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Completed

NCT Number: NCT00337324

Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

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

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Key information

Conditions

Painful Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

San Raffaele Hospital and Scientific Institute

Milan, (Mi), 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Frequency-modulated electromagnetic neural stimulation

Device

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • Lorenz Biotech S.p.A.
  • University Of Perugia

Registry information

Official study title

Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy

Important dates

Study start
2002
Study completion
2004
First posted
Jun 15, 2006
Registry last updated
Jun 15, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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