Back to results

Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

Primary Purpose

Painful Diabetic Neuropathy

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Frequency-modulated electromagnetic neural stimulation

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Diabetic neuropathy, Complications of diabetes, Neuropathies, Electromagnetic stimulation, Neuropathic pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

San Raffaele Hospital and Scientific Institute

Outcomes

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

Full Information

NCT ID

NCT00337324

First Posted

June 14, 2006

Last Updated

June 14, 2006

Sponsor

IRCCS San Raffaele

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00337324

Brief Title

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

2. Study Status

Record Verification Date

March 2002

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

IRCCS San Raffaele

Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Diabetic Neuropathy

Keywords

Diabetic neuropathy, Complications of diabetes, Neuropathies, Electromagnetic stimulation, Neuropathic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

38 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Frequency-modulated electromagnetic neural stimulation

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Measurements of the following parameters were made at baseline, after FREMS/placebo, and 4 month follow-up:

Title

Motor and sensory nerve conduction velocity

Title

Sensory tactile perception by monofilament

Title

Foot vibration perception threshold by biothesiometer

Title

Quality of life by SF-36 instrument

Title

Cutaneous microvascular flow by laser doppler

Title

Partial tissue tension of oxygen and carbon dioxide by oxymetry

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emanuele Bosi, MD

Organizational Affiliation

San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milano (Italy)

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Raffaele Hospital and Scientific Institute

City

Milano

State/Province

(Mi)

ZIP/Postal Code

20132

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

15834546

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.

Results Reference

result

PubMed Identifier

18403219

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.

Results Reference

derived

Learn more about this trial

Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

We'll reach out to this number within 24 hrs