Clinical trial NCT00337324: Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy
Official title: Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Painful Diabetic Neuropathy
Keywords: Diabetic neuropathy
Complications of diabetes
Neuropathies
Electromagnetic stimulation
Neuropathic pain
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Lorenz Biotech S.p.A.
name: University Of Perugia
First posted: 2006-06-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up
Secondary outcomes:
measure: Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up:
measure: Motor and sensory nerve conduction velocity
measure: Sensory tactile perception by monofilament
measure: Foot vibration perception threshold by biothesiometer
measure: Quality of life by SF-36 instrument
measure: Cutaneous microvascular flow by laser doppler
measure: Partial tissue tension of oxygen and carbon dioxide by oxymetry
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Hospital and Scientific Institute
state: (Mi)
Study officials:
affiliation: San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milano (Italy)
name: Emanuele Bosi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.