Focal Extracorporeal Shock Wave Therapy With Two Different Dosing Regimens for Chronic Low Back Pain

Exclusion Criteria

• •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.
• •Current vertebral fracture or recent history of lumbar fracture.
• •Spondylolisthesis grade II or higher.
• •Significant structural scoliosis or severe lumbar deformity that prevents treatment standardization.
• •Suspicion or evidence of a tumor, infection, spondylodiscitis, or axial inflammatory disease.
• •Severe clinically documented osteoporosis or history of vertebral fragility fracture.
• •Pregnancy or lactation.
• •Coagulation disorder, use of anticoagulants at therapeutic doses, or a hemorrhagic condition that increases procedure risk.
• •Previous epidural infiltration, facet block, radiofrequency, or other lumbar interventional procedure within a recent period defined by the protocol.
• •Current treatment with another physical rehabilitation modality or instrumental therapy directed at low back pain, if it cannot be suspended during the intervention period.
• •Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) that the patient cannot suspend according to the study indications.
• •Concomitant neurological, rheumatological, oncological, or musculoskeletal disease that significantly interferes with pain or disability evaluation.
• •Cognitive impairment, decompensated psychiatric disorder, or any condition that prevents understanding instructions, answering questionnaires, or completing follow-up.