Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy
June 14, 2006 updated by: IRCCS San Raffaele
Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy
We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
38
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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(Mi)
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Milano, (Mi), Italy, 20132
- San Raffaele Hospital and Scientific Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up
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Secondary Outcome Measures
Outcome Measure |
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Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up:
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Motor and sensory nerve conduction velocity
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Sensory tactile perception by monofilament
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Foot vibration perception threshold by biothesiometer
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Quality of life by SF-36 instrument
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Cutaneous microvascular flow by laser doppler
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Partial tissue tension of oxygen and carbon dioxide by oxymetry
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emanuele Bosi, MD, San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milano (Italy)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Study Completion
May 1, 2004
Study Registration Dates
First Submitted
June 14, 2006
First Submitted That Met QC Criteria
June 14, 2006
First Posted (Estimate)
June 15, 2006
Study Record Updates
Last Update Posted (Estimate)
June 15, 2006
Last Update Submitted That Met QC Criteria
June 14, 2006
Last Verified
March 1, 2002
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LORENZ/01
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