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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorArmando Tonatiuh Avila Garcia

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Focal Extracorporeal Shock Wave Therapy (F-ESWT)

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Armando Tonatiuh Avila Garcia

Lead sponsor

Hospital Civil de Guadalajara

Sponsor institution