Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

NCT00337324 | Completed Phase 2

• 1 other identifier: LORENZ/01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Painful Diabetic Neuropathy

Keywords

Diabetic neuropathy; Complications of diabetes; Neuropathies; Electromagnetic stimulation; Neuropathic pain

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

• 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

Interventions

Frequency-modulated electromagnetic neural stimulation DEVICE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Lorenz Biotech S.p.A.: collaborator
• University Of Perugia: collaborator

Study Sites (1)

San Raffaele Hospital and Scientific Institute

Milan, (Mi), 20132, Italy

Location

Related Publications (2)

• 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. doi: 10.1007/s00125-005-1734-2. Epub 2005 Apr 15.

  PMID: 15834546 RESULT

• Conti M, Peretti E, Cazzetta G, Galimberti G, Vermigli C, Pola R, Scionti L, Bosi E. Frequency-modulated electromagnetic neural stimulation enhances cutaneous microvascular flow in patients with diabetic neuropathy. J Diabetes Complications. 2009 Jan-Feb;23(1):46-8. doi: 10.1016/j.jdiacomp.2008.02.004. Epub 2008 Apr 10.

  PMID: 18403219 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emanuele Bosi, MD

  San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milano (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 15, 2006
• Study Start: March 1, 2002
• Study Completion: May 1, 2004
• Last Updated: June 15, 2006

Record last verified: 2002-03

Locations

IT (1)