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 — 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 — OTHERStandardized 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 ExerciseParticipants 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 ExerciseParticipants 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
- Hüseyin Anıl İnan, MD+905346159274
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