NCT07243548

Brief Summary

The aim of this study is to analyze the effect of Repeated Peripheral Magnetic Stimulation (rPMS) in patients with chronic low back pain. This is a controlled, randomized, multicenter clinical trial (Brazil x Portugal). The sample will consist of individuals with chronic low back pain with a score between 40 and 80 on the Oswestry scale, who will be randomly divided into 2 groups: control (CG) and intervention (IG). The instruments used for evaluation will be: visual analog pain scale (VAS), brief pain inventory (BPI), McGill questionnaire, Roland Morris scale and WHOQOL-BREF. Both groups will use the EMP device, with 10 sessions over a period of 2 weeks, in the IG applied in the flat tangential orientation lasting 20 minutes and an intermittent stimulation protocol consisting of 5 seconds of stimulation at a frequency of 20 Hz followed by 25 seconds of rest with a minimum intensity of 20% up to the maximum intensity to induce sufficient contraction of the paraspinal muscle and in the CG in transverse orientation with the stimulus intensity level set at 5% of the maximum output of the stimulator to minimize stimulation, both in the most painful lumbar region. The Wilcoxon test will be applied. Then, the Mann-Whitney test will be applied, adopting a significance level of 5%. It is expected that this research will contribute to more accurate protocols and evaluation methods for the EMP intervention, which generates responses in pain relief and non-surgical treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

April 16, 2025

Results QC Date

January 12, 2026

Last Update Submit

February 6, 2026

Conditions

Low Back Pain

Keywords

Peripheral magnetic stimulationlow back painchronic painneuromodulation

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index (ODI)

    Disease-specific questionnaire measuring functional disability (0=no disability, 100=complete disability)

    Baseline and immediately post-treatment (after 10 sessions over 2 weeks)

Secondary Outcomes (7)

  • Pain Intensity at Rest (VAS)

    Baseline and immediately post-treatment (after 10 sessions over 2 weeks)

  • Pain Intensity During Activity (VAS)

    Baseline and immediately post-treatment (after 10 sessions over 2 weeks)

  • Pressure Pain Threshold Right Lumbar Region

    Baseline and immediately post-treatment (after 10 sessions over 2 weeks)

  • Pressure Pain Threshold Left Lumbar Region

    Baseline and immediately post-treatment (after 10 sessions over 2 weeks)

  • Lumbar Mobility (Schober Test)

    Baseline and immediately post-treatment (after 10 sessions over 2 weeks)

  • +2 more secondary outcomes

Study Arms (2)

rPMS Controle

EXPERIMENTAL

For patients in the rPMS control group, also in the prone position, the coil will be applied in a transverse orientation to the most painful lumbar region. This position of the coil, at a 90° angle to the body surface, will minimize the effects of the magnetic stimulation applied to the area.

Device: rPMS Controle

rPMS Intervention

EXPERIMENTAL

For patients in the rPMS intervention group - in the prone position - the coil will be placed in a flat tangential orientation targeting the most painful lumbar region. This will allow the coil to be positioned parallel to the body surface, thus maximizing the effects of the magnetic stimulation applied to the area.

Device: rPMS Intervention

Interventions

rPMS InterventionDEVICE

Both groups will undergo 10 sessions over a 2-week period. Each session will last 20 minutes and will be intermittent stimulation protocol consisting of 5 seconds of stimulation at a frequency of 20 Hz followed by 25 seconds of rest. The total number of stimulations over 20 minutes will be 4,000 pulses. The stimulation intensity level will be set at the level that induces sufficient contraction of the paraspinal muscle while still within the tolerable range of the patient. For the rRPMS control group, the stimulus intensity level will be set at 5% of the maximum output of the stimulator to minimize magnetic stimulation. Both groups will be exposed to an identical clicking sound generated during each session and the coil will be placed in contact with the patient (to have a similar sensation). The application of the rRPMS coil in both groups of patients will be conducted by experienced physiotherapists with sufficient preliminary training on the application of rPMS prior to the study.

rPMS Intervention
rPMS ControleDEVICE

Both groups will undergo 10 sessions over a 2-week period. Each session will last 20 minutes and will be intermittent stimulation protocol consisting of 5 seconds of stimulation at a frequency of 20 Hz followed by 25 seconds of rest. The total number of stimulations over 20 minutes will be 4,000 pulses. The stimulation intensity level will be set at the level that induces sufficient contraction of the paraspinal muscle while still within the tolerable range of the patient. For the rRPMS control group, the stimulus intensity level will be set at 5% of the maximum output of the stimulator to minimize magnetic stimulation. Both groups will be exposed to an identical clicking sound generated during each session and the coil will be placed in contact with the patient (to have a similar sensation). The application of the rRPMS coil in both groups of patients will be conducted by experienced physiotherapists with sufficient preliminary training on the application of rPMS prior to the study.

rPMS Controle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with complaints of low back pain for more than three months
  • Non-practitioners of sports activities
  • Absence of significant spinal pathologies, such as previous history of myelopathies, surgeries, instabilities, or deformities (bone fractures)
  • Normal neurological examination for radiculopathies (patellar and Achilles tendon reflexes, voluntary motor function, and sensitivity test)

You may not qualify if:

  • Presence of trauma or systemic dysfunction
  • Use of other alternative treatments
  • Refusal to be randomized
  • Protrusion or prolapse of one or more intervertebral discs with neurological symptoms
  • Previous spinal surgery
  • Infectious spondylopathy
  • Low back pain secondary to inflammation, tumor, or autoimmune disease
  • Congenital spinal deformities
  • Compression fracture caused by osteoporosis, spondylolysis, or spondylolisthesis
  • Use of prosthesis
  • History of seizures or epilepsy
  • Implanted or non-removable intracranial metal or devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egas Moniz School of Health and Science

Almada, Setúbal District, 2829 - 511, Portugal

Location

Related Publications (3)

  • Lim YH, Song JM, Choi EH, Lee JW. Effects of Repetitive Peripheral Magnetic Stimulation on Patients With Acute Low Back Pain: A Pilot Study. Ann Rehabil Med. 2018 Apr;42(2):229-238. doi: 10.5535/arm.2018.42.2.229. Epub 2018 Apr 30.

    PMID: 29765876BACKGROUND

  • Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. Repetitive peripheral magnetic neurostimulation of multifidus muscles combined with motor training influences spine motor control and chronic low back pain. Clin Neurophysiol. 2017 Mar;128(3):442-453. doi: 10.1016/j.clinph.2016.12.020. Epub 2016 Dec 28.

    PMID: 28160750BACKGROUND

  • Diao Y, Pan J, Xie Y, Liao M, Wu D, Liu H, Liao L. Effect of Repetitive Peripheral Magnetic Stimulation on Patients With Low Back Pain: A Meta-analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2023 Sep;104(9):1526-1538. doi: 10.1016/j.apmr.2023.03.016. Epub 2023 Apr 26.

    PMID: 37116558BACKGROUND

MeSH Terms

Conditions

Low Back PainChronic Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

The sample size, although statistically powered, was relatively small, and the follow-up was limited to the immediate post-treatment period, preventing conclusions about long-term efficacy.

Results Point of Contact

Title
Luciano Maia Alves Ferreira
Organization
Egas Moniz School of Health and Science
lucianobatatais@hotmail.com
+351913548646

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Individuals with chronic low back pain with a score between 40 and 80 on the Oswestry scale will be selected, and 40 will be selected for treatment at the Physiotherapy School of the Federal University of Alfenas - MG and the Egas Moniz University Clinic - CUEM. The individuals will be divided into 2 groups: the control group and the intervention group. The volunteers will be divided into a control group and an intervention group through randomization. To this end, the participants will be allocated by another researcher, who will use the Research Randomizer website into two groups: Control Group (CG) and Intervention Group (IG).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Support Office

Study Record Dates

First Submitted

April 16, 2025

First Posted

November 24, 2025

Study Start

May 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 27, 2025

Last Updated

February 25, 2026

Results First Posted

February 25, 2026

Record last verified: 2025-12

Locations

PT(1)