Traumatic peripheral nerve injury is a common cause of chronic neuropathic pain, muscle weakness, and functional limitation, particularly in young and active individuals. Current conservative and pharmacological treatments often provide incomplete relief or carry side effects. High-intensity peripheral magnetic stimulation (PMS) is a non-invasive method that may help reduce neuropathic pain and support motor recovery, but evidence in traumatic nerve injury is limited.
This randomized, double-blind, sham-controlled trial aims to evaluate whether high-intensity PMS, added to a standardized therapeutic exercise program, improves pain, function, quality of life, and electrophysiological measures in adults with traumatic peripheral nerve injury. Participants will be randomly assigned to receive either active PMS or sham PMS, in addition to the same exercise program. Outcomes will be assessed at baseline, 4 weeks, and 8 weeks.
Age between 18 and 65 years
Traumatic peripheral nerve injury
Unilateral traumatic peripheral neuropathy confirmed by electromyography (EMG)
Nerve injury occurring at least 3 months prior
Active infection or malignancy
Metal implant or shrapnel in the application area
Electronic implants (e.g., cardiac pacemaker, spinal cord stimulator, deep brain stimulator)
Central nervous system diseases
Parallel
High-Intensity Peripheral Magnetic Stimulation
DeviceHigh-intensity peripheral magnetic stimulation delivered via an inductive coil placed over the injured peripheral nerve, using a predefined neuropathy protocol (approximately 10 minutes per session, variable frequencies 1-60 Hz). Stimulation intensity is increased until motor activity is elicited and kept constant during the session. Applied 3 times per week for 3 weeks (9 sessions total).
Sham Peripheral Magnetic Stimulation
DeviceSham peripheral magnetic stimulation using the same device, session duration, and application site, with the applicator coil reversed to prevent effective delivery of the magnetic field to the target tissue. Device screen and audible feedback are maintained to preserve blinding. Applied 3 times per week for 3 weeks (9 sessions total).
Therapeutic Exercise Program
Other interventionStandardized individualized therapeutic exercise program including active range of motion exercises, strengthening exercises, stretching exercises, proprioception and balance exercises, and occupational therapy for activities of daily living. Delivered for 20 minutes per day, 5 days per week, over 3 weeks.
Change in Pain Severity Measured by Visual Analog Scale (VAS)
Pain severity assessed using the Visual Analog Scale (VAS), a 0-10 cm scale where 0 indicates "no pain" and 10 indicates "unbearable pain." Higher scores indicate greater pain severity.
Change in Neuropathic Pain Assessed by Douleur Neuropathique 4 (DN4)
Neuropathic pain assessed using the Douleur Neuropathique 4 questionnaire, a 10-item instrument based on patient-reported symptoms and clinical examination findings. Scores range from 0 to 10, with a total score of 4 or higher indicating neuropathic pain. Higher scores indicate a worse outcome.
Change in Pain Severity and Interference Assessed by Brief Pain Inventory (BPI)
Pain severity and pain interference assessed using the Brief Pain Inventory Short Form. Pain severity is scored from 0 to 10 (0 = no pain, 10 = pain as bad as you can imagine) and pain interference is scored from 0 to 10 (0 = does not interfere, 10 = completely interferes) across general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Higher scores indicate a worse outcome.
Change in Health-Related Quality of Life Assessed by Nottingham Health Profile (NHP)
Health-related quality of life assessed using the Nottingham Health Profile. Each of the six sections (pain, physical mobility, energy level, sleep, social isolation, and emotional reactions) is scored from 0 to 100. Higher scores indicate a worse outcome (greater impairment in quality of life).
Change in Muscle Strength Assessed by Manual Muscle Testing (MRC Scale)
Muscle strength assessed by manual muscle testing using the Medical Research Council scale in muscle groups innervated by the affected peripheral nerve. Scores range from 0 (no visible contraction) to 5 (full strength against resistance). Higher scores indicate a better outcome.
Click on the lead sponsor to view all of their trials.
