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NCT Number: NCT06670430

Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy

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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

55 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Dokki, Egypt

Location status: Recruiting

Location contact

alaa marzouk, master

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • exhibiting moderately controlled blood pressure

Exclusion criteria

  • 1. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.
  • Severe cognitive impairment or inability to provide informed consent. 3. Any recent surgical procedures or major medical events that could affect the study outcomes.
  • 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

Treatment and study plan

Experimental Group

Device

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

Other names: TENS and NMES

Control group

Device

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

Other names: placebo TENS and NMES

Primary outcomes

  1. 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.

  2. 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

  1. Google Fit

    Time frame: 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

  2. Manage My Pain

    Time frame: 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

  3. PEDIS Score Diabetes App

    Time frame: 10 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

alaa marzouk, master

CONTACT

[email protected]

01001346787 ext. 02

marwa mahmoud, phd

CONTACT

[email protected]

01156033818 ext. 02

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Digital Heath Integration With Neuromodulation Therapies on Sensory and Motor Function in Patients With Diabetic Neuropathy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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