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Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

Painful Diabetic Neuropathy Clinical Trial

Official title:
Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00337324
Study type Interventional
Source IRCCS San Raffaele
Contact
Status Completed
Phase Phase 2/Phase 3
Start date March 2002
Completion date May 2004
View Details
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