Digital Heath Integration With Neuromodulation Therapies on Sensory and Motor Function in Patients With Diabetic Neuropathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Neuropathies
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- nerve conduction velocity
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study will be carried out on 60 patients both gender male and female with diabetic neuropathy with age55-65 years. The patients will be selected from Elmahmoudia hospital .patients will be randomly assigned to two groups.
Detailed Description
Experimental Group: This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment. Control Group: This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment.
Investigators
Alaa Mohamed Abdelaty Marzouk
demonstrator
Cairo University
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of diabetes based on World Health Organization (WHO) with ages from 55to 65years
- •BMI\> 25kg/m2
- •Clinically diagnosed with diabetic neuropathy.
- •All patients are taking oral hypoglycemic drugs with controlled diabetes mellitus.
- •Willingness to comply with the study procedures and interventions.
- •Ability to provide informed consent.
- •presenting with Distal symmetric polyneuropathy (DSPN) based on a score of ≥7 on the validated Michigan Neuropathy Screening Instrument (MNSI) questionnaire.
- •exhibiting moderately controlled blood pressure
Exclusion Criteria
- •Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.
- •Severe cognitive impairment or inability to provide informed consent.
- •Any recent surgical procedures or major medical events that could affect the study outcomes.
- •Heart Failure.
- •Uncooperative patients.
- •Anemic patient.
- •Patients with liver diseases.
- •Smokers Patients.
- •Any cardiac pacemaker, automatic implantable cardioverter defibrillator (AICD), or other implanted electrical device
- •An existing deep vein thrombosis (DVT)
Outcomes
Primary Outcomes
nerve conduction velocity
Time Frame: 10 weeks
Adhesive patches called surface electrodes are placed on the skin over nerves or muscles at different spots. A very mild electrical impulse is applied via other patches or a handheld stimulator to stimulate the nerve. The resulting electrical activity of the nerve is recorded by the electrodes. The distance between electrodes and the time it takes for electrical impulses to travel between electrodes are used to measure the speed of the nerve signals. It is normal for several different nerves to be tested.
Electromyography
Time Frame: 10 weeks
An EMG evaluates the electrical activity a muscle produces at rest and when it contracts, similar to an EKG of the heart muscle. The doctor places a single, small, Teflon-coated wire pin into selected muscles to be studied. The tip of the pin acts like an antenna, picking up electrical activity from the muscle that can be heard and seen on a screen. You will be asked to tighten (contract) the muscle. Electrical activity is recorded and can be heard as popping and clicking sounds when the muscle is contracting
Secondary Outcomes
- Google Fit(10 weeks)
- Manage My Pain(10 weeks)
- PEDIS Score Diabetes App(10 weeks)