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.
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.
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.
Parallel
Conventional physical therapy program
Other interventionFlexibility 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
DeviceA 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
DeviceThe 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.
Assessment of pain intensity
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
assessment of sensory nerve action optential.
nerve conduction studies is one of the gold standard techniques for diagnosing diabetic poly neuropathy Neuropack Nihon Kohden, Model MEB- 9400, Serial number:00218. (Figure The device is used for electrodiagnosis of diabetic peripheral neuropathy. It is used to measure the sensory nerve action optential.
assessment of sensory nerve conduction velocity of lower limb
nerve conduction studies is one of the gold standard techniques for diagnosing diabetic poly neuropathy Neuropack Nihon Kohden, Model MEB- 9400, Serial number:00218. (Figure The device is used for electrodiagnosis of diabetic peripheral neuropathy. It is used to measure the Sensory conduction velocity
assessment of Sensory distal latency of lower limb
nerve conduction studies is one of the gold standard techniques for diagnosing diabetic poly neuropathy Neuropack Nihon Kohden, Model MEB- 9400, Serial number:00218. (Figure The device is used for electrodiagnosis of diabetic peripheral neuropathy. It is used to measure the Sensory distal latency
assessment of lower limb functional scale
is a widely used patient-reported questionnaire with 20 items to assess difficulty with daily activities due to lower limb problems, scoring from 0 (extreme difficulty) to 4 (no difficulty) for each item, totaling 0-80 points, with higher scores indicating better function.
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