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

NCT07405021 · tracked via the Priya Life Science Egypt tracker

Sponsor

Cairo University

Phase

Not applicable

Started

2026-01-01

Last updated

2026-02-12

Condition(s) studied

Transcutaneous Vagal Nerve Stimulation (tVNS)Diabetic Polyneuropathy

Investigational drug(s) / intervention(s)

Conventional physical therapy programSham therapyTranscutaneous auricular vagus nerve stimulation

Conventional 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

Sham 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

Transcutaneous 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.

Study 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

Sex

ALL

Min age

45 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria * Thirty patients diagnosed with diabetic neuropathy of both genders. * Age range between 45 and 60 years. * Presence of numbness and/or pain in the feet with no other identifiable cause. * Pain characterized as stabbing, electric shock-like, or burning in nature. * Presence of glove-stocking sensory changes and abnormal sensations in the distal lower limbs. * Ability to ambulate independently without assistance. * Patients under full medical control. * Hemoglobin A1c levels ranging from 6.5% to 7%. * History of diabetes mellitus for more than 5 years. Exclusion Criteria * Implantation of cardiac pacemakers or other electrical stimulation devices. * Presence of sinus bradycardia, sick sinus syndrome, or other cardiac arrhythmias. * Lumbar radiculopathy. * Psychiatric or mental disorders or history of seizures. * Visual or auditory impairments or tremors affecting balance. * Presence of other neuromuscular disorders. * Foot deformities or active foot ulcers. * History of lower limb surgical operations.

Primary outcome measure(s)

Assessment of pain intensity — at baseline and after 6 weeks.
The Neuropathic Pain Questionnaire-Short Form consists of 3 items assessing tingling pain, numbness, and increased pain due to touch. Patients rate each item on a scale from 0 (no pain) to 100 (worst imaginable pain/greatest intensity). translated version of Neuropathic Pain Questionnaire-Short Form is reliable and valid for use, to evaluate and diagnose neuropathic pain among Arabic-speaking patients

Trial sites (1)

Facility	City	Region	Status
outpatient clinic, faculty of physical therapy, Horus university	Damietta	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07405021 on ClinicalTrials.gov ↗ ← All trials in Egypt