Frequency Rhythmic Electrical Modulated Stimulation Effect in Peripheral Neuropathy Patients Severity of Cases and Qol.
NCT07645482 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-07-21
Summary
It's estimated that 50% of diabetic patients will have peripheral neuropathy as a complication within 3 years of the diabetes incidence \[14\], the goal of the study is to investigate this problem through the following objectives:
1. To measure the effect of using FREMS therapy in diabetic neuropathy in interventional group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.
2. To measure the effect of using standard of care in diabetic neuropathy in control group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.
3. To compare the results between both interventional and control group.
Conditions
- Peripheral Neuropathy With Type 2 Diabetes
Interventions
- DEVICE
-
frequency rhythmic electrical modulated stimulation.
FREMS is characterized by sequences of biphasic electrical stimuli, with 10 consecutive sessions applied on lower limb within 10:14 days, 40 minutes for each session.
- DRUG
-
Duloxetine - low dose
peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.
Sponsors & Collaborators
-
Beni-Suef University
lead OTHER
Principal Investigators
-
Ayman abdallah., phd · Beni-Suef University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- Egypt
Study Locations
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