Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy - Full Text View

Sponsors and Collaborators:	IRCCS San Raffaele Lorenz Biotech University Of Perugia
Information provided by:	IRCCS San Raffaele
ClinicalTrials.gov Identifier:	NCT00337324

Purpose

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

Condition	Intervention	Phase
Painful Diabetic Neuropathy	Device: Frequency-modulated electromagnetic neural stimulation	Phase II Phase III

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy

Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	38
Study Start Date:	March 2002
Estimated Study Completion Date:	May 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337324

Locations

Italy, (Mi)
San Raffaele Hospital and Scientific Institute
Milano, (Mi), Italy, 20132

Sponsors and Collaborators

IRCCS San Raffaele

Lorenz Biotech

University Of Perugia

Investigators

Principal Investigator:

Emanuele Bosi, MD

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

More Information

Publications of Results:

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 2005 Apr 15.

Publications indexed to this study:

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. Epub 2008 Apr 10.

Study ID Numbers:	LORENZ/01
Study First Received:	June 14, 2006
Last Updated:	June 14, 2006
ClinicalTrials.gov Identifier:	NCT00337324
Health Authority:	Italy: Ministry of Health

Keywords provided by IRCCS San Raffaele:

Diabetic neuropathy
Complications of diabetes
Neuropathies
Electromagnetic stimulation
Neuropathic pain

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009