Vagus nerve stimulation to reduce pain and improve nerve function in diabetic neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Thirty adults with diabetic peripheral neuropathy will be enrolled at the outpatient clinic of the Faculty of Physical Therapy, Horus University (Damietta) and receive either transcutaneous auricular vagus nerve stimulation, sham stimulation, or a conventional physical therapy program. Pain intensity, neuropathic symptom severity, nerve conduction studies, and functional outcome measures will be collected before and after the intervention period. The study compares real stimulation against sham and standard therapy to see whether tVNS provides greater reductions in pain and objective improvements in nerve function. Safety and tolerability, including cardiac contraindications, will also be monitored throughout the protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• outpatient clinic, faculty of physical therapy, Horus university
  Damietta, Egypt Recruiting

Study contacts

• Study coordinator: Hoda Mamdouh nematallah, assisstant lecturer
• Email: hmamdouh@horus.edu.eg
• Phone: 01096551775

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.