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Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain

16. juni 2026 opdateret af: BTL Industries Ltd.

Evaluating the Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain

The study will evaluate the clinical efficacy and performance of the BTL-043 device for alleviating back pain. The study is a prospective, multi-center, open-label, single-arm study. Subjects will be required to complete four (4) treatment visits and two (2) follow-up visits. All of the study subjects will receive the treatment with the subject device. At the baseline visit, the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), and the Quebec Back Pain Disability Index (QBPDS) will be administered. The subject's weight and height will be recorded. The treatment administration phase will consist of four (4) treatments, delivered 2-10 days apart. Therapy time is set to 30 minutes for each treatment. After the last treatment, the subjects will receive the ODI, QBPDS, and the Therapy Comfort Questionnaire to fill in along with the VAS. During the 1-month and 3-month follow-up visits, the subjects will fill in the Subject Satisfaction & Quality of Life Questionnaire, in addition to the ODI, QBPDS, and VAS. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85260
        • Royal Spine Surgery, Scottsdale, AZ, USA
    • Colorado
      • Denver, Colorado, Forenede Stater, 80211
        • Aria Integrative Health
    • Texas
      • Houston, Texas, Forenede Stater, 77027
        • River Oaks Hospital & Clinics

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:

  • Adult subjects seeking treatment for alleviating back pain, and expressing interest in treatment will be considered eligible for the study.
  • Enrollment of the subject will depend on meeting the following criteria:
  • Adults seeking alleviation of pain in the treatment area
  • Age 22 years and older
  • Voluntarily signed an informed consent form
  • Subject is willing to comply with study instructions, to return to the clinic for the required visits
  • Willingness to adhere to and continue current pain management plan
  • Subjects willing and able to maintain their regular (pre-procedure) diet, exercise, and therapy regimen without affecting significant change during study participation
  • Subject willing and able to abstain from partaking in any new treatments other than this study procedure to treat back pain

  • Women of child-bearing potential* are required to use birth control measures during the whole duration of the study

    • Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Exclusion Criteria:

  • A potential subject who meets any of the following criteria will be excluded from participation in the study:
  • Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus
  • Ongoing pregnancy
  • Photosensitivity, medications affecting sensitivity to light
  • Tattoos or other highly-pigmented regions in the treated area
  • Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use
  • Anticoagulant therapy, bleeding disorders
  • Hemorrhage in the treated area
  • Application within 4 to 6 months after radiotherapy
  • Known or suspected malignancy, history of cancer or any type of malignancy
  • Febrile conditions, serious illness, chronic infection
  • Epilepsy
  • Sensory loss in the treatment area
  • Deep vein thrombosis

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Active treatment with 043_CTUS100
Enhed: Device: Treatment with BTL-043
All patients received four treatment sessions with BTL-043, with treatment sessions spaced 2 to 10 days apart. The treatment was applied to the upper, middle, or lower back region based on pain location. BTL-043 uses the TriHIL technology, which combines 1064 nm near-infrared laser energy at a maximum power of 30 W delivered through a hands-free applicator.
Andre navne:
  • EMVITAL

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months
Tidsramme: Baseline and 3 months
Oswestry Disability Index (ODI) The ODI will be used to evaluate the presence and impact of pain on the subjects' lives. The Oswestry Disability Index is a validated questionnaire used in assessment of back related pain and its impact on daily life. It consists of ten (10) items in total. The final score (sum of all items) is then calculated as a percentage of maximum possible points (50). The higher the percentage, the greater the disability.
Baseline and 3 months
Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months
Tidsramme: Baseline and 3 months
The Visual Analogue Scale (VAS) is a self-reported measure used to assess the intensity of back pain experienced by the participants in the treatment area. Participants rate their perceived pain level on a numerical scale ranging from 0 to 10. On this scale, 0 is equivalent to "no pain" and 10 indicates the "worst possible pain". The baseline score is compared to the score collected at the 3-month follow-up visit. A negative change from baseline (a decrease in the VAS score) indicates a reduction in pain intensity and an improvement in the participant's condition over time.
Baseline and 3 months

Samarbejdspartnere og efterforskere

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

Sponsor

BTL Industries Ltd.

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 (Faktiske)

9. august 2024

Primær færdiggørelse (Faktiske)

5. marts 2025

Studieafslutning (Faktiske)

5. marts 2025

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BTL-043_CTUS100

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rygsmerte

Kliniske forsøg med Device: Treatment with BTL-043

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Togo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner