Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337324
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : June 15, 2006
Lorenz Biotech S.p.A.
University Of Perugia
Information provided by:
IRCCS San Raffaele

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

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Device: Frequency-modulated electromagnetic neural stimulation Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy
Study Start Date : March 2002
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up

Secondary Outcome Measures :
  1. Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up:
  2. Motor and sensory nerve conduction velocity
  3. Sensory tactile perception by monofilament
  4. Foot vibration perception threshold by biothesiometer
  5. Quality of life by SF-36 instrument
  6. Cutaneous microvascular flow by laser doppler
  7. Partial tissue tension of oxygen and carbon dioxide by oxymetry

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00337324

San Raffaele Hospital and Scientific Institute
Milano, (Mi), Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Lorenz Biotech S.p.A.
University Of Perugia
Principal Investigator: Emanuele Bosi, MD San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milano (Italy)

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00337324     History of Changes
Other Study ID Numbers: LORENZ/01
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: June 15, 2006
Last Verified: March 2002

Keywords provided by IRCCS San Raffaele:
Diabetic neuropathy
Complications of diabetes
Electromagnetic stimulation
Neuropathic pain

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases