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Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

This study has been completed.
Sponsor:
Collaborators:
Lorenz Biotech S.p.A.
University Of Perugia
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00337324
First received: June 14, 2006
Last updated: NA
Last verified: March 2002
History: No changes posted
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy

Resource links provided by NLM:

U.S. FDA Resources

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 23, 2013