Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: Results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial

E. Bosi; G. Bax; L. Scionti; V. Spallone; S. Tesfaye; P. Valensi; D. Ziegler

doi:10.1007/s00125-012-2795-7

Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: Results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial

E. Bosi, G. Bax, L. Scionti, V. Spallone, S. Tesfaye, P. Valensi, D. Ziegler

IRCCS Ospedale San Raffaele

Research output: Contribution to journal › Article › peer-review

Abstract

Aims/hypothesis: The aim was to evaluate the efficacy and safety of transcutaneous frequency-modulated electromagnetic neural stimulation (frequency rhythmic electrical modulation system, FREMS) as a treatment for symptomatic peripheral neuropathy in patients with diabetes mellitus. Methods: This was a double-blind, randomised, multicentre, parallel-group study of three series, each of ten treatment sessions of FREMS or placebo administered within 3 weeks, 3 months apart, with an overall follow-up of about 51 weeks. The primary endpoint was the change in nerve conduction velocity (NCV) of deep peroneal, tibial and sural nerves. Secondary endpoints included the effects of treatment on pain, tactile, thermal and vibration sensations. Patients eligible to participate were aged 18-75 years with diabetes for ≥1 year, HbA_1c

Original language	English
Pages (from-to)	467-475
Number of pages	9
Journal	Diabetologia
Volume	56
Issue number	3
DOIs	https://doi.org/10.1007/s00125-012-2795-7
Publication status	Published - Mar 2013

Keywords

Diabetic neuropathy
Electrical stimulation
Nerve conduction studies
Neuropathic pain
Neurostimulation therapy
Randomised clinical trial

ASJC Scopus subject areas

Internal Medicine
Endocrinology, Diabetes and Metabolism

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Bosi, E., Bax, G., Scionti, L., Spallone, V., Tesfaye, S., Valensi, P., & Ziegler, D. (2013). Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: Results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial. Diabetologia, 56(3), 467-475. https://doi.org/10.1007/s00125-012-2795-7

Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy : Results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial. / Bosi, E.; Bax, G.; Scionti, L.; Spallone, V.; Tesfaye, S.; Valensi, P.; Ziegler, D.

In: Diabetologia, Vol. 56, No. 3, 03.2013, p. 467-475.

Research output: Contribution to journal › Article › peer-review

Bosi, E, Bax, G, Scionti, L, Spallone, V, Tesfaye, S, Valensi, P & Ziegler, D 2013, 'Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: Results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial', Diabetologia, vol. 56, no. 3, pp. 467-475. https://doi.org/10.1007/s00125-012-2795-7

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abstract = "Aims/hypothesis: The aim was to evaluate the efficacy and safety of transcutaneous frequency-modulated electromagnetic neural stimulation (frequency rhythmic electrical modulation system, FREMS) as a treatment for symptomatic peripheral neuropathy in patients with diabetes mellitus. Methods: This was a double-blind, randomised, multicentre, parallel-group study of three series, each of ten treatment sessions of FREMS or placebo administered within 3 weeks, 3 months apart, with an overall follow-up of about 51 weeks. The primary endpoint was the change in nerve conduction velocity (NCV) of deep peroneal, tibial and sural nerves. Secondary endpoints included the effects of treatment on pain, tactile, thermal and vibration sensations. Patients eligible to participate were aged 18-75 years with diabetes for ≥1 year, HbA1c ",

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