tone external muscle stimulation and external muscle
stimulation. However, of all these electrotherapies, only TENS is currently recommended as a
treatment for painful diabetic neuropathy by the American Academy of Neurology.
Recently, a novel transcutaneous frequency-modulated electromagnetic neural stimulation
(also named as Frequency Rhythmic Electrical Modulation System, FREMS), has been developed.
FREMS consists of a sequence of modulated electrical stimuli that varies automatically in
terms of pulse frequency, duration and voltage amplitude. FREMS was tested in a pilot
randomized, cross-over study, and reduced diabetic neuropathy pain and ameliorated the
sensory tactile and vibration perception threshold and motor nerve conduction velocity
compared to a sham treatment.
The aim of this study was to test the efficacy and safety of FREMS in a multicentre,
randomized, double-blind, placebo-controlled study enrolling a large population with
symptomatic diabetic polyneuropathy, with repeated treatment sessions and a post-treatment
follow-up of adequate length.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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