Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

San Donato Group (GSD)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Painful Diabetic Neuropathy

Treatments: Device: Frequency-modulated electromagnetic neural stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00337324

LORENZ/01

Details and patient eligibility

About

We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind