Not Yet RecruitingNot Applicable

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

Mexico60 participantsStarted 2026-06-15

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). * Predominantly mechanical pain, exacerbated by activities such as prolonged standing, trunk movements, extension, or lumbar rotation, and without clinical data of predominant radicular pain. * Plain radiograph of the lumbar spine available as part of the baseline evaluation. * Ability to attend all 4 treatment sessions and subsequent follow-up evaluations. * Signed informed consent form previously approved by the Institutional Review Board / Research Ethics Committee. 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses focal extracorporeal shock wave therapy — a treatment I may not be familiar with — so could you explain how it works for chronic low back pain and whether it's something you've used with your other patients?
2The trial is comparing two different dosing regimens of the same shock wave therapy — can you help me understand what the practical difference between those doses might mean for my safety and comfort during treatment?
3Since this trial isn't recruiting yet, how long do you think it might be before it opens, and should I be considering other treatments in the meantime rather than waiting?
4The main thing being measured is change in pain intensity using a VAS pain scale — based on what you know about shock wave therapy research so far, do you think this approach shows enough promise to be worth considering over standard treatments I might try now?
5Given that this study is listed as Phase NA, meaning it may not follow a traditional drug-trial phase structure, what does that tell us about how much safety and effectiveness data already exists for focal shock wave therapy in chronic low back pain?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)

Timeframe: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment

Trial details

NCT IDNCT07646132

SponsorArmando Tonatiuh Avila Garcia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Armando Tonatiuh Ávila García, MD

523339424400 atavila@hcg.gob.mx

View on ClinicalTrials.gov More Chronic Low Back Pain (CLBP) trials