Diabetic Peripheral Polyneuropathy (Diabetic Neuropathy). Type 2 diabetes mellitus with diabetic polyneuropathy
Conditions
Interventions
Intervention 1: Intervention group: The intervention involves ultrasound-guided injection of a mixture of methylprednisolone (40 mg) and lidocaine 1% (5 ml) around the tibial, sural, and peroneal nerv
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Adults aged 40 years or older. A confirmed diagnosis of Type 2 Diabetes Mellitus for at least 5 years. A confirmed diagnosis of diabetic symmetric sensorimotor polyneuropathy in the lower limbs. Symptom severity must be mild to moderate, as determined by both of the following criteria: a) Clinical assessment: Scoring using the Michigan Neuropathy Screening Instrument. b) Electrophysiological assessment (nerve conduction studies): Presence of findings consistent with axonal neuropathy, such as reduced Nerve Conduction Velocity (NCV) or reduced amplitude of Sensory Nerve Action Potentials (SNAP) and Compound Muscle Action Potentials (CMAP) in at least two nerves. Presence of stable neuropathic symptoms (e.g., pain, tingling, numbness, or burning sensations) for at least the past 6 months. Informed consent. A 4-week stabilization period will be implemented before the start of the study intervention. During this time, all pre-existing treatments for neuropathy (e.g., pain medications like gabapentinoids or antidepressants) must be held at a stable and unchanged dosage.
Exclusion criteria
Exclusion criteria: Patients with severe diabetic polyneuropathy. Presence of other causes of neuropathy (e.g., alcohol-related neuropathy, hereditary neuropathy, neuropathy due to B12 deficiency, or hypothyroidism). Severe comorbid conditions that could interfere with the study outcomes or participant safety, such as: Advanced cardiovascular disease, Severe hepatic or renal impairment/failure. Active foot infection, skin lesion, or ulceration at the proposed injection site. Previous history of surgical nerve decompression in the target area. Known allergy or hypersensitivity to local anesthetics or corticosteroids. History of alcohol or substance abuse. Presence of electrical implants (e.g., pacemaker) that would contraindicate or interfere with electrophysiological studies (e.g., nerve conduction studies). Pregnancy. Breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean of nerve conduction velocity (measured in meters/second) across the tibial, sural, and peroneal nerves. Timepoint: Baseline (pre-intervention) and 6 months post-intervention. Method of measurement: Assessed using electrodiagnostic studies (nerve conduction studies).;Change in pain intensity. Timepoint: Baseline (pre-intervention), 4 weeks, 12 weeks, and 6 months post-intervention. Method of measurement: Mean change in pain score based on the Numerical Rating Scale (NRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in sensory symptoms score. Timepoint: Baseline, 4 weeks, 12 weeks, and 6 months post-intervention. Method of measurement: Change in sensory symptom scores (numbness, tingling, burning) based on the Michigan Neuropathy Screening Instrument. (MNSI questionnaire).;Change in motor function and strength. Timepoint: Baseline, 4 weeks, 12 weeks, and 6 months post-intervention. Method of measurement: Change in lower limb motor function and muscle strength (e.g., ankle dorsiflexion and plantar flexion) graded using the Medical Research Council (MRC) scale.;Improvement in two-point discrimination. Timepoint: Baseline, 4 weeks, 12 weeks, and 6 months post-intervention. Method of measurement: Change in sensory perception measured by the two-point discrimination test on the foot.;Diabetic foot ulcer healing rate. Timepoint: Throughout the 6-month study period. Method of measurement: Time to complete healing or reduction in size of existing diabetic foot ulcers.;Change in lower limb reflexes. Timepoint: Baseline, 4 weeks, 12 weeks, and 6 months post-intervention. Method of measurement: Change in deep tendon reflex scores (e.g., Achilles reflex) using a standardized grading scale (e.g., 0 to 4+).;Improvement in Nerve Conduction Velocity (NCV). Timepoint: Baseline and 6 months post-intervention. Method of measurement: Change in nerve conduction velocity (m/s) of the tibial, sural, and peroneal nerves, assessed by electrophysiological studies.;Patient satisfaction. Timepoint: 12 weeks and 6 months post-intervention. Method of measurement: Level of patient satisfaction measured by a standardized satisfaction survey or Likert scale.;Incidence of adverse events. Timepoint: Throughout the study period (from intervention until end of follow-up). Method of measurement: Number and percentage of patients experiencing intervention-related adverse events (e.g., injection site pain, infection, hemorrhage). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEbrahim Espahbodi
Tehran University of Medical Sciences
Outcome results
None listed