Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy
ConditionDiabetic Neuropathies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-65
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Diagnosis of diabetes based on World Health Organization (WHO) with ages from 55to 65years 2. BMI> 25kg/m2 3. Clinically diagnosed with diabetic neuropathy. 4. All patients are taking oral hypoglycemic drugs with controlled diabetes mellitus.
Disqualifiers
1. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.
Trial design
Design model
Parallel
Treatments tested in this trial
experimental group
DeviceThis 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
DeviceThis 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: experimental groupExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
nerve conduction velocity
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.
Time frame
10 weeks2
Electromyography
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
Time frame
10 weeksSecondary outcomes
1
Google Fit
Google Fit is a mobile application developed by Google that focuses on tracking and monitoring physical activity and overall fitness. It is designed to help users lead healthier lifestyles by providing them with tools to set fitness goals, track their activity levels, and monitor their progress over time
Time frame
10 weeks2
Manage My Pain
Manage My Pain is a mobile application designed to assist individuals in tracking and managing chronic pain. It provides a comprehensive set of tools for users to monitor pain levels, treatments, and overall well-being. The app allows users to record detailed information about their pain, including intensity, location, triggers, and associated symptoms
Time frame
10 weeks3
PEDIS Score Diabetes App
PEDISScore is a mobile application developed for the assessment of diabetic neuropathy, a common complication of diabetes that affects the nerves. It is designed to assist healthcare professionals in evaluating the severity of diabetic neuropathy and monitoring its progression over time. The app utilizes the PEDISScore system
Time frame
10 weeksSponsors and contacts
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Source ClinicalTrials.gov