Shock Wave and Nitric Oxide
Conditions
Keywords
Shock Wave, Ntric oxide, Diabetes mellitus, Nerve conduction velocity
Brief summary
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
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.
Interventions
DEVICELow intensity extracorporeal shock wave
Extracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean.
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
A group of 80 patients (male and female) diagnosed as type 2 diabetes mellitus, will be included in the study. Their age will be ranged from 40-60 years. Their weight ranged from 80 - 100 k.g. and their height ranged from 160 - 180 cm. Patients will divide into two groups: Study groups (A) 40 patients type 2 diabetes mellitus with clinically proved peripheral neuropathy. And control group (B) 40 patients with asymptomatic type 2 diabetes mellitus. They will be selected from South valley university hospitals. Group A will receive low intensity extracorporeal shock wave therapy for two per week for four weeks. Group B will receive shame low intensity extracorporeal shock wave therapy.
Intervention 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
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
| Measure | Time frame | Description |
|---|---|---|
| • Nitric oxide level and electrophysiological investigations of peripheral nerves and muscles was measured pre and post treatment. | six weeks | 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. |
| • Numerical Rating Pain Scale | six weeks | • 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. |
Countries
Egypt
Contacts
Primary Contactibrahim ismail ibrahim abuzaid, PHD
Backup ContactAdbelrazak Ahmed Abdelrazak Ahmed, PHD
Outcome results
None listed