Effect of Peripheral Magnetic Stimulation in Patients With Chronic Lower Back Pain - Controlled, Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Oswestry Disability Index (ODI)
Study Overview
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.
Detailed Description
Low back pain is one of the most disabling and therapeutically challenging conditions affecting the population. Chronic low back pain is defined as pain and discomfort located below the rib margins and above the gluteal line, with or without pain referred to the lower limbs and represents a considerable challenge in terms of public health, with high financial costs. In Brazil, approximately 10 million Brazilians become disabled by this morbidity and at least 70% of the population will suffer an episode of low back pain in their lifetime.
In young adults, there are numerous studies on the impact of low back pain on functionality and therapeutic interventions, largely due to the high costs to the health service caused by the disability resulting from chronic low back pain in this economically active population. However, despite being identified as an important health problem, its consequences, as well as the effectiveness of therapeutic programs, are little known among the population.
Repetitive peripheral magnetic stimulation (rPMS) is a clinical treatment modality that depends on the generation of a powerful magnetic field by means of an electromagnetic coil. It is a low-intensity current capable of producing electrical impulses with variable frequencies of up to 200 Hz, thus being effective in the treatment of musculoskeletal pain, modeling and influencing pain neuroconduction processes. This electrical stimulation is capable of reducing pain through peripheral stimulation of large diameter fibers (A fibers), ending up inhibiting the entry of painful stimuli conducted by narrow diameter fibers (A delta and C fibers) closing the pain gate.
rPMS increases the cortical-motor excitability of the areas to be stimulated. This stimulation facilitates neuroplastic changes that improve motor recovery in the long term. Its beneficial effects on patients include increased muscle strength and mobility, decreased spasticity, analgesia, reduced edema, vasodilation, and decreased reflex inhibition, among others. However, to the best of our knowledge, no study has investigated the synergistic effects of SMP in patients with chronic low back pain with scores between 40 and 80 on the Oswestry scale. Therefore, it is extremely important to search for effective treatment modalities to improve pain and associated functional disability for the treatment of these patients.
OBJECTIVE General Objective To investigate the effects of rPMS treatment compared to a placebo treatment with the same equipment in reducing pain and functionality in patients with chronic low back pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
rPMS Controle
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.
Intervention: rPMS Controle (Device)
rPMS Intervention
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.
Intervention: rPMS Intervention (Device)
Outcomes
Primary Outcomes
Oswestry Disability Index (ODI)
Time Frame: Baseline and immediately post-treatment (after 10 sessions over 2 weeks)
Disease-specific questionnaire measuring functional disability (0=no disability, 100=complete disability)
Secondary Outcomes
- 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))
- Oswestry Disability Category(Baseline and immediately post-treatment (after 10 sessions over 2 weeks))
- Physical Activity Level (IPAQ)(Baseline and immediately post-treatment (after 10 sessions over 2 weeks))
Investigators
Inês Gomes
Research Support Office
Egas Moniz - Cooperativa de Ensino Superior, CRL