Safety and Efficacy of the BTL-043 and BTL-899 Devices in Alleviating Back Pain

Conditions

• Back Pain

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Treatment with BTL-043 — DEVICE
  All of the study subjects will receive the treatment with BTL-043, with the treatment applied before BTL-899. Therapy time will be set to 30 minutes. 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.
• BTL-899 — DEVICE
  All of the study subjects will receive four treatments with BTL-899. The treatment administration phase will consist of four (4) treatment visits, delivered 5-10 days apart. Subjects will undergo the BTL-899 treatment, immediately after BTL-043 treatment. Therapy time will be set to 30 minutes.

Study Details

The study will evaluate the clinical efficacy and performance of the BTL-043 and BTL-899 devices for alleviating back pain. It 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. At the baseline visit, the Oswestry Disability Index (ODI), Visual Analogue Scale for pain (VAS), the Quebec Back Pain Disability Index (QBPDS), palpation of the treatment area, Fingertip-to-Floor-Flexion (FTFF) test, and Lateral FTFF test will be performed. Additionally, two-dimensional (2D) photographs of the subject's posture from the left and right profile will be taken, their Fitzpatrick skin type assessed, and the subject's weight and height will be recorded. The treatment administration phase will consist of four (4) treatment visits, delivered 5-10 days apart. During each treatment visit, subjects will receive treatments with both study devices, BTL-043 and BTL-899, consecutively, one immediately after the other. Therapy time will be set to 30 minutes for each treatment with each study device. After the last treatment, the subjects will complete the ODI, QBPDS, the Therapy Comfort Questionnaire (TCQ), and the Subject Satisfaction Questionnaire \& Quality of Life Questionnaire (SSQ \& QoL), along with the VAS, undergo palpation of the treatment area, FTFF, Lateral FTFF, weight and height measurements, and 2D photographing. During the 1-month and 3-month follow-up visits, the subjects will complete the SSQ \& QoL, the ODI, QBPDS, VAS, undergo palpation of the treatment area, FTFF, Lateral FTFF, weight and height measurements, and 2D photographing. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits.

Key Dates

First listed

Jul 14, 2026

Start date

Dec 8, 2025

Status verified

Jun 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Active Comparator: Active treatment with BTL-043 and BTL-899
  All subjects will receive treatment with the BTL-043 and BTL-899 devices. All of the study subjects will receive the treatment with both study devices, BTL-043 and BTL-899, per one treatment visit and will undergo the treatments consecutively, one immediately after the other, with BTL-043 applied first. The treatment administration phase will consist of four (4) treatment visits, delivered 5-10 days apart. Therapy time will be set to 30 minutes for each treatment with each study device.

Primary Outcome Measure

Change from Baseline in the Visual Analogue Scale (VAS) Score at 3 Months [ Time Frame: Baseline and 3 months ]

Locations (4)

Find similar trials in Scottsdale, AZ

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