Actively Recruiting
Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients
Led by Cairo University · Updated on 2026-02-12
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Diabetic peripheral neuropathy is a common and often disabling complication affecting many people with diabetes, characterized by symptoms such as numbness, pain, and sensory changes in the feet that can spread upward. Researchers are evaluating the potential benefits of vagus nerve stimulation to reduce neuropathic pain, improve nerve function, and enhance daily activities in patients aged 45 to 60 with diabetic peripheral neuropathy. This study aims to explore a non-drug treatment option that might improve quality of life and reduce the burden of chronic pain in diabetes. Participants will be randomly assigned to one of two groups. One group will receive traditional physical therapy combined with 30 minutes of transcutaneous auricular vagus nerve stimulation five times per week for six weeks. The other group will receive the same physical therapy along with a placebo sham vagus nerve stimulation for the same duration and frequency. The vagus nerve stimulation involves using a device that delivers mild electrical pulses to specific areas of the ear, with heart rate monitored during sessions to ensure safety. During the study, participants will undergo assessments at the start and after six weeks, including measures of pain intensity, sensory and motor nerve conduction, nerve signal speed and latency in the lower limbs, and functional ability in daily activities. Researchers will monitor safety and treatment effects throughout. The total study participation lasts six weeks, with evaluations focusing on changes in neuropathic pain and nerve function to determine the impact of vagus nerve stimulation.
CONDITIONS
Brief Title
Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with diabetic neuropathy
- Aged between 45 and 60 years
- Experience numbness and/or pain in the feet with no other cause
- Pain described as stabbing, electric shock-like, or burning
- Show glove-stocking sensory changes and abnormal sensations in lower limbs
- Able to walk independently without help
- Under stable medical control
- Hemoglobin A1c between 6.5% and 7%
- Have had diabetes mellitus for more than 5 years
You will not qualify if you...
- Have a cardiac pacemaker or other electrical stimulation devices implanted
- Have sinus bradycardia, sick sinus syndrome, or cardiac arrhythmias
- Have lumbar radiculopathy
- Have psychiatric, mental disorders, or history of seizures
- Have visual or hearing impairments or tremors affecting balance
- Have other neuromuscular disorders
- Have foot deformities or active foot ulcers
- Have had lower limb surgical operations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive 30 minutes of traditional physical therapy and either transcutaneous auricular vagus nerve stimulation or sham stimulation 5 sessions per week for 6 weeks.
5 sessions per week for 6 weeks (in-person)
Duration - Immediately after 6 weeks of treatment
Participants are assessed for pain intensity, nerve conduction, and functional outcomes after completing treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
outpatient clinic, faculty of physical therapy, Horus university
Damietta, Egypt
Actively Recruiting
Research Team
H
Hoda Mamdouh nematallah, assisstant lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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