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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
BTL Industries Ltd.
Study ID
NCT07661082
Status
Completed

Conditions

  • Back Pain
  • Chronic Back Pain

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Device: Treatment with BTL-043 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 9, 2024
Status verified
Jun 2026
Primary completion
Mar 5, 2025
Completion
Mar 5, 2025

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active treatment with 043_CTUS100

Primary Outcome Measure

Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months [ Time Frame: Baseline and 3 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Royal Spine Surgery, Scottsdale, AZ, USAScottsdaleArizona85260-
Aria Integrative HealthDenverColorado80211-
River Oaks Hospital & ClinicsHoustonTexas77027-

Find similar trials in Scottsdale, AZ

By research site
Royal Spine Surgery, Scottsdale, AZ, USA· Scottsdale, AZAria Integrative Health· Denver, CORiver Oaks Hospital & Clinics· Houston, TX

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