Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Shock Wave and Nitric Oxide
- Sponsor
- South Valley University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- • Numerical Rating Pain Scale
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ibrahim Abuzaid
Head of the Department of Physiotherapy for Cardiovascular/ Rspiratory disorder and Geriatrics
South Valley University
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.
Outcomes
Primary Outcomes
• Numerical Rating Pain Scale
Time Frame: 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.
• Nitric oxide level and electrophysiological investigations of peripheral nerves and muscles was measured pre and post treatment.
Time Frame: 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.