NCT04833660

rTMS on Diabetic Peripheral Neuropathic Pain

The Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Min Cheol Chang · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Background: Approximately half of the patients with long-standing diabetes are known to have diabetic peripheral neuropathy (DPN). Pain from DPN deteriorates the quality of life and hinders daily life activities. Objectives: This study aimed to evaluate the effect of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) on the left primary motor cortex (M1) for neuropathic pain in the lower extremities due to DPN. Methods: In this randomized trial, 22 patients with DPN will randomly assign to the rTMS group (10 Hz stimulation, five sessions) or the sham group. A numeric rating scale (NRS) will use to measure pain intensity before treatment and after 1 day and 1 week of the treatment. Physical and mental health status will evaluate using the Short Form 36-Item Health Survey (SF-36), comprising two subscales (physical and mental component scores \[PCSs and MCSs\]), at 1-week post-treatment.

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	repetitive transcranial magnetic stimulation	Repetitive transcranial magnetic stimulation (rTMS) is a safe, noninvasive, and effective therapeutic intervention that uses an electromagnetic coil applied to the scalp to produce a magnetic field. rTMS induces changes in cortical excitability at the stimulation site and transsynaptically at distant areas. Cortical excitability is increased by high-frequency (≥5 Hz) stimulation and is decreased by low-frequency (1 Hz) stimulation. The application of high-frequency unilateral rTMS to the motor cortex in patients is reported to have a potential to control various types of pain, such as neuropathic pain, fibromyalgia, and musculoskeletal origin pain (myofascial pain syndrome, shoulder pain, and lower back pain).

Timeline

• Start date: 2021-04-30
• Primary completion: 2021-05-25
• Completion: 2021-06-15
• First posted: 2021-04-06
• Last updated: 2021-04-22

Locations

1 site across 1 country: South Korea