RecruitingNot ApplicableNCT07405021

Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients

Sponsor

Cairo University

Enrollment

40 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetic Polyneuropathy Transcutaneous Vagal Nerve Stimulation (tVNS)

Summary

To evaluate the efficacy of vagus nerve stimulation in reducing neuropathic pain, symptom severity, electrophysiological studies and functional outcomes in patients with diabetic peripheral neuropathy.

Eligibility

Min Age: 45 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Conventional physical therapy program, a medical device called Sham therapy, and others for people with diabetic polyneuropathy and transcutaneous vagal nerve stimulation (tvns). The study is currently recruiting participants at 1 location. People eligible for this study include aged 45 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERConventional physical therapy program

Flexibility exercises: Gentle passive progressive stretching and self-stretches for lower limbs selected muscles. Muscle strengthening (using a variety of modes as appropriate e.g. isometric, graded weight progression, open and close chain) Aerobic activity. Posture and balance training (for falls prevention and stability). Gait (can improve proprioception and gait pattern in patients with diabetic neuropathy

DEVICESham therapy

A sterile cotton ball will be placed in the ear after sterilizing the cavum conchae and cymba conchae with 75% alcohol. The stimulation electrode will be inserted into the cotton ball, and then the cotton ball will be fixed after ensuring that the stimulator does not touch the skin; the lead wire will be connected. The therapeutic apparatus will be turned on, and the parameters will be the same as those for the transcutaneous vagus nerve stimulation group. All patients will see the lights flashing when the stimulator is running

DEVICETranscutaneous auricular vagus nerve stimulation

The antihelix and cymba concha will be sterilized with 75% alcohol, and then the nerve stimulation electrode (the ear clips) will be attached. The positive pole of the lead will be connected to the antihelix, and the negative pole will be connected to the cymba concha The device parameters include a wave width of 0.2 ms ± 30% and a pulse frequency of 20 Hz. Current intensity will gradually increase to a tolerable level of 4-6 mA, with stimulation lasting for 30 minutes. Heart rates of participants will be monitored continuously, with stimulation ceasing if rates drop below 50 beats per minute. Both the study and control groups will receive the same conventional physical therapy program.