Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback (FREMS)in Patients With Diabetic Neuropathy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Daytime and night-time pain scores assessed at baseline, after FREMS/placebo, and 4 month follow-up
Secondary Outcomes
- 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