Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

Phase 2

Completed

• Conditions: Painful Diabetic Neuropathy

• Registration Number: NCT00337324
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Study Timeline

• Status Verified: 2002-03
• Study Start: 2002-03
• Study Completion: 2004-05
• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-14
• Last Update Submitted: 2006-06-14
• Study First Posted: 2006-06-15
• Last Update Posted: 2006-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

San Raffaele Hospital and Scientific Institute; 🇮🇹 Milano, (Mi), Italy