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

Not Applicable

Not yet recruiting

• Conditions: Diabetic Nephropathy
• Interventions: Device: Low-intensity extracorporeal shock wave

• Registration Number: NCT06482021
• Lead Sponsor: South Valley University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-08
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01
• Study Start: 2024-07-10
• Primary Completion: 2024-09-10
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group (A) Low-intensity shock wave group	Low-intensity extracorporeal shock wave	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.
Study group (B) Acetylcholine iontophoresis group	Low-intensity extracorporeal shock wave	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Nitric oxide laboratories for measurement of nitric oxide level	Six weeks	Nitric oxide laboratories for measurement of nitric oxide level were measured pre and post treatment for both groups.