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A Study of the Efficacy of Peripheral Magnetic Stimulation in Patients with Chronic Low Back Pain -Randomized controlled trial-

(rPMS on CLBP patients)

Study of rPMS for chronic low back pain

Ishikawa Aiko

Juntendo University School of Medicine Juntendo Hospital

3-1-3 Hongo, Bunkyo-ku, Tokyo

ak-ishikawa@juntendo.ac.jp

Ishikawa Aiko

Juntendo University School of Medicine Juntendo Hospital

3-1-3 Hongo, Bunkyo-ku, Tokyo

+81-3-3813-3111

ak-ishikawa@juntendo.ac.jp

Recruiting

Feb. 28, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

Patients with chronic low back pain
Subjects who meet the following selection criteria
1) Adults between 60 and 85 years old
2) More than 3 months have passed since the onset of low back pain
3) They are in stable general condition (stable vital signs)
4) Want to receive exercise therapy for low back pain
5) Have given a full explanation of the study and have given written consent of their own free will
6) Able to visit the hospital according to the research schedule

Persons who meet any of the following criteria
1) Have a cardiac pacemaker, cardiac prosthetic valve, or indwelling cardiac catheter
2) Have NYHA II degree or higher heart failure
3) Have apparent intracranial hypertension
4) Have a medical pump
5) Dependent on intravascular or extracorporeal life support devices
6) May have metal fragments or ferromagnetic materials in the body
7) Have a cochlear implant
8) Have a history of syncope
9) Have a history or family history of epilepsy or seizures
10) Have unhealed burns or skin lesions in the lumbar region
11) Have a tumor, infection, fracture, or other low back pain that requires immediate attention
12) There are conditions such as spinal canal stenosis and lumbar disc herniation that are indications for surgery
13) Severe neuromuscular disease
14) Severe dementia, severe psychiatric illness
15) Other conditions deemed inappropriate by the physician

Both

chronic low back pain

1) rPMS
Repetitive peripheral magnetic stimulation of the lumbar multifidus muscles in patients with chronic low back pain for 20 minutes per session, twice a week for 8 weeks, for a total of 16 sessions.
2) Exercise therapy
Patients will be instructed on core training and stretching as exercise therapy and encouraged to perform them at home.
Intervention group: rPMS+Exercise therapy
Control group: Exercise therapy only
(In consideration of ethics, the control group will be allowed to receive the same rPMS as the intervention group if they wish after the completion of the study.)

low back pain

rPMS

D017116

Subjective pain intensity of low back pain: The change in the Visual analogue scale (VAS) before and after intervention (T0/T1)
(Assessment points T0: before intervention, T1: after intervention)

1) Subjective pain intensity of low back pain: change in T0 (before intervention), T1 (after intervention), and T2 (1 month after intervention) before and after each stimulation on the Visual analogue scale (VAS), and the amount and rate of change in each (excluding 1)
2) Lumbar spine MRI (lumbar muscle mass): T0, T2, and T0/T2 change and rate of change
3) Full body stereoradiography: T0, T2 and T0/T2 change and rate of change
4) Perception and pain quantitative analysis (Pain VisionTM): T0, T1, T2, and amount and rate of change for each
5) Center of gravity sway and center of gravity range of motion in standing position: T0, T1, T2, and amount and rate of change for each
6) Body weight and body composition (body composition analyzer): T0, T1, T2, and amount and rate of change for each
7) Related questionnaires: T0, T1, T2, and amount and rate of change for each
a. Roland-Morris Disability Questionnaire (RMDQ)
b. Tampa Scale for Kinesiophobia-11 (TSK-11)
c. Central sensitization scale: Short form Central Sensitization Inventory Japanese version
(Assessment points T0: before intervention, T1: after intervention, T2: 1 month after intervention)

+81-3-5802-1584

Feb. 25, 2025

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