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rTMS on Diabetic Peripheral Neuropathic Pain

NCT04833660 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-04-22

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Min Cheol Chang

    lead OTHER

Principal Investigators

  • Min Cheol Chang · Yuengnam University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-05-25
Completion
2021-06-15

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04833660 on ClinicalTrials.gov