The purpose of this clinical trial is to evaluate and compare the efficacy of two different dosing regimens of focal extracorporeal shock wave therapy (F-ESWT) in patients diagnosed with chronic mechanical low back pain. Participants will be randomly assigned to one of two experimental groups to receive different parameters of shock wave intervention. The main objective is to determine which dosing scheme provides a more significant reduction in pain intensity and a better recovery of lumbar function.
Individuals of both sexes.
Age between 18 and 65 years.
Clinical diagnosis of mechanical chronic low back pain (cLBP), defined as pain localized between the lower costal margin and the gluteal fold, with at least 12 weeks of evolution.
Lumbar pain intensity of at least 5/10 on the Numeric Pain Rating Scale (NPRS).
Low back pain of probable non-mechanical origin or secondary to a specific cause that substantially modifies clinical management.
Clinical data of predominant lumbar radiculopathy, including pain radiating below the knee with a dermatomal distribution, focal motor deficit, objective sensory alterations, or compatible reflex changes.
Diagnosis or suspicion of cauda equina syndrome.
History of previous lumbar spine surgery.
Parallel
Focal Extracorporeal Shock Wave Therapy (F-ESWT)
DeviceNon-invasive shock wave therapy applied to specific painful lumbar points using the BTL-6000 FSWT focused shockwave device. The equipment delivers focused acoustic energy to modulate localized pain and stimulate tissue response, according to the designated dosing regimens established in the study protocol.
Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)
Pain intensity will be evaluated using a 100-mm Visual Analog Scale (VAS), where 0 mm represents "no pain" and 100 mm represents "the worst possible pain". Higher scores indicate greater pain severity. The outcome is measured as the change in millimeter scores from baseline to each subsequent post-treatment follow-up assessment.
Change from Baseline in Lumbar Functional Disability Using the Oswestry Disability Index (ODI)
Functional disability associated with mechanical low back pain will be measured using the Oswestry Disability Index (ODI). The questionnaire consists of 10 items assessing limitations in daily activities. Total scores range from 0% (no disability) to 100% (maximum disability). Higher percentages reflect greater functional impairment.
Incidence of Treatment-Related Adverse Events
Safety and tolerability will be evaluated by monitoring and recording the frequency, severity, and type of any localized adverse events associated with focal extracorporeal shock wave therapy (F-ESWT), such as transient erythema, mild bruising, or temporary pain increase.
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Armando Tonatiuh Avila Garcia
Lead sponsor
Hospital Civil de Guadalajara
Sponsor institution
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