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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Eksperimentel: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Lumbar Functional Disability Using the Oswestry Disability Index (ODI)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Armando Tonatiuh Avila Garcia

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

30. december 2027

Studieafslutning (Anslået)

30. januar 2028

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CEI 121/26

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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Kliniske forsøg med Kronisk lænderygsmerter (CLBP)

Kliniske forsøg med Focal Extracorporeal Shock Wave Therapy (F-ESWT)

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