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Focal Extracorporeal Shock Wave Therapy With Two Different Dosing Regimens for Chronic Low Back Pain (ESWT-LBP)

9 juni 2026 bijgewerkt door: Armando Tonatiuh Avila Garcia

Effects of Two Dosing Regimens of Focal Extracorporeal Shock Wave Therapy in Patients With Chronic Low Back Pain: A Randomized Clinical 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Armando Tonatiuh Ávila García, MD
  • Telefoonnummer: 43021 523339424400
  • E-mail: atavila@hcg.gob.mx

Studie Contact Back-up

Studie Locaties

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Medicina Física y Rehabilitación
        • Contact:
          • Armando Tonatiuh Ávila García, MD
          • Telefoonnummer: 71234 523339424400
          • E-mail: atavila@hcg.gob.mx
        • Contact:
        • Hoofdonderzoeker:
          • Armando Tonatiuh Ávila García, MD
        • Onderonderzoeker:
          • Ana Lilia Villagrana Rodríguez, MD
        • Onderonderzoeker:
          • Carlos Fernando Godínez González, MD
        • Onderonderzoeker:
          • Ismael Caballero Quirarte, MD
        • Onderonderzoeker:
          • Daniel Miller Serrano, MD
        • Onderonderzoeker:
          • Aram Jesús Gómez Nájera, MD
        • Onderonderzoeker:
          • José de Jesús Sandoval Zuno, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group A: Regimen 1
Participants in this group will receive focal extracorporeal shock wave therapy (F-ESWT) administered to the lumbar region using the first specific dosing scheme, characterized by designated energy flux density and session frequency parameters as outlined in the protocol.
Apparaat: Focal Extracorporeal Shock Wave Therapy (F-ESWT)
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.
Experimenteel: Group B: Regimen 2
Participants in this group will receive focal extracorporeal shock wave therapy (F-ESWT) administered to the lumbar region using the second specific dosing scheme, characterized by alternative energy flux density and session frequency parameters as outlined in the protocol.
Apparaat: Focal Extracorporeal Shock Wave Therapy (F-ESWT)
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)
Tijdsspanne: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
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.
Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Lumbar Functional Disability Using the Oswestry Disability Index (ODI)
Tijdsspanne: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
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.
Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
Incidence of Treatment-Related Adverse Events
Tijdsspanne: From the first treatment session up to 12 months post-treatment
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.
From the first treatment session up to 12 months post-treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Armando Tonatiuh Avila Garcia

Onderzoekers

  • Hoofdonderzoeker: Tonatiuh Avila Ávila García, MD, Hospital Civil de Guadalajara

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 juni 2026

Primaire voltooiing (Geschat)

30 december 2027

Studie voltooiing (Geschat)

30 januari 2028

Studieregistratiedata

Eerst ingediend

9 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juni 2026

Eerst geplaatst (Werkelijk)

12 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

9 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CEI 121/26

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data underlying the results reported in future publications (including text, tables, and figures) will be made available to researchers for secondary academic and clinical analyses.

IPD-tijdsbestek voor delen

Data will become available beginning 6 months after main publication and will remain accessible for up to 3 years.

IPD-toegangscriteria voor delen

Data will be shared with qualified researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding investigator.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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