Effect of Peripheral Magnetic Stimulation in Patients With Chronic Lower Back Pain

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.

Conditions

• Low Back Pain

Interventions

DEVICE

rPMS Intervention

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.

DEVICE

rPMS Controle

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.

Sponsors & Collaborators

• Inês Gomes

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2025-11-01

Completion

2025-11-27

Countries

• Portugal

Study Locations