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 Details — Status: Completed

Administrative data

• NCT number: NCT00337324
• Other study ID #: LORENZ/01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 14, 2006
• Last updated: June 14, 2006
• Start date: March 2002
• Est. completion date: May 2004

Study information

• Verified date: March 2002
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Painful Diabetic Neuropathy

Intervention

Device:
• Frequency-modulated electromagnetic neural stimulation

Locations

Country	Name	City	State
Italy	San Raffaele Hospital and Scientific Institute	Milano	(Mi)

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Lorenz Biotech S.p.A., University Of Perugia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. Epub 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up
Secondary	Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up:
Secondary	Motor and sensory nerve conduction velocity
Secondary	Sensory tactile perception by monofilament
Secondary	Foot vibration perception threshold by biothesiometer
Secondary	Quality of life by SF-36 instrument
Secondary	Cutaneous microvascular flow by laser doppler
Secondary	Partial tissue tension of oxygen and carbon dioxide by oxymetry