NCT00337324

Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 38 (planned)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DEVICE	Frequency-modulated electromagnetic neural stimulation

Timeline

• Start date: 2002-03-01
• Completion: 2004-05-01
• First posted: 2006-06-15
• Last updated: 2006-06-15

Locations

1 site across 1 country: Italy