Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of the study is to monitor the effect of low intensity extracorporeal shock wave therapy on impaired nitric oxide synthase and microcirculation changes in type 2 diabetes mellitus with peripheral neuropathy.

Detailed Description
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Low-intensity extracorporeal shockwave therapy (Li-ESWT) improved peripheral nerve repair and regeneration. Li-ESWT exerts its biological effects by increasing neuro¬trophic factors, Schwann cell activation, and cellular signaling activation. Li-ESWT could be a novel treatment for nerve injury-induced diabetic neuropathy and other conditions related to nerve in¬jury.

Official Title
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Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus

Conditions
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Shock Wave and Nitric Oxide

Intervention / Treatment
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* Device: Low intensity extracorporeal shock wave


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monitor the effect of low intensity extracorporeal shock wave therapy on impaired nitric oxide synthase and microcirculation changes in type 2 diabetes mellitus with peripheral neuropathy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus<br>Energy intensity of (0.09 mJ/mm2) for 12 treatment sessions, two per week, for six weeks | Device: Low intensity extracorporeal shock wave<br>* Extracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean.<br>* Other names: Shock wave;|
| Experimental: Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus<br>low intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of (0.09 mJ/mm2). | Device: Low intensity extracorporeal shock wave<br>* Extracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean.<br>* Other names: Shock wave;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Nitric oxide level and electrophysiological investigations of peripheral nerves and muscles was measured pre and post treatment. | 1. Laboratory methods: Nitric oxide laboratories for measurement of nitric oxide level.3. Electrodiagnostic studies are sensitive, specific, and validated measures of the presence of polyneuropathy. | six weeks | 
| • Numerical Rating Pain Scale | • The Numerical Rating Scale (NRS) is designed for anyone over age 9. It is one of the most commonly used pain scales in health care. To use it, you just say the number that best matches the level of pain you are feeling; you can also place a mark on the scale itself. Zero means you have no pain, while 10 represents the most intense pain possible. | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock Wave, Ntric oxide, Diabetes mellitus, Nerve conduction velocity