An interventional study of Device: Treatment with BTL-043 in Back Pain and Chronic Back Pain, sponsored by BTL Industries Ltd.. Completed at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →BTL Industries Ltd. is the lead sponsor of 71 studies on the registry; 4 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
Exclusion Criteria:
Device: 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.
Also known as: EMVITAL
Change from Baseline in the Oswestry Disability Index (ODI) Score at 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.
Time frame: Baseline and 3 months
Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 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.
Time frame: Baseline and 3 months
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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BTL Industries Ltd.