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.
Chronic mechanical low back pain is a common musculoskeletal condition that leads to functional disability and diminished quality of life. While focal extracorporeal shock wave therapy (F-ESWT) has emerged as a non-invasive treatment option to promote tissue regeneration and modulate inflammation, clinical protocols lack precise standardization regarding energy density and session distribution. This randomized, double-blind clinical trial aims to analyze the clinical effects of two specific dosing regimens of F-ESWT. Eligible participants from the Physical Medicine and Rehabilitation Service will be randomly allocated to either Group A or Group B. Both groups will undergo targeted applications to the lumbar region using predefined therapeutic parameters detailed in the protocol. Clinical evaluations will be performed at baseline and during post-treatment follow-up periods. Pain intensity, functional disability, and localized mobility will be measured using validated clinical tools to define which dosing scheme optimizes short-term and mid-term patient recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Non-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.
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Medicina Física y Rehabilitación
Guadalajara, Jalisco, Mexico
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.
Time frame: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
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.
Time frame: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
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.
Time frame: From the first treatment session up to 12 months post-treatment
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