Integrating digital health with neuromodulation for diabetic neuropathy
Digital Heath Integration With Neuromodulation Therapies on Sensory and Motor Function in Patients With Diabetic Neuropathy
NA · Cairo University · NCT06670430
This study is testing if a combination of special electrical therapies can help relieve symptoms in older adults with diabetic neuropathy compared to a placebo treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 55 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University (other) |
| Locations | 1 site (Dokki) |
| Trial ID | NCT06670430 on ClinicalTrials.gov |
What this trial studies
This study involves 60 patients aged 55-65 with diabetic neuropathy, randomly assigned to either an experimental group receiving TENS and NMES therapies or a control group receiving placebo treatments. Both groups will also receive standard medical treatment over a 10-week period. The aim is to evaluate the effectiveness of these neuromodulation therapies in alleviating symptoms of diabetic neuropathy. The study will be conducted at Elmahmoudia hospital under the supervision of Cairo University.
Who should consider this trial
Good fit: Ideal candidates are type II diabetic patients aged 55-65 with clinically diagnosed diabetic neuropathy and a BMI over 25.
Not a fit: Patients with other significant neurological or musculoskeletal disorders, severe cognitive impairment, or recent major medical events may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients suffering from diabetic neuropathy.
How similar studies have performed: While the integration of digital health with neuromodulation is a relatively novel approach, similar studies have shown promise in managing neuropathic pain.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dokki
- Faculty of Physical Therapy — Dokki, Egypt (RECRUITING)
Study contacts
- Study coordinator: alaa marzouk, master
- Email: alaamarzouk136@gmail.com
- Phone: 01001346787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Neuropathies