Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional physical therapy program, Sham therapy, Transcutaneous auricular vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Transcutaneous Vagal Nerve Stimulation (tVNS), Diabetic Polyneuropathy. Basic parameters: 45 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Diabetes is a major global health problem affecting half a billion people worldwide. Its global prevalence is rising at an alarming rate and has been forecast to reach 700 million by 2045. Diabetic neuropathy is an important and common complication of diabetes, with a lifetime prevalence of more than 50% among people with diabetes. Diabetic neuropathy is an insidious and often disabling disease.
Sensory symptoms are diverse, ranging from numbness to dysesthesia, pain and allodynia, and typically begin in the feet and spread proximally. Motor function can also be affected, preventing patients from engaging in activities of daily living. More recently, the considerable psychosocial and quality of life impacts of Diabetic neuropathy have been recognized. Furthermore, Diabetic neuropathy is a major risk factor for diabetic foot ulceration, which is an independent risk factor for lower limb amputation and mortality. The associated economic burden is high; the annual cost of managing Diabetic neuropathy exceeds billions of dollars in different countries .
Current treatments are purely symptomatic and the most commonly recommended first-line agents include anticonvulsants (gabapentin and pregabalin), serotonin-noradrenaline reuptake inhibitors, and tricyclic antidepressants. Unfortunately, the therapeutic effect may offset by intolerable adverse effects.
In this study, evidence for a potentially effective, non-pharmacological treatment option for Diabetic neuropathy will be provided. Positive findings could lead to improved management strategies for Diabetic neuropathy, reducing the burden of chronic pain and enhancing the overall well-being of diabetic patients. Vagus nerve stimulation has emerged as a potential intervention, offering promise in modulating neuropathic pain and improving functional outcomes.
Furthermore, understanding the mechanisms through which transcutaneous Vagus nerve stimulation affects pain and nerve function may offer insights into broader applications of vagus nerve stimulation in other neuropathic conditions. This research could pave the way for future studies and clinical applications, positioning transcutaneous Vagus nerve stimulation as a valuable tool in the multidisciplinary approach to managing diabetic peripheral neuropathy.
Interventions
- Other 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 - Device 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 flashi - Device 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 participan
Primary outcome measures
- Assessment of pain intensity [Time frame: at baseline and after 6 weeks.]
Secondary outcome measures (7)
- assessment of sensory nerve action optential. [Time frame: at baseline and after 6 weeks.]
- assessment of sensory nerve conduction velocity of lower limb [Time frame: at baseline and after 6 weeks.]
- assessment of Sensory distal latency of lower limb [Time frame: at baseline and after 6 weeks.]
- assessment of lower limb functional scale [Time frame: at baseline and after 6 weeks.]
- assessment of motor nerve conduction velocity of lower limb [Time frame: at baseline and after 6 weeks.]
- assessment of motor distal latency [Time frame: at baseline and after 6 weeks.]
- assessment of motor nerve action optential. [Time frame: at baseline and after 6 weeks.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- outpatient clinic, faculty of physical therapy, Horus university — Damietta
Identifiers
NCT: NCT07405021 · P.T.REC/012/005474