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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06482021
Enrollment
80
Registered
2024-07-01
Start date
2024-07-10
Completion date
2024-10-01
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

Acetylcholine iontophoresis, shockwave

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.

Interventions

DEVICELow-intensity extracorporeal shock wave

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.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

the study will be designed to compare the effect of extracorporeal shock wave therapy and acetylcholine iontophoresis on microcirculation changes as a possible new therapy for type 2 diabetic peripheral neuropathy.

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026