High-Intensity Peripheral Magnetic Stimulation in Traumatic Peripheral Nerve Injury

NCT07705490 | Not Yet Recruiting

• 1 other identifier: AEŞH-EK-2026-112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Peripheral Magnetic Stimulation; High-Intensity Magnetic Stimulation; Neuropathic Pain; Nerve Injury; Rehabilitation; Electrophysiology; Sham-Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, week 4, and week 8

Secondary Outcomes (9)

• Change in Neuropathic Pain Assessed by Douleur Neuropathique 4 (DN4)

  Baseline, week 4, and week 8

• Change in Pain Severity and Interference Assessed by Brief Pain Inventory (BPI)

  Baseline, week 4, and week 8

• Change in Health-Related Quality of Life Assessed by Nottingham Health Profile (NHP)

  Baseline, week 4, and week 8

• Change in Muscle Strength Assessed by Manual Muscle Testing (MRC Scale)

  Baseline, week 4, and week 8

• Change in Compound Muscle Action Potential (CMAP) Amplitude

  Baseline, week 4, and week 8

Study Arms (2)

Active PMS plus Therapeutic Exercise

EXPERIMENTAL

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.

Device: High-Intensity Peripheral Magnetic Stimulation; Other: Therapeutic Exercise Program

Sham PMS plus Therapeutic Exercise

SHAM COMPARATOR

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.

Device: Sham Peripheral Magnetic Stimulation; Other: Therapeutic Exercise Program

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).

Active PMS plus Therapeutic Exercise

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).

Sham PMS plus Therapeutic Exercise

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.

Active PMS plus Therapeutic Exercise; Sham PMS plus Therapeutic Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Douleur Neuropathique 4 (DN4) score ≥ 4
• Visual Analog Scale (VAS) score ≥ 4
• Manual Muscle Testing score \< 5
• No analgesic use, or stable analgesic therapy for the past month (no dose changes)

You may not qualify if:

• 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
• Non-traumatic causes of neuropathy (e.g., radiculopathy, diabetic neuropathy, entrapment neuropathies, HIV-related neuropathy, trigeminal neuralgia)
• Complete nerve injury
• Injury involving three or more peripheral nerves or plexus injury
• History of peripheral nerve surgery or injection within the past 3 months
• Active psychiatric illness
• Coagulopathy

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• Kulchitskaya, D. B., Fesyun, A. D., Yurova, O. V., Konchugova, T. V., Yakovlev, M. Y., Apkhanova, T. V., ... & Kudryavtsev, A. E. (2023). High-intensity pulsed magnetotherapy in the rehabilitation programme of patients with chemotherapy-induced peripheral polyneuropathy: a prospective randomized clinical study. Bulletin of Rehabilitation Medicine, 22(5), 72-82.

  BACKGROUND

• Brown L, Gage E, Cordner H, Kapural L, Rosenberg J, Bedder M. Safety and Efficacy of Magnetic Peripheral Nerve Stimulation for Treating Painful Diabetic Neuropathy. Neuromodulation. 2025 Dec;28(8):1366-1373. doi: 10.1016/j.neurom.2025.03.074. Epub 2025 Apr 30.

  PMID: 40304652 BACKGROUND

• Kapural L, Patel J, Rosenberg JC, Li S, Amirdelfan K, Bedder M. Safety and Efficacy of Axon Therapy (SEAT Study), Utilizing Magnetic Peripheral Nerve Stimulation (mPNS) for Treatment of Neuropathic Pain. J Pain Res. 2024 Sep 28;17:3167-3174. doi: 10.2147/JPR.S481944. eCollection 2024.

  PMID: 39359387 BACKGROUND

MeSH Terms

Conditions

Peripheral Nerve Injuries; Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nurdan Korkmaz

  Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hüseyin Anıl İnan, MD

CONTACT

+905346159274; dranilinan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors (including the electroneurophysiologist) were blinded to group allocation. The physiotherapist delivering the intervention was aware of allocation but did not participate in outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)