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

NCT06482021 | Not Yet Recruiting DMC

• 1 other identifier: Comparative Study
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetic Nephropathy

Keywords

Acetylcholine iontophoresis, shockwave

Outcome Measures

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)

  Six weeks

Secondary Outcomes (1)

• Nitric oxide laboratories for measurement of nitric oxide level

  Six weeks

Study Arms (2)

Study group (A) Low-intensity shock wave group

EXPERIMENTAL

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

Study group (B) Acetylcholine iontophoresis group

EXPERIMENTAL

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

Low-intensity extracorporeal shock wave DEVICE

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.

Study group (A) Low-intensity shock wave group; Study group (B) Acetylcholine iontophoresis group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Related Publications (2)

• 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.

  PMID: 35630095 RESULT

• 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.

  PMID: 34038642 RESULT

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Physiotherapy for Cardiovascular/Respiratory and Geriatrics

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: July 1, 2024
• Study Start: July 10, 2024
• Primary Completion: September 10, 2024
• Study Completion: October 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06