Clinical trial NCT06482021: Comparative Effectiveness Of Low Extra-Corporeal Shock Wave Versus Acetylcholine Iontophoresis On Type2 Diabetic Neuropathy
Official title: Comparative Effectiveness Of Low Extra-Corporeal Shock Wave Versus Acetylcholine Iontophoresis On Type2 Diabetic Neuropathy: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Nephropathy
Keywords: Acetylcholine iontophoresis, shockwave
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Electrophysiological investigations of peripheral nerves (latency, amplitude and velocity of peripheral nerves)
timeFrame: Six weeks
Secondary outcomes:
measure: Nitric oxide laboratories for measurement of nitric oxide level
timeFrame: Six weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Chen KT, Chen YP, Kuo YJ, Chiang MH. Extracorporeal Shock Wave Therapy Provides Limited Therapeutic Effects on Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2022 May 19;58(5):677. doi: 10.3390/medicina58050677.
citation: Melese H, Alamer A, Getie K, Nigussie F, Ayhualem S. Extracorporeal shock wave therapy on pain and foot functions in subjects with chronic plantar fasciitis: systematic review of randomized controlled trials. Disabil Rehabil. 2022 Sep;44(18):5007-5014. doi: 10.1080/09638288.2021.1928775. Epub 2021 May 26.