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Not yet recruitingNCT06482021Updated Jul 1, 2024

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

An interventional study of Low-intensity extracorporeal shock wave in Diabetic Nephropathy, sponsored by South Valley University. Not yet recruiting. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-01.

Sponsored by South Valley University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Diabetic Nephropathy

Keywords

  • Acetylcholine iontophoresis, shockwave
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In context

Diabetic Neuropathies

617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.

This study's planned enrollment of 80 is close to the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.

Browse Diabetic Neuropathies studies →

Lead sponsor

South Valley University is the lead sponsor of 147 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Study group (A) Low-intensity shock wave group

    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.

    Device: Low-intensity extracorporeal shock wave

  • Experimental
    Study group (B) Acetylcholine iontophoresis group

    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.

    Device: Low-intensity extracorporeal shock wave

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.

    Also known as: Device, ASTAR Swit 33, 43-382 dual-channel Stimulator (Bielsko-Biata, Poland) 230V-, 50/60 HZ, max 70 W, 100VA, was used.

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What researchers measure

Primary outcomes

  1. 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

  1. 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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 35630095 ↗
  • 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. PubMed 34038642 ↗

Individual participant data

Plan to share: Undecided — After publication

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06482021
Lead sponsor
South Valley University
Responsible party
Ibrahim Abuzaid (Director, Head of Department of Physiotherapy for Cardiovascular/Respiratory and Geriatrics, South Valley University) — Principal investigator
First posted
Jul 1, 2024
Start date
Jul 10, 2024 (estimated)
Primary completion
Sep 10, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Jul 1, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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