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

South Valley University

Status: Not yet enrolling

Conditions: Diabetic Nephropathy

Treatments: Device: Low-intensity extracorporeal shock wave

Study type: Interventional

Funder types: Other

Identifiers

NCT06482021

Comparative Study

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Study group (A) Low-intensity shock wave group

Experimental group

Description:

Study group A will receive low-intensity extracorporeal shock wave therapy Li-ESWT (3 Hz, 0.09 mJ/mm2, 300 pulses), for two sessions per week for six weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment.

Treatment:

Device: Low-intensity extracorporeal shock wave

Study group (B) Acetylcholine iontophoresis group

Experimental group

Description:

Study group (B) will receive 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 six weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment.

Treatment:

Device: Low-intensity extracorporeal shock wave