Comparative Effectiveness Of Low Extra-Corporeal Shock Wave Versus Acetylcholine Iontophoresis On Type2 Diabetic Neuropathy

N/AUnknownNCT06482021

South Valley University80 enrolled

Overview

In our thesis, we will compare the effectiveness of low-intensity shock wave versus acetylcholine iontophoresis as a possible new therapy for microcirculation changes in type 2 diabetic neuropathy

Methods: A group of 80 patients (male and female) diagnosed with type 2 diabetes mellitus, was included in the study. Their age ranged from 40-60 years. Patients randomly will be divided into two groups: Study groups (A) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. And study group (B) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. They were selected from South Valley University Hospitals. Group A received low-intensity extracorporeal shock wave therapy Li-ESWT (3 Hz, 0.09 mJ/mm2, 300 pulses), for two sessions per week for six weeks. Study group (B) received iontophoresis by acetylcholine current intensity of 3 to 5 mA. Check skin every 3-5 minutes for signs of skin irritation with (15) min for three sessions per week for four weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Nephropathy

Interventions

Low-intensity extracorporeal shock waveDEVICE

Acetylcholine iontophoresis• The Iontophoresis comprises of electric impulses from a low voltage galvanic current stimulation unit to drive ions (Ach) (1%) into soft tissue structures.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy. * Optimized pharmacological treatment that will be remained unchanged throughout the study. Exclusion Criteria: * Implanted cardiac pacemakers. * Patients with known skin allergies. * Presence of skin inflammations. * Peripheral vascular disease. * Patients with unstable angina pectoris. * Progressive ventricular dysrhythmia. * Intermittent claudication.

Outcomes

Primary Outcomes

Electrophysiological investigations of peripheral nerves (latency, amplitude and velocity of peripheral nerves)

Electrophysiological investigations of peripheral nerves were measured pre and post treatment for both groups (latency, amplitude and velocity of peripheral nerves)

Time frame: Six weeks

Secondary Outcomes

Nitric oxide laboratories for measurement of nitric oxide level

Nitric oxide laboratories for measurement of nitric oxide level were measured pre and post treatment for both groups.

Time frame: Six weeks

Data from ClinicalTrials.gov

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