Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain
16. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
24
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Scottsdale, Arizona, Forente stater, 85260
- Royal Spine Surgery, Scottsdale, AZ, USA
-
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Colorado
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Denver, Colorado, Forente stater, 80211
- Aria Integrative Health
-
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Texas
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Houston, Texas, Forente stater, 77027
- River Oaks Hospital & Clinics
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Active treatment with 043_CTUS100
|
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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
|
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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.
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Baseline and 3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. august 2024
Primær fullføring (Faktiske)
5. mars 2025
Studiet fullført (Faktiske)
5. mars 2025
Datoer for studieregistrering
Først innsendt
16. juni 2026
Først innsendt som oppfylte QC-kriteriene
16. juni 2026
Først lagt ut (Faktiske)
22. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BTL-043_CTUS100
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .