Diabetic Neuropathies
Conditions
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.
Interventions
DEVICEexperimental 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
DEVICEcontrol 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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. 5\. Willingness to comply with the study procedures and interventions. 6. Ability to provide informed consent. 7. presenting with Distal symmetric polyneuropathy (DSPN) based on a score of ≥7 on the validated Michigan Neuropathy Screening Instrument (MNSI) questionnaire. 8\. exhibiting moderately controlled blood pressure
Exclusion criteria
* 1\. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes. 2\. Severe cognitive impairment or inability to provide informed consent. 3. Any recent surgical procedures or major medical events that could affect the study outcomes. 4\. Fracture. 5. Heart Failure. 6. Uncooperative patients. 7. Anemic patient. 8. Patients with liver diseases. 9. Smokers Patients. 10. Any cardiac pacemaker, automatic implantable cardioverter defibrillator (AICD), or other implanted electrical device 11. An existing deep vein thrombosis (DVT) 12. Any metal implants 13. Current foot ulceration or other lower limb skin ulcers 14. Any other cause of neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| nerve conduction velocity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Google Fit | 10 weeks | 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 |
| Manage My Pain | 10 weeks | 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 |
| Electromyography | 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 |
Countries
Egypt
Contacts
STUDY_CHAIRnesreen elnahas, phd
professor
Outcome results
None listed