Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

IRCCS San Raffaele38 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Painful Diabetic Neuropathy

Interventions

Frequency-modulated electromagnetic neural stimulationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

San Raffaele Hospital and Scientific Institute

Milan, (Mi), Italy

Outcomes

Primary Outcomes

Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up

Secondary Outcomes

Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up:

Motor and sensory nerve conduction velocity

Sensory tactile perception by monofilament

Foot vibration perception threshold by biothesiometer

Quality of life by SF-36 instrument

Cutaneous microvascular flow by laser doppler

Partial tissue tension of oxygen and carbon dioxide by oxymetry

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.