Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy

Cairo University (CU)

Status: Enrolling

Conditions: Diabetic Neuropathies

Treatments: Device: control group; Device: experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT06670430

P.T.REC/012/005260

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

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.

  2. 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.

  3. 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.

  3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

experimental group

Experimental group

Description:

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

Treatment:

Device: experimental group

control group

Placebo Comparator group

Description:

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

Treatment:

Device: control group