Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

Study Overview
=================
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.

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

Conditions
-----------------
Painful Diabetic Neuropathy

Intervention / Treatment
-----------------
* Device: Frequency-modulated electromagnetic neural stimulation


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Frequency-modulated electromagnetic neural stimulation|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic neuropathy, Complications of diabetes, Neuropathies, Electromagnetic stimulation, Neuropathic pain