High-Intensity Peripheral Magnetic Stimulation in Traumatic Peripheral Nerve Injury

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study ID
NCT07705490
Status
Not Yet Recruiting

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Conditions

  • Neuropathic Pain
  • Peripheral Nerve Injuries
  • Peripheral Nerve Injuries, Traumatic
  • Traumatic Peripheral Nerve Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • High-Intensity Peripheral Magnetic Stimulation — DEVICE
    High-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 — DEVICE
    Sham 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
    Standardized 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.

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active PMS plus Therapeutic Exercise
    Participants receive high-intensity peripheral magnetic stimulation (PMS) applied over the injured peripheral nerve using a predefined neuropathy protocol (approximately 10 minutes per session, variable frequencies 1-60 Hz), for a total of 9 sessions over 3 weeks (3 sessions per week). Stimulation intensity is increased until motor activity is elicited and kept constant during the session. In addition, participants receive a standardized therapeutic exercise program (active range of motion, strengthening, stretching, proprioception and balance exercises, and occupational therapy) for 20 minutes per day, 5 days per week, over 3 weeks.
  • Sham Comparator: Sham PMS plus Therapeutic Exercise
    Participants receive sham peripheral magnetic stimulation using the same device, session duration, and application site, but 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. In addition, participants receive the same standardized therapeutic exercise program (active range of motion, strengthening, stretching, proprioception and balance exercises, and occupational therapy) for 20 minutes per day, 5 days per week, over 3 weeks.

Primary Outcome Measure

Change in Pain Severity Measured by Visual Analog Scale (VAS) [ Time Frame: Baseline, week 4, and week 8 ]

Central Contacts

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