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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment with BTL-043 and BTL-899 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Visual Analogue Scale (VAS) 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 | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months | The ODI is a self-reported, patient-administered questionnaire used to evaluate how low back pain affects everyday activities. 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. |
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Inclusion Criteria:
Exclusion Criteria:
Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Spine Surgery | Scottsdale | Arizona | 85260 | United States | ||
| Novaré Medical and Wellness |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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. |
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| Baseline and 3 months] |
| Change from Baseline in the Quebec Back Pain Disability Scale (QBPDS) Score at 3 Months | The QBPDS is a self-administered questionnaire consisting of 20 items designed to assess the level of functional disability in individuals with back pain. Each item is scored on a scale from 0 to 5, with higher total scores indicating greater disability. The questionnaire will be administered at the baseline, after the last therapy visit, and at both follow up visits. | Baseline and 3 months] |
| Change from Baseline in Fingertip-to-Floor-Flexion (FTFF) at 3 Months | The FTFF is a composite test measuring multiple motions and muscles that will be used to evaluate improvement of subject's movement flexibility. The subject will be asked to bend forward, and the distance between the tip of the middle finger and the floor will be measured with a tape measure. | 3 months post treatment |
| Change from Baseline in Lateral Fingertip-to-Floor-Flexion at 3 Months | The Lateral FTFF is a test measuring lateral flexion that will be used to evaluate improvement of subject's movement flexibility. First the subject will be standing erect, and then the subject will be asked to bend laterally flexing the spine. The distance between the middle finger to the floor will be measured with a tape. The change in distance from erect standing to lateral flexion will be considered the range of lateral flexion. | Baseline and 3 months |
| Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire | Subject satisfaction with the treatment outcomes and its impact on quality of life is assessed using a 16-item self-reported questionnaire. Each item is rated on a 5-point Likert scale, where 1 indicates "strongly disagree" and 5 indicates "strongly agree". Higher scores represent greater treatment satisfaction and improvement in the subject's quality of life. | 3 months post treatment |
| Therapy Comfort Assessed by the Therapy Comfort Questionnaire | Therapy comfort is assessed using a self-reported questionnaire. Participants indicate their overall comfort on a 5-point Likert scale (where 1 is "strongly disagree" and 5 is "strongly agree" with the statement "I found the treatment comfortable"). Additionally, any pain experienced during treatment is rated on a Numerical Analogue Scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Lower pain scores and higher agreement scores indicate greater therapy comfort. | Immediately after the final treatment |
| Change from Baseline in the position measurements of the left and right profile based on the 2D photographs at 3 months | Full-body 2D photographs will be taken from the left and right profiles to evaluate improvement in the subject's posture. Subjects will be asked to stand barefoot, feet shoulder-width apart, positioned adjacent to a wall. | Baseline and 3 months |
| Fort Myers |
| Florida |
| 33908 |
| United States |
| Active Edge Health | Columbus | Ohio | 43215 | United States |
| Pinnacle Integrative Orthopedics | Wichita Falls | Texas | 76301 | United States |